fluorouracil and Cancer of Gastrointestinal Tract studies

Fluorouracil: A pyrimidine analog that is an antineoplastic antimetabolite. It interferes with DNA synthesis by blocking the THYMIDYLATE SYNTHETASE conversion of deoxyuridylic acid to thymidylic acid.
5-fluorouracil : A nucleobase analogue that is uracil in which the hydrogen at position 5 is replaced by fluorine. It is an antineoplastic agent which acts as an antimetabolite - following conversion to the active deoxynucleotide, it inhibits DNA synthesis (by blocking the conversion of deoxyuridylic acid to thymidylic acid by the cellular enzyme thymidylate synthetase) and so slows tumour growth.

Research Excerpts

Excerpt	Relevance	Reference
"Patients with GI tumors or breast cancer treated with capecitabine were included in this randomized phase III study."	9.20	Mapisal Versus Urea Cream as Prophylaxis for Capecitabine-Associated Hand-Foot Syndrome: A Randomized Phase III Trial of the AIO Quality of Life Working Group. ( Al-Batran, SE; Bolz, G; Gencer, D; Hegewisch-Becker, S; Hofheinz, RD; Kronawitter, U; Loeffler, LM; Potenberg, J; Schneeweiss, A; Schulz, H; Stahl, M; Tauchert, F, 2015)
"We therefore initiated a Phase II study in which fluorouracil (370 mg/m2, day 1 through 5) plus folinic acid (200 mg/m2 day 1 through 5) was administered in a subset of 17 patients (median age, 57 years) affected by histologically diagnosed adenocarcinoma of unknown primary location characterized by liver metastases and elevated CEA of CA 19."	9.07	Fluorouracil plus folinic acid in metastatic adenocarcinoma of unknown primary site suggestive of a gastrointestinal primary. ( Bajetta, E; Buzzoni, R; Colleoni, M; Nolè, F, 1993)
"Thirty-four patients with advanced adenocarcinoma of the gastrointestinal tract have been treated with high-dose 5-fluorouracil modulated by concomitant allopurinol therapy, in combination with either razoxane or adriamycin."	9.05	A trial of high-dose 5-fluorouracil with razoxane or adriamycin in the treatment of advanced adenocarcinoma of the gastrointestinal tract. ( Ashford, RF; Bakowski, M; Evans, M; Hellman, K; Jones, R; Lambert, J; Newton, K; Peters, N; Phillips, R; Smith, BJ, 1983)
" In this review, we summarized the current status of our knowledge about the effectiveness of curcumin when given in combination with current chemotherapeutics such as 5-fluorouracil, oxaliplatin, and gemcitabine in treatment of gastrointestinal cancers with particular reference to colorectal cancer."	8.85	Synergistic role of curcumin with current therapeutics in colorectal cancer: minireview. ( Majumdar, AP; Patel, BB, 2009)
"We report the case of a 74-years old patient with jejunum adenocarcinoma treated by capecitabine."	8.12	A case of palmar hypopigmentation induced by capecitabine in a gastrointestinal cancer patient. ( Botsen, D; Bouche, O; Gossery, C; Gratiaux, J; Rezzag-Mahcene, C; Slimano, F; Visseaux, L, 2022)
" These individuals are typically asymptomatic until exposed to 5-fluorouracil (5-FU) or capecitabine (which forms 5-FU) for treatment of gastrointestinal or breast cancer."	8.02	Testing for dihydropyrimidine dehydrogenase deficiency in New Zealand to improve the safe use of 5-fluorouracil and capecitabine in cancer patients. ( Burns, K; Findlay, M; Helsby, N; Porter, D; Strother, M, 2021)
"Gastrointestinal cancer and its treatment using fluorouracil-based anticancer agents are risk factors for thiamine deficiency (TD)."	7.96	Potential thiamine deficiency in elderly patients with gastrointestinal cancer undergoing chemotherapy . ( Iimura, Y; Kuroda, S; Momo, K; Yasu, T, 2020)
"The efficacy of triple-drug combination regimens such as docetaxel, cisplatin and 5-fluorouracil (DCF), and epirubicin, oxaliplatin and capecitabine (EOX), is superior to standard cisplatin/5-fluorouracil in patients with upper gastrointestinal adenocarcinoma."	7.79	Comparison between DCF (Docetaxel, Cisplatin and 5-Fluorouracil) and modified EOX (Epirubicin, Oxaliplatin and Capecitabine) as palliative first-line chemotherapy for adenocarcinoma of the upper gastrointestinal tract. ( Asari, R; Ba-Ssalamah, A; Birner, P; Hejna, M; Ilhan-Mutlu, A; Pluschnig, U; Preusser, M; Püspök, A; Schoppmann, SF; Schwameis, K; Zacherl, J, 2013)
" The aim of this study is to retrospectively evaluate the safety and efficacy of adjuvant epirubicin-based triplet chemotherapy and radiotherapy in the treatment of resected locally advanced stomach or gastroesophageal junction adenocarcinoma."	7.79	Postoperative chemoradiotherapy combined with epirubicin-based triplet chemotherapy for locally advanced adenocarcinoma of the stomach or gastroesophageal junction. ( Cai, G; Li, G; Ma, X; Zhang, Z; Zhu, J, 2013)
"The aim of this study was to retrospectively analyze the efficacy and safety of the combination of 5-fluorouracil (5-FU), dacarbazine, and epirubicin (FDE) in 39 patients with advanced, well-differentiated neuroendocrine tumors (NETs)."	7.76	Evaluation of the combination 5-fluorouracil, dacarbazine, and epirubicin in patients with advanced well-differentiated neuroendocrine tumors. ( Bruneton, D; Cassier, PA; Chayvialle, JA; Hervieu, V; Lombard-Bohas, C; Pilleul, F; Scoazec, JY; Walter, T, 2010)
"Three dogs with advanced-stage adenocarcinoma of the gastrointestinal tract were treated by use of resection, adjuvant chemotherapy with cisplatin and 5-fluorouracil, and second-look laparotomy (SLL)."	7.72	Use of cisplatin, 5-fluorouracil, and second-look laparotomy for the management of gastrointestinal adenocarcinoma in three dogs. ( Gilson, SD; Stanclift, RM, 2004)
"To determine the prevalence of tearing and canalicular fibrosis in patients receiving systemic 5-fluorouracil (5-FU) therapy and the reversibility of the symptoms when treatment is stopped."	7.70	Epiphora in patients receiving systemic 5-fluorouracil therapy. ( Burkes, RL; Hassan, A; Hurwitz, JJ, 1998)
"We report the results of an expanded trial of 5-fluorouracil (FUra) combined with high-dose folinic acid for treatment of patients with advanced colorectal or gastric adenocarcinoma."	7.67	Treatment of advanced colorectal and gastric adenocarcinomas with 5-fluorouracil and high-dose folinic acid. ( Benavides, M; Chollet, P; Goldschmidt, E; Machover, D; Marquet, J; Metzger, G; Misset, JL; Schwarzenberg, L; Vandenbulcke, JM; Zittoun, J, 1987)
"28 patients with advanced adenocarcinomas were treated with combinations of 5-fluorouracil and mitomycin-C (FM, 21 patients) or of 5-fluorouracil, adriamycin and mitomycin-C (FAM, 7 patients)."	7.66	[Fluorouracil, mitomycin-C and adriamycin in the treatment of metastasizing gastrointestinal adenocarcinomas]. ( Hammer, B; Jungi, WF; Mayr, AC; Senn, HJ; Späti, B, 1980)
" We then tested the effect of GM-CSF given with a more toxic regimen of 5-FU/LV/IFN-alpha (IFN alpha-2a)."	6.69	A pilot study of interferon alpha-2a, fluorouracil, and leucovorin given with granulocyte-macrophage colony stimulating factor in advanced gastrointestinal adenocarcinoma. ( Allegra, C; Behan, K; Chen, A; Flemming, D; Grem, JL; Grollman, F; Haller, D; Hamilton, JM; Harold, N; Johnston, PG; Lash, A; Liewehr, D; Monahan, B; Morrison, G; Quinn, M; Shapiro, JD; Steinberg, SM; Takimoto, C; Vaughn, D, 1999)
" The maximum tolerated dose (MTD) was defined as the dosage of 5-FU that achieved 60% grade 3/4 toxicity."	6.68	A phase I/II study of leucovorin, carboplatin and 5-fluorouracil (LCF) in patients with carcinoma of unknown primary site or advanced oesophagogastric/pancreatic adenocarcinomas. ( Chang, J; Cunningham, D; Gore, M; Hill, A; Hill, M; Moore, H; Nicolson, M; Norman, A; O'Brien, M; Oates, J; Rigg, A; Ross, P; Watson, M, 1997)
" We were not able to increase 5FU weekly dosage above 700 mg/m2 due to the occurrence of grade 3-4 gastrointestinal toxicity."	6.67	Weekly levofolinic acid and 5-fluorouracil plus hydroxyurea in metastatic gastrointestinal adenocarcinomas. ( Buccellato, C; Cipolla, C; Comande, S; Curto, G; Gebbia, N; Gebbia, V; Latteri, M; Testa, A; Valenza, R, 1994)
"To determine the toxicities and potential for dose escalation of intravenous (IV) bolus fluorouracil (5-FU) given with 500 mg/m2/d leucovorin (LCV) and granulocyte-macrophage colony-stimulating factor (GM-CSF)."	6.67	Phase I and pharmacokinetic study of recombinant human granulocyte-macrophage colony-stimulating factor given in combination with fluorouracil plus calcium leucovorin in metastatic gastrointestinal adenocarcinoma. ( Arbuck, SG; Balis, F; Chen, A; Grem, JL; Hamilton, JM; Jordan, E; McAtee, N; Murphy, RF; Setser, A; Steinberg, S, 1994)
"Of the 7 carcinoid tumors, 2 had partial response, and 2 had stable disease."	5.40	Efficacy of capecitabine and temozolomide combination in well-differentiated neuroendocrine tumors: Jordan experience. ( Abbasi, S; Albaba, H; Kashashna, A, 2014)
"This article describes a woman with metastatic upper gastrointestinal cancer who developed thoracic myelopathy unexpectedly after standard dosage and fractionation radiotherapy."	5.33	Myelopathy after radiation therapy and chemotherapy with capecitabine and gemcitabine. ( Barstis, JL; Black, AC, 2005)
"5-Fluorouracil is an S-phase-specific, synthetic pyrimidine antimetabolite, which is used as a cytostatic agent for a variety of malignant lesions, either singly or in multidrug regimens."	5.30	Supraventricular arrhythmia: a complication of 5-fluorouracil therapy. ( Ahmad, M; Aziz, SA; Iqbal, K; Jalal, S; Mohi-ud-Din, K; Tramboo, NA, 1998)
"However, stomatitis is one of the limiting side effects."	5.28	Treatment of 5-fluorouracil-induced stomatitis by allopurinol mouthwashes. ( Elzawawy, A, 1991)
"Patients with hepatic metastases have 5-FU TBCs about half that of those found in patients without hepatic involvement."	5.26	Clearance of continuously infused 5-fluorouracil in adults having lung or gastrointestinal carcinoma with or without hepatic metastases. ( Byfield, JE; Floyd, RA; Frankel, SS; Griffiths, JC; Hornbeck, CL, 1982)
"Patients with GI tumors or breast cancer treated with capecitabine were included in this randomized phase III study."	5.20	Mapisal Versus Urea Cream as Prophylaxis for Capecitabine-Associated Hand-Foot Syndrome: A Randomized Phase III Trial of the AIO Quality of Life Working Group. ( Al-Batran, SE; Bolz, G; Gencer, D; Hegewisch-Becker, S; Hofheinz, RD; Kronawitter, U; Loeffler, LM; Potenberg, J; Schneeweiss, A; Schulz, H; Stahl, M; Tauchert, F, 2015)
"For moderately emetogenic chemotherapy, palonosetron (PALO) is reported to provide complete control of chemotherapy-induced nausea and vomiting (CINV) in 69% of patients."	5.16	Antiemetic control with palonosetron in patients with gastrointestinal cancer receiving a fluoropyrimidine-based regimen in addition to either irinotecan or oxaliplatin: a retrospective study. ( Bekaii-Saab, T; Blazer, M; Efries, D; Griffith, N; Juergens, K; Phillips, G; Reardon, J; Rose, J; Smith, Y; Weatherby, L, 2012)
" This study determined the maximum-tolerated dose (MTD), toxicity, and pharmacokinetics of irinotecan (CPT-11), capecitabine, and epirubicin in patients with metastatic adenocarcinoma of lung, breast, or gastrointestinal tract."	5.13	Phase I dose escalation study with irinotecan, capecitabine, epirubicin, and granulocyte colony-stimulating factor support for patients with solid malignancies. ( Becerra, CR; Frenkel, EP; Tavana, D; Tran, HT; Verma, UN; Williams, NS, 2008)
"Oxaliplatin (OXA) and irinotecan (IRI) are active drugs in first-line as well as second-line treatment of advanced colorectal cancer patients, their toxicity profiles are not overlapping, and both drugs have shown synergism with folinic acid-modulated 5-fluorouracil (5-FU)."	5.10	Oxaliplatin plus irinotecan and leucovorin-modulated 5-fluorouracil triplet regimen every other week: a dose-finding study in patients with advanced gastrointestinal malignancies. ( Avallone, A; Casaretti, R; Comella, G; Comella, P; De Rosa, V; Fiore, F; Izzo, F; Lapenta, L, 2002)
"Twenty-nine patients with adenocarcinomas of gastrointestinal or unknown primary, and three with advanced neuroendocrine tumours, were entered into a study of bolus plus infusional 5-fluorouracil (FUra) modulated with high-dose leucovorin (LV) and recombinant interferon alpha 2a (IFN-alpha)."	5.07	Double modulation of 5-fluorouracil with interferon alpha 2a and high-dose leucovorin: a phase I and II study. ( Hall, MR; Johnson, PW; Seymour, MT; Slevin, ML; Wrigley, PF, 1994)
"We therefore initiated a Phase II study in which fluorouracil (370 mg/m2, day 1 through 5) plus folinic acid (200 mg/m2 day 1 through 5) was administered in a subset of 17 patients (median age, 57 years) affected by histologically diagnosed adenocarcinoma of unknown primary location characterized by liver metastases and elevated CEA of CA 19."	5.07	Fluorouracil plus folinic acid in metastatic adenocarcinoma of unknown primary site suggestive of a gastrointestinal primary. ( Bajetta, E; Buzzoni, R; Colleoni, M; Nolè, F, 1993)
"Thirty-four patients with advanced adenocarcinoma of the gastrointestinal tract have been treated with high-dose 5-fluorouracil modulated by concomitant allopurinol therapy, in combination with either razoxane or adriamycin."	5.05	A trial of high-dose 5-fluorouracil with razoxane or adriamycin in the treatment of advanced adenocarcinoma of the gastrointestinal tract. ( Ashford, RF; Bakowski, M; Evans, M; Hellman, K; Jones, R; Lambert, J; Newton, K; Peters, N; Phillips, R; Smith, BJ, 1983)
"One hundred and thirty-two previously untreated patients with metastatic adenocarcinoma of the gastrointestinal (GI) tract were randomized to receive either a 120-hr infusion of 5-fluorouracil (5FU) with mitomycin-C or mitomycin-C alone."	5.04	Mitomycin-C alone and in combination with infused 5-fluorouracil to the treatment of disseminated gastrointestinal carcinomas. ( Baker, LH; Buroker, TR; Kim, PN; Ratanatharathron, V; Vaitkevicius, VK; Wojtaszak, B, 1978)
"In a prospective, multi-centre, randomized study of 109 patients with metastatic gastro-intestinal adenocarcinomas the response rate, survival time and side-effects of two drug combinations, carmustin +5-fluorouracil and carmustin + ftorafur, were compared (same carmustin dosage in both groups)."	5.04	[A prospective multi-centre study of the response of metastatic gastrointestinal tumours (author's transl)]. ( Arnold, H; Drings, P; Geldmacher, J; Hartwich, G; Kredel, L; Mayer, M; Neidhardt, B; Queisser, W; Rösch, W; Schaefer, J; von Oldershausen, HF; Wahrendorf, J, 1979)
" In this review, we summarized the current status of our knowledge about the effectiveness of curcumin when given in combination with current chemotherapeutics such as 5-fluorouracil, oxaliplatin, and gemcitabine in treatment of gastrointestinal cancers with particular reference to colorectal cancer."	4.85	Synergistic role of curcumin with current therapeutics in colorectal cancer: minireview. ( Majumdar, AP; Patel, BB, 2009)
" This demonstration was achieved using a 5-day infusion of 5-fluorouracil, leucovorin, and oxaliplatin in patients with colorectal cancer metastases."	4.79	Chronotherapy for gastrointestinal cancers. ( Lévi, F, 1996)
" Studies show a definite therapeutic advantage for folinic acid/5-fluorouracil (5-FU) regimen compared with single agent 5-FU given intravenously in the management of advanced colorectal cancer."	4.78	Clinical trials with 5-fluorouracil, folinic acid and cisplatin in patients with gastrointestinal malignancies. ( Avvento, L; Madajewicz, S, 1990)
"We report the case of a 74-years old patient with jejunum adenocarcinoma treated by capecitabine."	4.12	A case of palmar hypopigmentation induced by capecitabine in a gastrointestinal cancer patient. ( Botsen, D; Bouche, O; Gossery, C; Gratiaux, J; Rezzag-Mahcene, C; Slimano, F; Visseaux, L, 2022)
" These individuals are typically asymptomatic until exposed to 5-fluorouracil (5-FU) or capecitabine (which forms 5-FU) for treatment of gastrointestinal or breast cancer."	4.02	Testing for dihydropyrimidine dehydrogenase deficiency in New Zealand to improve the safe use of 5-fluorouracil and capecitabine in cancer patients. ( Burns, K; Findlay, M; Helsby, N; Porter, D; Strother, M, 2021)
"Gastrointestinal cancer and its treatment using fluorouracil-based anticancer agents are risk factors for thiamine deficiency (TD)."	3.96	Potential thiamine deficiency in elderly patients with gastrointestinal cancer undergoing chemotherapy . ( Iimura, Y; Kuroda, S; Momo, K; Yasu, T, 2020)
"The efficacy of triple-drug combination regimens such as docetaxel, cisplatin and 5-fluorouracil (DCF), and epirubicin, oxaliplatin and capecitabine (EOX), is superior to standard cisplatin/5-fluorouracil in patients with upper gastrointestinal adenocarcinoma."	3.79	Comparison between DCF (Docetaxel, Cisplatin and 5-Fluorouracil) and modified EOX (Epirubicin, Oxaliplatin and Capecitabine) as palliative first-line chemotherapy for adenocarcinoma of the upper gastrointestinal tract. ( Asari, R; Ba-Ssalamah, A; Birner, P; Hejna, M; Ilhan-Mutlu, A; Pluschnig, U; Preusser, M; Püspök, A; Schoppmann, SF; Schwameis, K; Zacherl, J, 2013)
" The aim of this study is to retrospectively evaluate the safety and efficacy of adjuvant epirubicin-based triplet chemotherapy and radiotherapy in the treatment of resected locally advanced stomach or gastroesophageal junction adenocarcinoma."	3.79	Postoperative chemoradiotherapy combined with epirubicin-based triplet chemotherapy for locally advanced adenocarcinoma of the stomach or gastroesophageal junction. ( Cai, G; Li, G; Ma, X; Zhang, Z; Zhu, J, 2013)
" They had osteosarcoma in methotrexate group (n=7), gastrointestinal malignancies in 5FU group (n=9) and breast cancer in the capecitabine group (n=2)."	3.78	Relationship between antimetabolite toxicity and pharmacogenetics in Turkish cancer patients. ( Akbulut, H; Demirkazik, A; Dincol, D; Dogan, M; Icli, F; Karabulut, HG; Tukun, A; Utkan, G; Yalcin, B, 2012)
"Diarrhea is a side effect of a 5-fluorouracil (5-FU) anti-cancer drug-induced intestinal mucosal disorder, which sometimes becomes more severe."	3.77	[Diamine oxidase as blood biomarker in rats and humans to GI tract toxicity of fluorouracil anti-cancer drugs]. ( Goto, T; Kouchi, Y; Matsubara, T; Moriyama, K; Nemoto, H; Sanada, Y; Sasaya, S; Yoshizawa, Y, 2011)
" The aim of the present report was to evaluate real-life drug adherence in a prospective cohort analysis of patients with gastrointestinal or breast cancer treated with capecitabine-based chemotherapy."	3.77	Self-reported compliance with capecitabine: findings from a prospective cohort analysis. ( Bressoud, A; Delmore, G; Hermann, F; Hoesli, P; Pederiva, S; von Moos, R; Winterhalder, R, 2011)
"The aim of this study was to retrospectively analyze the efficacy and safety of the combination of 5-fluorouracil (5-FU), dacarbazine, and epirubicin (FDE) in 39 patients with advanced, well-differentiated neuroendocrine tumors (NETs)."	3.76	Evaluation of the combination 5-fluorouracil, dacarbazine, and epirubicin in patients with advanced well-differentiated neuroendocrine tumors. ( Bruneton, D; Cassier, PA; Chayvialle, JA; Hervieu, V; Lombard-Bohas, C; Pilleul, F; Scoazec, JY; Walter, T, 2010)
"Three dogs with advanced-stage adenocarcinoma of the gastrointestinal tract were treated by use of resection, adjuvant chemotherapy with cisplatin and 5-fluorouracil, and second-look laparotomy (SLL)."	3.72	Use of cisplatin, 5-fluorouracil, and second-look laparotomy for the management of gastrointestinal adenocarcinoma in three dogs. ( Gilson, SD; Stanclift, RM, 2004)
"To determine the prevalence of tearing and canalicular fibrosis in patients receiving systemic 5-fluorouracil (5-FU) therapy and the reversibility of the symptoms when treatment is stopped."	3.70	Epiphora in patients receiving systemic 5-fluorouracil therapy. ( Burkes, RL; Hassan, A; Hurwitz, JJ, 1998)
" Nine patients had symptoms resembling myocardial ischemia, one patient died due to assumed myocardial infarction related closely to fluorouracil treatment, four patients had supraventricular arrhythmia, and one patient had congestive heart failure."	3.68	Cardiotoxicity of 5-fluorouracil in combination with folinic acid in patients with gastrointestinal cancer. ( Bokemeyer, C; Harstrick, A; Hiddemann, W; Köhne-Wömpner, CH; Mügge, A; Papageorgiou, E; Poliwoda, H; Schöber, C; Stahl, M; Wilke, H, 1993)
"Thirty-one assessable patients with metastatic adenocarcinoma of the gastrointestinal tract were entered onto a pilot study designed to assess the impact of recombinant interferon alpha-2a (rIFN alpha-2a) on the toxicity and pharmacokinetics of fluorouracil (5-FU) and leucovorin (LV)."	3.68	A pilot study of interferon alfa-2a in combination with fluorouracil plus high-dose leucovorin in metastatic gastrointestinal carcinoma. ( Balis, FM; Goldstein, LJ; Grem, JL; Hamilton, JM; Kramer, BS; McAtee, N; Murphy, RF; Sartor, O; Sorensen, JM; Steinberg, SM, 1991)
"Fifty-one patients with metastatic adenocarcinoma received Folinic Acid (FA) combined with 5-Fluorouracil (5FU) in a Phase I-II clinical trial."	3.67	5-Fluorouracil and folinic acid: a Phase I-II trial in gastrointestinal malignancy. ( Budd, GT; Bukowski, RM; Cunningham, J; Purvis, J; Weick, JK, 1984)
"We report the results of an expanded trial of 5-fluorouracil (FUra) combined with high-dose folinic acid for treatment of patients with advanced colorectal or gastric adenocarcinoma."	3.67	Treatment of advanced colorectal and gastric adenocarcinomas with 5-fluorouracil and high-dose folinic acid. ( Benavides, M; Chollet, P; Goldschmidt, E; Machover, D; Marquet, J; Metzger, G; Misset, JL; Schwarzenberg, L; Vandenbulcke, JM; Zittoun, J, 1987)
"Fourteen patients with adenocarcinoma of the gastrointestinal tract and pancreas treated with mitomycin C(MMC) and 5-fluorouracil (5-FU) had renal impairment 6-11 months from the beginning of MMC therapy."	3.66	Renal disease after mitomycin C therapy. ( Hanna, WT; Krauss, S; Murphy, WM; Regester, RF, 1981)
"28 patients with advanced adenocarcinomas were treated with combinations of 5-fluorouracil and mitomycin-C (FM, 21 patients) or of 5-fluorouracil, adriamycin and mitomycin-C (FAM, 7 patients)."	3.66	[Fluorouracil, mitomycin-C and adriamycin in the treatment of metastasizing gastrointestinal adenocarcinomas]. ( Hammer, B; Jungi, WF; Mayr, AC; Senn, HJ; Späti, B, 1980)
" A population pharmacokinetic approach was used to determine oxaliplatin and 5-fluorouracil pharmacokinetics with and without ibudilast."	2.94	Ibudilast for prevention of oxaliplatin-induced acute neurotoxicity: a pilot study assessing preliminary efficacy, tolerability and pharmacokinetic interactions in patients with metastatic gastrointestinal cancer. ( Blinman, PL; Dhillon, HM; Galettis, P; McLachlan, AJ; Proschogo, N; Reuter, SE; Teng, C; Vardy, JL, 2020)
" This phase I trial sought to determine the maximum tolerable dose (MTD) of bevacizumab and sorafenib combined with standard cytotoxic therapy for advanced gastrointestinal (GI) cancers."	2.82	Phase I trial of FOLFIRI in combination with sorafenib and bevacizumab in patients with advanced gastrointestinal malignancies. ( Borad, MJ; Erlichman, C; Grothey, A; Hubbard, JM; Johnson, E; Kim, G; Lensing, J; Puttabasavaiah, S; Qin, R; Wright, J, 2016)
"Aiming at exploring clinical curative effect of oxaliplatin combined with flurouracil in the treatment of gastrointestinal tumor, this study divided 60 patients with gastrointestinal tumor into control and observation groups, each containing 30 patients."	2.80	Clinical curative effect of oxaliplatin combined with flurouracil in the treatment of gastrointestinal tumor. ( Feng, W; Li, B; Liu, Y; Wang, J; Xu, D; Zhuang, J, 2015)
"Mucositis was the most common dose-limiting toxicity."	2.80	A phase 1 clinical trial of sequential pralatrexate followed by a 48-hour infusion of 5-fluorouracil given every other week in adult patients with solid tumors. ( Evande, RE; Grem, JL; Kos, ME; Meza, JL; Schwarz, JK, 2015)
"Pasireotide (SOM230) is a somatostatin analog with high binding affinity for somatostatin receptors including sst1, 2, 3 and 5 and inhibit insulin like growth factor-1."	2.80	Phase I trial of combination of FOLFIRI and pasireotide, a somatostatin analogue, in advanced gastrointestinal malignancies. ( Almhanna, K; Fulp, W; Kim, R; Mahipal, A; Shibata, D; Siegel, E; Springett, G; Williams-Elson, I, 2015)
", in a week-on/week-off schedule, combined with FOLFIRI or FOLFOX."	2.79	Intermittent dosing of axitinib combined with chemotherapy is supported by (18)FLT-PET in gastrointestinal tumours. ( Bendell, JC; Burris, HA; Hoh, CK; Infante, JR; Kim, S; Reid, TR; Rosbrook, B; Tarazi, J, 2014)
" The most frequent common adverse events were nausea, Grades 1 - 2 in 13 patients (81."	2.72	Chronomodulated chemotherapy with oxaliplatin, 5-FU and sodium folinate in metastatic gastrointestinal cancer patients: original analysis of non-hematological toxicity and patient characteristics in a pilot investigation. ( Farker, K; Hippius, M; Höffken, K; Hoffmann, A; Merkel, U; Wedding, U, 2006)
"Pharmacokinetics and non-hematological adverse events could be assessed in all patients included in the study."	2.72	Pharmacokinetics of oxaliplatin and non-hematological toxicity in metastatic gastrointestinal cancer patients treated with chronomodulated oxaliplatin, 5-FU and sodium folinate in a pilot investigation. ( Farker, K; Hippius, M; Höffken, K; Hoffmann, A; Merkel, U; Roskos, M; Wedding, U, 2006)
"The aim of this study was to define the maximum tolerated dose (MTD) of bolus mitomycin C (MMC) in combination with 24 h-continuous infusion of 5-flourouracil (FU) plus folinic acid, and to assess the toxicity and activity in patients with previously treated colorectal and gastric cancer."	2.71	Protracted infusional 5-fluorouracil plus high-dose folinic acid combined with bolus mitomycin C in patients with gastrointestinal cancer: a phase I/II dose escalation study. ( Bokemeyer, C; Hartmann, JT; Hofheinz, RD; Honecker, F; Käfer, G; Kanz, L; Köhne, CH; Nehls, O; Oechsle, K; Quietzsch, D; Wein, A, 2003)
"From 2% to 10% of cancer patients treated with 5-fluorouracil (5-FU) will develop symptomatic cardiotoxicity."	2.71	5-Fluorouracil induces arterial vasocontractions. ( Enderle, MD; Graeven, U; Pahlke, M; Petz, C; Schmiegel, W; Südhoff, T; Teschendorf, C, 2004)
" Pharmacokinetic analysis showed that the addition of 90 mg/m2 or 100 mg/m2 of cisplatin to LV5FU2 significantly reduced the 5FU area under the curve."	2.71	Intensified bimonthly cisplatin with bolus 5-fluorouracil, continuous 5-fluorouracil and high-dose leucovorin (LV5FU2) in Patients with advanced gastrointestinal carcinomas: a phase I dose-finding and pharmacokinetic study. ( Alamanos, Y; Bamias, A; Christodoulou, C; Fountzilas, G; Karavasilis, V; Pavlidis, N; Soulti, K; Syrigos, K; Tzamakou, E, 2004)
"Capecitabine is a highly active oral fluoropyrimidine that is an attractive alternative to 5-fluorouracil in colorectal cancer treatment."	2.71	A phase I clinical and pharmacokinetic study of capecitabine (Xeloda) and irinotecan combination therapy (XELIRI) in patients with metastatic gastrointestinal tumours. ( Bertheault-Cvitkovic, F; Bugat, R; Canal, P; Chatelut, E; Cornen, X; Delord, JP; Dieras, V; Guimbaud, R; Lochon, I; Lokiec, F; Mery-Mignard, D; Mouri, Z; Pierga, JY; Turpin, FL, 2005)
" Three of 7 (43%) patients treated with irinotecan 300 mg/m(2) and capecitabine 2,300 mg/d had course 1 dose-limiting toxicity (DLT) defining maximum tolerated dosage (MTD)."	2.70	Phase I clinical trial of irinotecan with oral capecitabine in patients with gastrointestinal and other solid malignancies. ( Baker, C; Chun, HG; Fehn, K; Goel, S; Hoffman, A; Hopkins, U; Jhawer, M; Landau, L; Makower, D; Mani, S; Rajdev, L; Wadler, S, 2002)
"A comparison of the intratumoral 5-FU pharmacokinetics indicated that there was no general effect of leucovorin on the intratumoral half-life of 5-FU."	2.70	Does leucovorin alter the intratumoral pharmacokinetics of 5-fluorouracil (5-FU)? A Southwest Oncology Group study. ( Jacobson, J; Macdonald, JS; Presant, CA; Waluch, V; Weitz, IC; Wolf, W, 2002)
" We then tested the effect of GM-CSF given with a more toxic regimen of 5-FU/LV/IFN-alpha (IFN alpha-2a)."	2.69	A pilot study of interferon alpha-2a, fluorouracil, and leucovorin given with granulocyte-macrophage colony stimulating factor in advanced gastrointestinal adenocarcinoma. ( Allegra, C; Behan, K; Chen, A; Flemming, D; Grem, JL; Grollman, F; Haller, D; Hamilton, JM; Harold, N; Johnston, PG; Lash, A; Liewehr, D; Monahan, B; Morrison, G; Quinn, M; Shapiro, JD; Steinberg, SM; Takimoto, C; Vaughn, D, 1999)
" Five patients could not tolerate the treatment even at the lowest dose of interferon and 22 patients were unavailable for the pharmacokinetic analysis because of dose reductions of 5-FU."	2.69	A pharmacokinetic study of 5-FU/leucovorin and alpha-interferon in advanced cancer. ( Carlsson, G; Glimelius, B; Gustavsson, B; Jeppsson, B; Jönsson, PE; Larsson, PA; Malmberg, M; Svedberg, M, 2000)
" There was also an increase in plasma uracil and unmetabolised 18F-fluorouracil and an increase in the radiotracer half-life in tumours (2."	2.69	Modulation of fluorouracil tissue pharmacokinetics by eniluracil: in-vivo imaging of drug action. ( Aboagye, EO; Brady, F; Jones, T; Lucas, SV; Osman, S; Price, PM; Saleem, A; Suttle, B; Yap, J, 2000)
"To determine the dose-limiting toxicity of CPT-11 in combination with oxaliplatin, and the maximal tolerated dose (MTD) and the recommended dose (RD) of CPT-11 using an every two weeks schedule."	2.69	Dose escalation of CPT-11 in combination with oxaliplatin using an every two weeks schedule: a phase I study in advanced gastrointestinal cancer patients. ( Cvitkovic, E; Di Palma, M; Goldwasser, F; Gross-Goupil, M; Marceau-Suissa, J; Misset, JL; Tigaud, JM; Wasserman, E; Yovine, A, 2000)
"In the present study, repeated hepatic dearterialization combined with intra-arterial infusion chemotherapy was performed in patients with unresectable tumors of the liver."	2.68	[Efficacy of repeated hepatic dearterialization combined with intra-arterial infusion chemotherapy for unresectable tumors of the liver]. ( Hashimoto, N; Hayashi, T; Kohno, H; Kubota, H; Nagasue, N; Ono, T; Uchida, M; Yamanoi, A, 1995)
"5-fluorouracil was given as a continuous infusion."	2.68	A randomised study to determine whether routine intravenous magnesium supplements are necessary in patients receiving cisplatin chemotherapy with continuous infusion 5-fluorouracil. ( Beveridge, IG; Evans, TR; Harper, CL; Mansi, JL; Wastnage, R, 1995)
"The purpose of this study was to evaluate a potential pharmacokinetic (PK) interaction between fluorouracil (5-FU) and the biomodulating agent interferon alpha (IFN-alpha) in patients with metastatic colorectal carcinoma."	2.68	Pharmacokinetic interaction of 5-fluorouracil and interferon alpha-2b with or without folinic acid. ( b1p6uller, J; Czejka, M, 1995)
"Diarrhea was less frequent (p = 0."	2.68	A phase II study of oral fluorouracil for gastrointestinal cancer. ( Cartei, F; Cartei, G; Giraldi, T; Imperato, A; Interlandi, G; Meneghini, G; Tabaro, G; Vigevani, E, 1996)
" The maximum tolerated dose (MTD) was defined as the dosage of 5-FU that achieved 60% grade 3/4 toxicity."	2.68	A phase I/II study of leucovorin, carboplatin and 5-fluorouracil (LCF) in patients with carcinoma of unknown primary site or advanced oesophagogastric/pancreatic adenocarcinomas. ( Chang, J; Cunningham, D; Gore, M; Hill, A; Hill, M; Moore, H; Nicolson, M; Norman, A; O'Brien, M; Oates, J; Rigg, A; Ross, P; Watson, M, 1997)
" The half-life in the peritoneal fluid (t1/2p) and the rate constant from the peritoneal fluid to the systemic circulation (ka) were nearly equal for both 5-fluorouracil and mitomycin C (t1/2p, 1."	2.67	Pharmacokinetic characteristics of 5-fluorouracil and mitomycin C in intraperitoneal chemotherapy. ( Hasegawa, M; Hasegawa, T; Ito, A; Kuzuya, T; Nabeshima, T; Yamauchi, M, 1994)
"Vomiting was not consistently related to the excretion of either catecholamine."	2.67	Delayed chemotherapy-induced nausea is augmented by high levels of endogenous noradrenaline. ( Börjesson, S; Fredrikson, M; Fürst, CJ; Hursti, TJ; Peterson, C; Steineck, G, 1994)
" QDBS syndrome is somehow related to immuno-deficiency and blood hypercoagulability, the method of Yiqi Huoxue (YQHX) which used to be combined with chemotherapy could not only reduce the toxic-side effects of chemotherapy, but also improve the cellular immune function and hemorheology."	2.67	[Studies of guben quyu No I combined with chemotherapy in treating cancer]. ( Peng, XM; Rao, XQ; Yu, RC, 1994)
" We were not able to increase 5FU weekly dosage above 700 mg/m2 due to the occurrence of grade 3-4 gastrointestinal toxicity."	2.67	Weekly levofolinic acid and 5-fluorouracil plus hydroxyurea in metastatic gastrointestinal adenocarcinomas. ( Buccellato, C; Cipolla, C; Comande, S; Curto, G; Gebbia, N; Gebbia, V; Latteri, M; Testa, A; Valenza, R, 1994)
"To determine the toxicities and potential for dose escalation of intravenous (IV) bolus fluorouracil (5-FU) given with 500 mg/m2/d leucovorin (LCV) and granulocyte-macrophage colony-stimulating factor (GM-CSF)."	2.67	Phase I and pharmacokinetic study of recombinant human granulocyte-macrophage colony-stimulating factor given in combination with fluorouracil plus calcium leucovorin in metastatic gastrointestinal adenocarcinoma. ( Arbuck, SG; Balis, F; Chen, A; Grem, JL; Hamilton, JM; Jordan, E; McAtee, N; Murphy, RF; Setser, A; Steinberg, S, 1994)
"Four of ten patients with colorectal cancer responded to the treatment (four partial responses), of whom three had been treated previously."	2.67	A phase I, II study of high-dose 5-fluorouracil and high-dose leucovorin with low-dose phosphonacetyl-L-aspartic acid in patients with advanced malignancies. ( Ardalan, B; Benedetto, P; Feun, L; Fodor, M; Livingstone, A; Morrell, L; Richman, S; Savaraj, N; Sridhar, KS; Waldman, S, 1991)
"Fifty of 80 cases had advanced gastric cancer, 30 had pancreatic cancer or other cancers, such as colon cancer, and biliary tract cancer."	2.66	[Controlled study of MQF-OK therapy with FT and with UFT on various advanced gastrointestinal cancers. Hirosaki Cooperative Study Group of Cancer Chemotherapy]. ( Baba, T; Furukohori, N; Itoh, T; Kawata, K; Kimura, T; Munakata, A; Saitoh, S; Sakata, Y; Suzuki, H; Tamura, Y, 1988)
" Part II of the trial revealed that neither a higher dosage of ftorafur (2 g/m2/day X 5 days) nor the addition of vincristine to both regimens changed the previously obtained results significantly."	2.65	Comparison of ftorafur with 5-fluorouracil in combination chemotherapy of advanced gastrointestinal carcinoma. ( Arnold, H; Drings, P; Fritze, D; Geldmacher, J; Hartwich, G; Herrmann, R; Kempf, P; König, H; Meiser, RJ; Nedden, R; Pappas, A; Queisser, W; Schaefer, J; Schnitzler, G; Sievers, H; von Oldershausen, HF; Wahrendorf, J; Westerhausen, M; Witte, S, 1981)
" With the dosage and schedule we used, and in our patient population of largely elderly adults, THC therapy resulted in an overall more unpleasant treatment experience than that noted with prochlorperazine or placebo."	2.65	Delta-9-tetrahydrocannabinol as an antiemetic for patients receiving cancer chemotherapy. A comparison with prochlorperazine and a placebo. ( Creagan, ET; Frytak, S; Moertel, CG; O'Connell, MJ; O'Fallon, JR; Rubin, J; Schutt, AJ; Schwartau, NW, 1979)
"Trifluridine/tipiracil is an oral chemotherapeutic agent recently approved for third-line treatment of chemorefractory metastatic colorectal cancer."	2.58	Trifluridine/tipiracil: an emerging strategy for the management of gastrointestinal cancers. ( Cervantes, A; Moreno Vera, S; Peeters, M; Taieb, J, 2018)
"Based on the individual genomic profile, the oncologists will have new possibilities, based on the individual genetic profile, to make treatment decisions for their patients and to redefine scheduling and dosage of FluOx-based therapy."	2.52	Rational selection of predictive pharmacogenomics test for the Fluoropyrimidine/Oxaliplatin based therapy. ( Berretta, M; De Lucia, L; De Monaco, A; Del Pup, L; Di Francia, R; Di Martino, S; Di Paolo, M; Lleshi, A, 2015)
"Colorectal cancers have been the first cancers to benefit from an efficient anti-angiogenic treatment, represented by bevacizumab, which has been approved for first-line metastatic treatment in combination with reference chemotherapies and which is under study in the adjuvant setting."	2.44	[Angiogenesis targeting in gastro-intestinal cancers]. ( Meric, JB, 2007)
"Formerly the treatment of gastrointestinal cancers was exclusively surgical."	2.43	[Progress in the treatment of gastrointestinal cancers due to introduction of neoadjuvant concept]. ( Cseke, L; Esik, O; Horváth Ors, P; Kalmár, K; Papp, A; Yousuf, AF, 2006)
"Capecitabine has a favourable safety profile, the most frequent adverse events being hand-foot syndrome, stomatitis and diarrhoea."	2.42	Development of and clinical experience with capecitabine (Xeloda) in the treatment of solid tumours. ( Holland, M; Reichardt, P; Sternberg, CN, 2004)
"For Dukes' C colon cancer, postoperative adjuvant chemotherapy with a combination of fluorouracil and levamisole is now recommended as standard therapy."	2.39	Adjuvant postoperative therapy of gastrointestinal malignancies. ( Ilson, DH; Kelsen, DP, 1994)
"Fluorouracil has been used for a long time, remission rates reported range from 0% to 80%."	2.36	[Chemotherapy of gastrointestinal tumors (review of the literature)]. ( Mayr, AC, 1978)
"Capecitabine is an oral anticancer drug which can cause some adverse reactions and the great challenge for its use is to ensure the medication adherence."	1.72	Adverse reactions and adherence to capecitabine: A prospective study in patients with gastrointestinal cancer. ( Barbosa, CR; Cobaxo, TS; de Souza, RN; Dias, LP; Duarte, NC; Lima, CS; Lima, TM; Moriel, P; Pincinato, EC; Tavares, MG; Teixeira, JC; Visacri, MB, 2022)
"5-Fluorouracil (5-FU) is widely used in combination chemotherapy, and literature suggests pharmacokinetic-guided dosing to improve clinical efficacy and reduce toxicity."	1.62	Systemic exposure to 5-fluorouracil and its metabolite, 5,6-dihydrofluorouracil, and development of a limited sampling strategy for therapeutic drug management of 5-fluorouracil in patients with gastrointestinal malignancy. ( Aruldhas, BW; Chacko, RT; Jacob, J; Mathew, BS; Mathew, SK; Prabha, R; Singh, A, 2021)
"We used pancreatic, liver and colon cancer cell lines and isolated CSCs using Aldefluor technology to analyze PARP-1 expression."	1.62	Identification of PARP-1 in cancer stem cells of gastrointestinal cancers: A preliminary study. ( Cepero, A; Martin-Guerrero, SM; Martin-Oliva, D; Melguizo, C; Munoz-Gamez, JA; Ortiz, R; Prados, J; Quinonero, F; Urbano, D, 2021)
" Adverse events occurred in 88."	1.56	Efficacy and Toxicity of 5-Fluorouracil-Oxaliplatin in Gastroenteropancreatic Neuroendocrine Neoplasms. ( Arsenic, R; Dal Buono, A; Denecke, T; Jann, H; Merola, E; Pape, UF; Pavel, ME; Wiedenmann, B, 2020)
"Of raltitrexed-treated patients, 13 (5%) experienced CV toxicities and 1 (< 0."	1.51	Efficacy and Cardiotoxic Safety Profile of Raltitrexed in Fluoropyrimidines-Pretreated or High-Risk Cardiac Patients With GI Malignancies: Large Single-Center Experience. ( Braconi, C; Chau, I; Cunningham, D; Forster, M; Gerlinger, M; Kalaitzaki, E; Khan, K; Rane, JK; Rao, S; Starling, N; Valeri, N; Watkins, D, 2019)
"Severe treatment-related diarrhea may result in chemotherapy discontinuation."	1.51	Fluoropyrimidine-induced intestinal mucosal injury is associated with the severity of chemotherapy-related diarrhea. ( Goto, M; Harada, S; Higuchi, K; Hirata, Y; Kakimoto, K; Kii, T; Kojima, Y; Ota, K; Ozaki, H; Sugawara, N; Takeuchi, T; Terazawa, T; Yamaguchi, T, 2019)
" The frequency and severity of these adverse events vary from patient to patient and are partially explained by genetic polymorphism into the dihydropyrimidine dehydrogenase (DPYD) gene."	1.46	Fluoropyrimidine-Associated Toxicity in Two Gastrointestinal Cancer Patients: Potential Role of Common DPYD Polymorphisms. ( Cergnul, M; Cheli, S; Falvella, FS; Fava, S; Luoni, M, 2017)
"5-Fluorouracil (5-FU) has long been used for the treatment of gastrointestinal tumors harboring interindividual variability in both the pharmacokinetic and the pharmacogenetic profiles, which in turn may lead to life-threatening toxicities."	1.46	Prediction of severe toxicity in adult patients under treatment with 5-fluorouracil: a prospective cohort study. ( Angriman, F; Belloso, WH; Díaz de Arce, H; Jáuregui, EG; Minatta, JN; Orlova, M; Pallotta, MG; Scibona, P; Vázquez, C; Verzura, MA, 2017)
"These results reveal that distal hypesthesia occurring under treatment with oxaliplatin is markedly pronounced in the fingertips; however, as thermal threshold is unknown before treatment, it is difficult to assert that fingertip thermal hypesthesia has developed under treatment."	1.46	Quantification of Chronic Oxaliplatin-Induced Hypesthesia in Two Areas of the Hand. ( Andriamamonjy, M; Beaussier, H; Coudoré, F; Delmotte, JB; Savinelli, F, 2017)
"Depression was directly affected by fatigue (β=."	1.43	[Effect of Cancer Symptoms and Fatigue on Chemotherapy-related Cognitive Impairment and Depression in People with Gastrointestinal Cancer]. ( Lee, JR; Oh, PJ, 2016)
"To explore the clinical efficacy and toxic and side effects of recombinant human endostatin (rh- endostatin/endostar) combined with chemotherapy in the treatment of advanced gastric cancer."	1.42	Clinical observation on recombinant human endostatin combined with chemotherapy for advanced gastrointestinal cancer. ( Gao, SR; Li, LM; Wang, AR; Wang, GM; Xia, HP; Xu, HY, 2015)
"Of the 7 carcinoid tumors, 2 had partial response, and 2 had stable disease."	1.40	Efficacy of capecitabine and temozolomide combination in well-differentiated neuroendocrine tumors: Jordan experience. ( Abbasi, S; Albaba, H; Kashashna, A, 2014)
" Recently, improved outcomes in colorectal cancer patients due to pharmacokinetically guided 5-FU dosing were reported."	1.39	Comparative evaluation of the My5-FU™ immunoassay and LC-MS/MS in monitoring the 5-fluorouracil plasma levels in cancer patients. ( Aebi, Y; Büchel, B; Joerger, M; Largiadèr, CR; Schürch, S; Sistonen, J, 2013)
"First, HCT116 human colon cancer cells were cultured with PSK and 5-fluorouracil (5-FU) or 5'-deoxy-5-fluorouridine (5'-DFUR) in the presence or absence of PBMCs, and the antiproliferative effects were compared."	1.39	Protein-bound polysaccharide-K augments the anticancer effect of fluoropyrimidine derivatives possibly by lowering dihydropyrimidine dehydrogenase expression in gastrointestinal cancers. ( Abe, H; Edamatsu, T; Fujieda, A; Fujioka, M; Mekata, E; Murata, S; Naka, S; Shimizu, T; Shiomi, H; Sonoda, H; Tani, T; Umeda, T; Wada, T; Yamamoto, H, 2013)
" Intraperitoneal FU exposure (AUC) after IP treatment was >1000-fold plasma AUC after IP treatment (regional pharmacokinetic advantage), and >100-fold plasma AUC after intravenous treatment (regional therapeutic advantage)."	1.35	A feasibility, pharmacokinetic and frequency-escalation trial of intraperitoneal chemotherapy in high risk gastrointestinal tract cancer. ( Brown, CB; Chester, JD; Dunham, R; Farrugia, D; Finan, PJ; Halstead, F; Joel, SP; King, J; Seymour, MT; Slevin, ML; Trigonis, I; Wilson, G, 2008)
"Treatment with the combination of (177)Lu-octreotate and capecitabine was feasible and safe considering acute and subacute side effects."	1.35	Report on short-term side effects of treatments with 177Lu-octreotate in combination with capecitabine in seven patients with gastroenteropancreatic neuroendocrine tumours. ( de Herder, WW; Kam, BL; Krenning, EP; Kwekkeboom, DJ; van Aken, MO; van Essen, M, 2008)
"This article describes a woman with metastatic upper gastrointestinal cancer who developed thoracic myelopathy unexpectedly after standard dosage and fractionation radiotherapy."	1.33	Myelopathy after radiation therapy and chemotherapy with capecitabine and gemcitabine. ( Barstis, JL; Black, AC, 2005)
" Our objectives were to avoid severe 5-FU toxicities in patients with greatly impaired 5-FU and 5-FDHU pharmacokinetics after the administration of a reduced test dose of 5-FU and to investigate possible 5-FU or 5-FDHU pharmacokinetic parameters of the test dose related to the most common drug toxicities that affect patients after the first cycle of 5-FU chemotherapy."	1.33	A pharmacokinetic-based test to prevent severe 5-fluorouracil toxicity. ( Allegrini, G; Barbara, C; Barsanti, G; Bocci, G; Danesi, R; Del Tacca, M; Di Paolo, A; Falcone, A; Melosi, A; Vannozzi, F, 2006)
"Capecitabine was interrupted, discontinued or given at an adjusted dose in 13 (15%) patients because of acute toxicity."	1.33	Concurrent capecitabine and upper abdominal radiation therapy is well tolerated. ( Abbruzzese, JL; Baschnagel, A; Crane, CH; Das, P; Delclos, ME; Evans, DB; Janjan, NA; Krishnan, S; Varadhachary, GR; Vauthey, JN; Wolff, RA, 2006)
" The effects of 18 covariables on pharmacokinetic parameters were also studied in a univariate correlation analysis."	1.32	Extensive hepatic replacement due to liver metastases has no effect on 5-fluorouracil pharmacokinetics. ( De Vries, EG; Groen, HJ; Maring, JG; Piersma, H; Uges, DR; van Dalen, A, 2003)
" However, only a few pharmacokinetic data of 5-FU during chronomodulated infusion are available but up to now not for oxaliplatin."	1.32	Pharmacokinetics of oxaliplatin during chronomodulated infusion in metastatic gastrointestinal cancer patients: a pilot investigation with preliminary results. ( Höffken, K; Hoffmann, A; Merkel, U; Roskos, M; Wedding, U, 2003)
"Mitomycin and cisplatin were highly effective to prevent peritoneal carcinomatosis (direct application immediately after tumor cell transfer - 1 (st) treatment group)."	1.32	[Five cytostatic substances in animal studies for prevention and treatment of experimentally induced peritoneal carcinomatosis]. ( Fenske, A; Hribaschek, A; Krüger, S; Lippert, H; Meyer, F; Pross, M; Ridwelski, K, 2004)
"A survey of cancer treatment in a sample of hospitals > 100 beds conducted in 1998 compared with experience in the US showed that good progress has been achieved in Japan in the screening and early treatment of gastric cancer, and that the prognosis for breast cancer is better than in the West."	1.31	[Development of molecular targeting drugs for the treatment of cancer-therapeutic potential and issues to be addressed in global development]. ( Aiba, K; Akaza, H; Blackledge, G; Hinotsu, S; Isonishi, S; Kono, S; Mikami, O; Noguchi, S; Ogawa, O; Shibuya, M; Sone, S; Stribling, D; Tsuruo, T; Vose, B, 2000)
"A malignant carcinoid syndrome was present in 8 patients."	1.31	[Surgical and adjuvant therapy of neuroendocrine tumors of the gastrointestinal tract and their metastases. A retrospective analysis of personal patient group]. ( Hallfeldt, KK; Jückstock, H; Ladurner, R; Mussack, T; Schmidbauer, S; Trupka, AW, 2001)
"5-Fluorouracil (5-FU) is a commonly used chemotherapeutic agent."	1.31	A case of neurotoxicity following 5-fluorouracil-based chemotherapy. ( Han, CJ; Hong, YJ; Jeong, JM; Jeong, SH; Ki, SS; Kim, SH; Kim, YC; Lee, JH; Lee, JO, 2002)
"5-Fluorouracil is an S-phase-specific, synthetic pyrimidine antimetabolite, which is used as a cytostatic agent for a variety of malignant lesions, either singly or in multidrug regimens."	1.30	Supraventricular arrhythmia: a complication of 5-fluorouracil therapy. ( Ahmad, M; Aziz, SA; Iqbal, K; Jalal, S; Mohi-ud-Din, K; Tramboo, NA, 1998)
"In group 3, invasive squamous cell carcinoma and adenocarcinoma developed in one rat each."	1.30	Effect of 5-fluorouracil on gastrointestinal carcinogenesis induced by N-methyl-N'-nitro-N-nitrosoguanidine in rats. ( Mori, M; Muto, T; Nagawa, H; Seto, Y; Tsuruo, T, 1999)
" A tolerable dosage regimen was radiation at 45 Gy with 4 days of 5-FU plus leucovorin during the first week and 3 days during the last week with postradiation chemotherapy."	1.29	Early evaluation of combined fluorouracil and leucovorin as a radiation enhancer for locally unresectable, residual, or recurrent gastrointestinal carcinoma. The North Central Cancer Treatment Group. ( Burch, PA; Cha, SS; Gunderson, LL; Mailliard, JA; Martenson, JA; McKenna, PJ; Moertel, CG, 1994)
"In seven patients with advanced primary hepatocellular carcinoma the same therapeutic regime was used."	1.28	Hepatic chemoinfusion of 5-FU in metastasis of gastrointestinal cancer and advanced primary hepatocellular carcinoma. ( Cuan-Orozco, F; Kalk, JF; Koussouris, P; Mercado, MA; Paquet, KJ; Siemens, F, 1992)
" In the present study the pharmacokinetic behavior of 5-FU was investigated in combination with interferon alfa (IFN-alpha-2b) and further after adding the second well-established biomodulating agent folinic acid (FA)."	1.28	Influence of interferon alfa-2b with or without folinic acid on pharmacokinetics of fluorouracil. ( Czejka, MJ; Fogl, U; Jäger, W; Micksche, M; Schernthaner, G; Schüller, J, 1992)
"However, stomatitis is one of the limiting side effects."	1.28	Treatment of 5-fluorouracil-induced stomatitis by allopurinol mouthwashes. ( Elzawawy, A, 1991)
"5-Fluorouracil was given on postoperative days 2-5 at 15 and 20 mg/kg, respectively."	1.28	Early postoperative intraperitoneal chemotherapy as an adjuvant therapy to surgery for peritoneal carcinomatosis from gastrointestinal cancer: pharmacological studies. ( Cunliffe, WJ; DeBruijn, EA; Graves, T; Hull, WE; Mullins, RE; Oliff, L; Schlag, P; Sugarbaker, PH, 1990)
"The cases of primary hepatic cancer are 2 cases of hepatoma (413, 420 days) and 1 case of cancer of bile-duct (400 days)."	1.28	[Evaluation of long survival cases treated with intra-arterial cancer chemotherapy using implantable reservoirs]. ( Katsuki, Y; Nishimura, A; Tsuji, Y; Yasuda, T, 1989)
" When IHAI chemotherapy was combined with hyperthermic treatment, antitumor effects were generated in 3 of 6 metastatic patients from colorectal cancer, who had received no benefit from the IHAI chemotherapy alone."	1.28	[Intra-hepato-arterial chemotherapy combined with hyperthermic treatment: clinical results of metastatic cancer of the liver and effects on correct (but not at all necessary) hepatic blood flow]. ( Hamazoe, R; Inoue, Y; Koga, S; Maeta, M; Murakami, A; Shabana, M, 1989)
"Although both patients with hepatocellular cancer and the patient with a soft tissue sarcoma responded to the regimen, only 1 of 38 patients with adenocarcinoma had a favourable response."	1.27	Adriamycin, CCNU, and 5-fluorouracil in patients with advanced gastrointestinal cancer. ( Cedermark, BJ; Gunven, P; Hammarberg, C, 1983)
"One partial remission out of 7 cases of stomach cancer was obtained, and its duration was 40 weeks."	1.27	[Clinical trial on the effect of tegafur (SF-SP)]. ( Akazawa, S; Futatsuki, K; Hattori, M; Ishibashi, I; Kanda, Y; Sendai, H; Shimada, S, 1984)
"Uridine was also examined for its effect on 5-fluorouracil toxicity in two patients."	1.27	Phase I and pharmacokinetic studies of high-dose uridine intended for rescue from 5-fluorouracil toxicity. ( Gall, H; Kraal, I; Lankelma, J; Leyva, A; Peters, GJ; Pinedo, HM; van Groeningen, CJ, 1984)
" Reduced clearance of FU by MISO was associated with an earlier onset of the period of nonlinearity of FU pharmacokinetics and an increased half-life of elimination."	1.27	Pharmacokinetic rationale for the interaction of 5-fluorouracil and misonidazole in humans. ( Martin, WM; McDermott, BJ; Murphy, RF; Van den Berg, HW, 1983)
"5-Fluorouracil (5-Fu) was administered by a constant venous infusion schedule at a dose of 300 mg/m2/d for 30-180 days."	1.27	Protracted ambulatory venous infusion of 5-fluorouracil. ( Bothe, A; Fine, N; Lokich, J; Perri, J, 1983)
" This allows an examination of dose-response relationships and comparisons of therapeutic index."	1.27	Comparison of unique leucovorin and 5-fluorouracil "escalating" and "maximum" dosage strategies. ( Bruckner, HW; Mayer, R; Novak, J; Petrelli, NJ; Stablein, D, 1987)
" Toxic effects are specially considered in this paper, where effects in 20 advanced gastrointestinal patients are evaluated."	1.27	[5-fluorouracil in high doses. Principles and toxicity]. ( Fleischer, I; Milano, MC; Wainstein, R, 1985)
" The pharmacologic properties of FT appear to dictate its most useful schedule (continuous oral dosing in multiple doses) and explain why FT alone is not ideal as a 5-FU pro-drug."	1.27	Relevance of the pharmacology of oral tegafur to its use as a 5-FU pro-drug. ( Byfield, JE; Frankel, SS; Griffiths, JC; Hornbeck, CL; Sharp, TR, 1985)
"Phosphorylating activity in squamous cell carcinoma of the lung was similar to that in adenocarcinomas."	1.26	Metabolism of 5-fluorouracil in various human normal and tumor tissues. ( Fujii, S; Maehara, Y; Nagayama, S; Nakamura, H; Okazaki, H; Shirasaka, T, 1981)
"Patients with hepatic metastases have 5-FU TBCs about half that of those found in patients without hepatic involvement."	1.26	Clearance of continuously infused 5-fluorouracil in adults having lung or gastrointestinal carcinoma with or without hepatic metastases. ( Byfield, JE; Floyd, RA; Frankel, SS; Griffiths, JC; Hornbeck, CL, 1982)
"Stomach cancer and colorectal cancer showed partial responses in 10."	1.26	[Phase II study of a new fluorinated pyrimidine, ethyl (+/-)-t-6-butoxy-5-fluoro-2, 4-dioxohexahydropyrimidine-r-5-carboxylate (TAC-278)]. ( , 1982)
"Twenty-three cases of cancer patients were treated with FT-207 alone orally more than 52 weeks up to 199 weeks continuously with daily dose of 600-800mg with capsules, and 600-1200mg with enteric coated capsules, except one case with markedly light body weight (28kg)."	1.26	[Toxic effects of prolonged oral administration of tegafur (FT-207)]. ( Majima, H; Nishimura, A, 1982)
"The frequency of cells with chromosome aberrations in the lymphocyte culture of the patients before the treatment was significantly higher than that in the healthy donors."	1.26	[Cytogenetic studies of the effects of 5-fluorouracil in vivo]. ( Akulenko, TV, 1981)
"Less than 20% of advanced colorectal cancers respond to chemotherapy."	1.26	Chemotherapy for gastrointestinal malignancy. ( Balint, JA; Van der Veer, LD, 1980)
"Gastrointestinal cancer has proved exceedingly resistant to chemotherapy efforts."	1.26	[Chemotherapy of gastrointestinal cancer (author's transl)]. ( Gropp, C; Havemann, K, 1978)
" Its applications to the pharmacokinetic study of unchanged 5-Fluorouracil in man following an intravenous bolus, 8 hours infusion and oral administration confirmed the non-linearity of the kinetic model."	1.26	Determination of 5-fluorouracil in plasma by GC/MS using an internal standard. Applications to pharmacokinetics. ( Aubert, C; Cano, JP; Carcassonne, Y; Rigault, JP; Seitz, JF, 1979)
"The therapy of cancer of the colon still remains unsatisfactory: the rate of remissions could be increased, but survival remains unaltered."	1.26	[Current state of therapy for gastrointestinal tumors]. ( Hartmann, D; Obrecht, JP, 1978)
"Although advanced gastrointestinal cancer is the most commonplace problem encountered by the medical oncologist, this group of diseases has proved exceedingly resistant to past chemotherapy efforts."	1.25	Clinical management of advanced gastrointestinal cancer. ( Moertel, CG, 1975)
"All 14 patients with breast carcinoma underwent remission and in 6 this was complete."	1.25	Seventy-five cases of solid tumours treated by a modified quadruple chemotherapy regime. ( Hanham, IW; Newton, KA; Westbury, G, 1971)

Research

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Authors

Clinical Trials (21)

Trial Overview

Trial Outcomes

6 Month Progression Free Survival (PFS)

Timeframe	Studies, this research(%)	All Research%
pre-1990	243 (45.34)	18.7374
1990's	99 (18.47)	18.2507
2000's	83 (15.49)	29.6817
2010's	84 (15.67)	24.3611
2020's	27 (5.04)	2.80

Authors	Studies
Bloor, S	1
Catchpole, O	1
Mitchell, K	1
Webby, R	1
Davis, P	1
Helsby, N	1
Burns, K	1
Findlay, M	2
Porter, D	1
Strother, M	1
Riera, P	1
Riba, M	1
Bernal, S	1
Virgili, AC	1
Páez, D	1
Moreno, ME	1
Fedorinov, DS	1
Lyadov, VK	1
Sychev, DA	1
Bruckner, HW	5
Bassali, F	1
Dusowitz, E	1
Gurell, D	1
Book, A	1
De Jager, R	1
Kasi, A	1
Gaudel, P	1
Lekkala, M	1
Al-Rajabi, R	1
Saeed, A	1
Sun, W	3
Porter, C	1
Lau, DK	1
Fong, C	1
Arouri, F	1
Cortez, L	1
Katifi, H	1
Gonzalez-Exposito, R	1
Razzaq, MB	1
Li, S	1
Macklin-Doherty, A	1
Hernandez, MA	2
Hubank, M	1
Fribbens, C	1
Watkins, D	2
Rao, S	2
Chau, I	3
Cunningham, D	9
Starling, N	2
Iimura, Y	2
Kurokawa, T	1
Nojima, M	1
Kanemoto, Y	1
Yazawa, K	1
Tsurita, G	1
Kuroda, S	2
Yasu, T	1
Momo, K	1
Hough, NE	1
Chapman, SJ	1
Flight, WG	1
Luo, D	1
Wang, L	1
Chen, X	1
Xiong, Y	1
Yi, F	1
Ding, J	1
Ding, H	1
Wei, Y	1
Zhang, W	1
Jacob, J	1
Mathew, SK	1
Chacko, RT	1
Aruldhas, BW	1
Singh, A	1
Prabha, R	1
Mathew, BS	1
Merola, E	1
Dal Buono, A	1
Denecke, T	1
Arsenic, R	1
Pape, UF	1
Jann, H	1
Wiedenmann, B	1
Pavel, ME	1
Maeda, O	1
Shimokata, T	1
Ando, Y	1
Sharma, MR	1
Joshi, SS	1
Kindler, HL	1
Draper, AS	1
Lafollette, J	1
Kim, C	1
Wu, CS	1
Sugiyama, K	1
Shiraishi, K	1
Sato, M	1
Nishibori, R	1
Nozawa, K	1
Kitagawa, C	1
Teng, C	1
Reuter, SE	1
Blinman, PL	1
Dhillon, HM	1
Galettis, P	1
Proschogo, N	1
McLachlan, AJ	1
Vardy, JL	1
Tron, C	1
Lemaitre, F	1
Boisteau, E	1
Sourd, SL	1
Lièvre, A	1
Kayahan, N	1
Karaca, M	1
Satış, H	1
Yapar, D	1
Özet, A	1
Visacri, MB	1
Duarte, NC	1
Lima, TM	1
de Souza, RN	1
Cobaxo, TS	1
Teixeira, JC	1
Barbosa, CR	1
Dias, LP	1
Tavares, MG	1
Pincinato, EC	1
Lima, CS	1
Moriel, P	1
Quinonero, F	1
Cepero, A	1
Urbano, D	1
Munoz-Gamez, JA	1
Martin-Guerrero, SM	1
Martin-Oliva, D	1
Prados, J	1
Melguizo, C	1
Ortiz, R	1
Khushman, M	2
Patel, GK	2
Maharjan, AS	2
McMillin, GA	2
Nelson, C	2
Hosein, P	1
Singh, AP	2
Arafat, M	1
Song, Y	1
Brewer, K	1
Fouladian, P	1
Parikh, A	1
Albrecht, H	1
Blencowe, A	1
Garg, S	1
Machover, D	3
Almohamad, W	1
Castagné, V	1
Desterke, C	1
Gomez, L	1
Gaston-Mathé, Y	1
Boucheix, C	1
Goldschmidt, E	3
Gratiaux, J	1
Gossery, C	1
Rezzag-Mahcene, C	1
Botsen, D	1
Visseaux, L	1
Slimano, F	1
Bouche, O	1
Fernandes, MR	1
Rodrigues, JCG	1
Dobbin, EAF	1
Pastana, LF	1
da Costa, DF	1
Barra, WF	1
Modesto, AAC	1
de Assumpção, PB	1
da Costa Silva, AL	1
Dos Santos, SEB	1
Burbano, RMR	1
de Assumpção, PP	1
Dos Santos, NPC	1
Peixoto, RD	1
Coutinho, AK	1
Weschenfelder, RF	1
Prolla, G	1
Rocha, D	1
Andrade, AC	1
Rego, JF	1
Fernandes, GDS	1
Crosara, M	1
Hoff, PM	1
Dienstmann, R	1
Costa E Silva, M	1
Riechelmann, RP	1
Hernando-Cubero, J	1
Matos-García, I	1
Alonso-Orduña, V	1
Capdevila, J	1
Falvella, FS	1
Luoni, M	1
Cheli, S	1
Fava, S	1
Cergnul, M	1
Vázquez, C	1
Orlova, M	1
Angriman, F	1
Minatta, JN	1
Scibona, P	1
Verzura, MA	1
Jáuregui, EG	1
Díaz de Arce, H	1
Pallotta, MG	1
Belloso, WH	1
Konno, M	2
Matsui, H	1
Koseki, J	1
Asai, A	2
Kano, Y	1
Kawamoto, K	2
Nishida, N	2
Sakai, D	1
Kudo, T	2
Satoh, T	3
Doki, Y	2
Mori, M	3
Ishii, H	2
Ettrich, TJ	1
Ebert, M	1
Lorenzen, S	1
Moehler, M	1
Vogel, A	1
Witkowski, L	1
Seufferlein, T	1
Reinacher-Schick, A	1
Peeters, M	2
Cervantes, A	1
Moreno Vera, S	1
Taieb, J	2
Traylor, M	1
Walker, JL	1
Corrigan, AA	1
Newhouse, SJ	1
Folarin, AA	1
Patel, H	1
Ross, PJ	3
Sanderson, JD	1
Spicer, J	1
Prescott, NJ	1
Mathew, CG	1
Marinaki, AM	1
Lewis, CM	1
Zhong, L	1
Fu, Q	1
Zhou, S	1
Chen, L	2
Peng, Q	1
Harding, JJ	1
Do, RK	1
Dika, IE	1
Hollywood, E	1
Uhlitskykh, K	1
Valentino, E	1
Wan, P	1
Hamilton, C	1
Feng, X	1
Johnston, A	1
Bomalaski, J	1
Li, CF	1
O'Reilly, EM	1
Abou-Alfa, GK	1
Akin, S	1
Kas Guner, C	1
Khan, K	1
Rane, JK	1
Kalaitzaki, E	1
Forster, M	1
Braconi, C	1
Valeri, N	1
Gerlinger, M	1
Boilève, A	1
Wicker, C	1
Verret, B	1
Leroy, F	1
Malka, D	2
Jozwiak, M	1
Pontoizeau, C	1
Ottolenghi, C	1
De Lonlay, P	1
Ducreux, M	2
Hollebecque, A	1
Yukami, H	1
Terazawa, T	2
Goto, M	3
Aoki, M	1
Asaishi, K	1
Yamaguchi, T	3
Kuwakado, S	1
Kii, T	2
Higuchi, K	2
Ota, K	1
Takeuchi, T	1
Kojima, Y	1
Harada, S	1
Ozaki, H	1
Sugawara, N	1
Hirata, Y	1
Kakimoto, K	1
Macaire, P	1
Morawska, K	1
Vincent, J	1
Quipourt, V	1
Marilier, S	1
Ghiringhelli, F	1
Bengrine-Lefevre, L	2
Schmitt, A	1
Awan, S	1
Taylor, WR	1
Pai, S	1
Frankel, AE	1
Wang, B	1
Hosein, PJ	1
Büchel, B	2
Sistonen, J	1
Joerger, M	3
Aebi, Y	1
Schürch, S	2
Largiadèr, CR	2
Aprile, G	1
Lutrino, SE	1
Sobrero, A	1
Roselli, M	1
Ferroni, P	1
Rolfo, C	1
Palmirotta, R	1
Formica, V	1
Ludovici, G	1
Laudisi, A	1
De Marchis, ML	1
La Farina, F	1
Russo, A	1
Guadagni, F	1
Ilhan-Mutlu, A	1
Preusser, M	1
Schoppmann, SF	1
Asari, R	1
Ba-Ssalamah, A	1
Schwameis, K	1
Pluschnig, U	1
Birner, P	1
Püspök, A	1
Zacherl, J	1
Hejna, M	1
Mekata, E	1
Murata, S	1
Sonoda, H	1
Shimizu, T	1
Umeda, T	1
Shiomi, H	1
Naka, S	1
Yamamoto, H	1
Abe, H	1
Edamatsu, T	1
Fujieda, A	1
Fujioka, M	1
Wada, T	1
Tani, T	1
Cunha-Junior, GF	2
De Marco, L	1
Bastos-Rodrigues, L	1
Bolina, MB	1
Martins, FL	1
Pianetti, GA	2
Cesar, IC	2
Coelho, LG	1
Duffy, AG	1
Greten, TF	1
Zhang, X	2
Cao, C	2
Zhang, Q	1
Chen, Y	4
Gu, D	2
Shen, Y	1
Gong, Y	1
Chen, J	2
Tang, C	2
Hoh, CK	1
Burris, HA	1
Bendell, JC	1
Tarazi, J	1
Rosbrook, B	1
Kim, S	1
Infante, JR	1
Reid, TR	2
Meyer, T	1
Qian, W	1
Caplin, ME	1
Armstrong, G	1
Lao-Sirieix, SH	1
Hardy, R	1
Valle, JW	2
Talbot, DC	1
Reed, N	1
Shaw, A	1
Navalkissoor, S	1
Luong, TV	1
Corrie, PG	1
Han, NY	1
Park, BJ	1
Sung, DJ	1
Kim, MJ	1
Cho, SB	1
Lee, CH	1
Jang, YJ	1
Kim, SY	1
Kim, DS	1
Um, SH	1
Won, NH	1
Yang, KS	1
Takahashi, N	2
Aoyama, F	1
Hiyoshi, M	1
Kataoka, H	1
Sawaguchi, A	1
Miger, J	1
Holmqvist, A	1
Sun, XF	1
Albertsson, M	1
Hong, L	1
Han, Y	1
Yang, J	2
Zhang, H	1
Zhao, Q	1
Wu, K	1
Fan, D	1
Kuang, M	1
He, M	1
Machida, N	1
Morizane, C	1
Kasuga, A	1
Takahashi, H	3
Sudo, K	1
Nishina, T	1
Tobimatsu, K	1
Ishido, K	1
Furuse, J	1
Boku, N	2
Okusaka, T	1
Huang, L	1
Chen, F	1
Yang, X	1
Xu, S	1
Ge, S	1
Fu, S	1
Chao, T	1
Yu, Q	1
Liao, X	1
Hu, G	1
Zhang, P	1
Yuan, X	1
Abbasi, S	1
Kashashna, A	1
Albaba, H	1
Mitry, E	2
Walter, T	2
Baudin, E	2
Kurtz, JE	1
Ruszniewski, P	1
Dominguez-Tinajero, S	1
Cadiot, G	1
Dromain, C	2
Farace, F	1
Rougier, P	2
Huitema, AD	1
Boot, H	1
Cats, A	1
Doodeman, VD	1
Smits, PH	1
Vainchtein, L	1
Rosing, H	1
Meijerman, I	1
Zueger, M	1
Meulendijks, D	1
Cerny, TD	1
Beijnen, JH	1
Schellens, JH	1
Yan, Y	1
Mo, Y	1
Zhang, D	1
Gao, SR	1
Li, LM	1
Xia, HP	1
Wang, GM	1
Xu, HY	1
Wang, AR	1
Li, B	1
Liu, Y	1
Wang, J	1
Xu, D	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Develop and Evaluate the Effectiveness of a Self-Care Smartphone Application on the Self-Efficacy, and Resilience Among Newly Diagnosed Breast Cancer Patients Undergoing Treatment[NCT05576545]		73 participants (Actual)	Interventional	2020-09-18	Completed
A Pilot Study of Combined Immune Checkpoint Inhibition in Combination With Ablative Therapies in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC)[NCT02821754]	Phase 2	54 participants (Actual)	Interventional	2016-07-05	Completed
A Randomized Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Combinations With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer Preceded By A Phase 1 Portion[NCT00460603]	Phase 1/Phase 2	187 participants (Actual)	Interventional	2006-01-31	Completed
Discovery and Validate of Multi-genetic Biomarkers for Capecitabine in Chinese Colorectal Patients[NCT03030508]		300 participants (Anticipated)	Observational	2016-01-31	Enrolling by invitation
A Phase II, Randomised Controlled Trial to Evaluate the Efficacy and Safety of Moisturising Creams With or Without Palm-oil-derived Vitamin E Concentrate in Addition to Urea-based Cream or Urea-based Cream Alone in Capecitabine-associated Palmar-Plantar E[NCT05939726]		90 participants (Anticipated)	Interventional	2023-05-16	Recruiting
A Randomized, Open-label Phase III Trial of Mapisal® Versus an Urea Hand-foot Cream as Prophylaxis for Capecitabine-induced Hand-foot Syndrome in Patients With Gastrointestinal Tumors or Breast Cancer[NCT01626781]		0 participants	Expanded Access		No longer available
A Phase I Clinical Trial of Sequential Pralatrexate Followed by a 48-hour Infusion of 5- Fluorouracil Given Every Other Week in Adult Patients With Solid Tumors[NCT01206465]	Phase 1	29 participants (Actual)	Interventional	2010-09-14	Completed
Prevention of Post-sphincterotomy Bleeding by Endoscopic Tranexamic Acid and Sucralfate Administration: A Randomized Controlled Trial[NCT06107504]		60 participants (Anticipated)	Interventional	2023-11-01	Not yet recruiting
Precise Administration of Sucralfate Powder in Prevention of Delayed Polypectomy Bleeding: a Randomized Clinical Trial[NCT05817656]	Phase 1	160 participants (Anticipated)	Interventional	2023-05-15	Recruiting
Pilot Study of Hepatic Arterial Infusion Therapy in Patients With Unresectable or Borderline Resectable Intrahepatic Cholangiocarcinoma[NCT01525069]	Phase 1	27 participants (Actual)	Interventional	2012-04-03	Terminated (stopped due to Equipment that was used in the study was discontinued)
Phase I Clinical Study of Every Three Week Irinotecan With Oral Capecitabine Given Twice Daily for Two Weeks Out of Three in Patients With Gastrointestinal and Other Solid Malignancies[NCT00003867]	Phase 1	30 participants (Actual)	Interventional	1999-03-31	Completed
Microvascular Function in Patients Undergoing 5-Fluorouracil Chemotherapy[NCT04042298]		106 participants (Anticipated)	Observational	2019-06-25	Recruiting
A Non-Interventional Prospective Study of the Correlation of the Precision Therapeutics, Inc. Chemoresponse Assay With Progression-Free Survival in Patients With Recurrent Epithelial Ovarian, Peritoneal, or Fallopian Tube Cancer.[NCT00288275]		256 participants (Anticipated)	Observational	2004-07-31	Terminated
ChemoFx® PRO - A Post-Market Data Collection Study Utilizing Physician Reported Outcomes[NCT00669422]		2,756 participants (Actual)	Observational	2006-10-31	Terminated
A Phase II Trial to Analyze Clinical and Pharmacological Properties for Severe Neutropenia After Cytoreductive Surgery Followed by Hyperthermic Intraperitoneal Chemotherapy Using Mitomycin-C[NCT05513183]		74 participants (Actual)	Observational	2021-05-20	Completed
Efficacy of the Oncoxin-Viusid® Nutritional Supplement on the Quality of Life of Patients With Advanced or Metastatic Ovarian Epithelial Cancer. Clinical Trial Phase II.[NCT03562897]	Phase 2	40 participants (Actual)	Interventional	2018-10-25	Completed
A Phase I Study of S-1 in Combination With Radiotherapy in Locally Advanced or Recurrent Gastric Cancer[NCT01291407]	Phase 1	27 participants (Actual)	Interventional	2010-11-30	Completed
Technical Feasibility of Modified Early Post-Operative Intraperitoneal Chemotherapy (mEPIC)[NCT05913674]	Phase 2	25 participants (Anticipated)	Interventional	2023-07-31	Not yet recruiting
Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Escalating Dose I.P. Platinum for Gastrointestinal Peritoneal Carcinomatosis[NCT00001332]	Phase 1	50 participants	Interventional	1992-12-31	Completed
A Pilot Study of Immune Checkpoint Inhibition (Durvalumab With or Without Tremelimumab) in Combination With Radiation Therapy in Patients With Unresectable Pancreatic Cancer[NCT02311361]	Phase 1/Phase 2	65 participants (Actual)	Interventional	2015-03-25	Completed
Phase III Trial of S-1 and Cisplatin (3 Weekly) Versus S-1 and Oxaliplatin Combination Chemotherapy for First Line Treatment of Advanced Gastric Cancer[NCT01671449]	Phase 3	338 participants (Actual)	Interventional	2012-12-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

PFS is the median amount of time subject survives without disease progression 6 months after treatment. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. (NCT02821754)
Timeframe: At 6 months

Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

Intervention	Months (Median)
Radiofrequency Ablation/Trans-arterial Catheter Chemoembolization (RFA/TACE)	2.8
Radiofrequency Ablation/Cryoablation (RFA/CA)	NA

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT02821754)
Timeframe: Date treatment consent signed to date off study, approximately 62 months and 3 days for the RFA/TACE group, and 27 months and 24 days for the RFA/CA group.

Number of Grades 1-5 Adverse Events Related to Tremelimumab and Durvalumab

Intervention	Participants (Count of Participants)
Radiofrequency Ablation/Trans-arterial Catheter Chemoembolization (RFA/TACE)	36
Radiofrequency Ablation/Cryoablation (RFA/CA)	16

Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE)v4.0. Grade 1 is mild, grade 2 is moderate, grade 3 is severe, grade 4 is life-threatening, and grade 5 is death related to adverse event. (NCT02821754)
Timeframe: 60 days after last treatment, an average of 44.89 months

Duration of Response (DR): Phase 2

Intervention	adverse events (Number)
	Grade 1	Grade 2	Grade 3	Grade 4	Grade 5
Radiofrequency Ablation/Cryoablation (RFA/CA)	233	133	50	3	2
Radiofrequency Ablation/Trans-arterial Catheter Chemoembolization (RFA/TACE)	355	125	62	6	0

Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response. CR: disappearance of all lesions and no appearance of new lesions. PR: >=30% decrease in sum of LD of target lesions taking as reference the baseline sum LD, without progression of nontarget lesions and no appearance of new lesions. Progression: >=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation. (NCT00460603)
Timeframe: Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)

Overall Survival (OS): Phase 2

Intervention	days (Median)
Phase 2: Axitinib + FOLFOX	434.0
Phase 2: Bevacizumab + FOLFOX	NA
Phase 2: Axitinib + Bevacizumab + FOLFOX	343.0

Time in days from randomization date to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). (NCT00460603)
Timeframe: Every 3 months after discontinuation of study treatment until death due to any cause or 1 year after randomization of the last participant

Percentage of Participants With Objective Response: Phase 2

Intervention	days (Median)
Phase 2: Axitinib + FOLFOX	552.0
Phase 2: Bevacizumab + FOLFOX	659.0
Phase 2: Axitinib + Bevacizumab + FOLFOX	601.0

Percentage of participants with objective response (OR) based assessment of confirmed complete response(CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all lesions and no appearance of new lesions. Confirmed PR defined as >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as reference the baseline sum LD , without progression of nontarget lesions and no appearance of new lesions. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response. (NCT00460603)
Timeframe: Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)

Progression-Free Survival (PFS): Phase 2

Intervention	Percentage of participants (Number)
Phase 2: Axitinib + FOLFOX	28.6
Phase 2: Bevacizumab + FOLFOX	48.8
Phase 2: Axitinib + Bevacizumab + FOLFOX	39.0

"Time in days from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death). Progression: >=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation." (NCT00460603)
Timeframe: Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)

Time to Treatment Failure (TTF): Phase 2

Intervention	days (Median)
Phase 2: Axitinib + FOLFOX	336
Phase 2: Bevacizumab + FOLFOX	485
Phase 2: Axitinib + Bevacizumab + FOLFOX	381

TTF is defined as the time from the randomization to the date of the first documentation of PD, symptomatic deterioration, death due to any cause, or treatment discontinuation due to adverse event, refusal or other reasons. Progression: >=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation. (NCT00460603)
Timeframe: Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)

Apparent Oral Clearance (CL/F) For Axitinib: Phase 1

Intervention	days (Median)
Phase 2: Axitinib + FOLFOX	187.0
Phase 2: Bevacizumab + FOLFOX	241.0
Phase 2: Axitinib + Bevacizumab + FOLFOX	238.0

Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. CL/F for axitinib (AG-013736) in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. (NCT00460603)
Timeframe: Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1

Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For 5-Fluorouracil: Phase 1

Intervention	Liter per hour (L/hr) (Geometric Mean)
	Cycle 1 Day 8	Cycle 2 Day 1
Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)	30.01	30.08
Phase 1: Axitinib + FOLFIRI (Cohort 4)	47.10	33.33
Phase 1: Axitinib + FOLFOX (Cohort 5)	28.49	28.90

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. AUClast for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose. (NCT00460603)
Timeframe: Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1

Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Axitinib: Phase 1

Intervention	ng*hr/mL (Geometric Mean)
	Cycle 1 Day 1	Cycle 2 Day 1
Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)	39212.03	45087.71
Phase 1: Axitinib + FOLFIRI (Cohort 4)	40955.29	36533.84
Phase 1: Axitinib + FOLFOX (Cohort 5)	52164.28	95123.13

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Pharmacokinetic (PK) parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. AUClast for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose. (NCT00460603)
Timeframe: Predose, 1, 2, 2.5, 4, 6 and 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1

Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Bevacizumab: Phase 1

Intervention	nanogram hour per milliliter (ng*hr/mL) (Geometric Mean)
	Cycle 1 Day 8	Cycle 2 Day 1
Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)	119.02	95.70
Phase 1: Axitinib + FOLFIRI (Cohort 4)	106.76	143.68
Phase 1: Axitinib + FOLFOX (Cohort 5)	97.05	117.47

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. AUClast for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose. (NCT00460603)
Timeframe: Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1

Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Irinotecan: Phase 1

Intervention	ng*hr/mL (Geometric Mean)
	Cycle 1 Day 1	Cycle 2 Day 1
Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)	3394758.83	3554899.52

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). AUClast for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose. (NCT00460603)
Timeframe: Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1

Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Oxaliplatin: Phase 1

Intervention	ng*hr/mL (Geometric Mean)
	Cycle 1 Day 1	Cycle 2 Day 1
Phase 1: Axitinib + FOLFIRI (Cohort 4)	12081.58	11496.32

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. AUClast for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose. (NCT00460603)
Timeframe: Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For 5-Fluorouracil: Phase 1

Intervention	ng*hr/mL (Geometric Mean)
	Cycle 1 Day 1	Cycle 2 Day 1
Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)	4814.87	5231.71
Phase 1: Axitinib + FOLFOX (Cohort 5)	4308.71	5303.66

AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose. (NCT00460603)
Timeframe: Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Axitinib: Phase 1

Intervention	ng*hr/mL (Geometric Mean)
	Cycle 1 Day 1	Cycle 2 Day 1
Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)	36314.14	38983.80
Phase 1: Axitinib + FOLFIRI (Cohort 4)	41460.50	36776.79
Phase 1: Axitinib + FOLFOX (Cohort 5)	52430.15	96632.41

AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. AUC (t - ∞] for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose. (NCT00460603)
Timeframe: Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Bevacizumab: Phase 1

Intervention	ng*hr/mL (Geometric Mean)
	Cycle 1 Day 8	Cycle 2 Day 1
Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)	190.51	224.46
Phase 1: Axitinib + FOLFIRI (Cohort 4)	113.20	168.07
Phase 1: Axitinib + FOLFOX (Cohort 5)	205.41	178.46

AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose. (NCT00460603)
Timeframe: Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Irinotecan: Phase 1

Intervention	ng*hr/mL (Geometric Mean)
	Cycle 1 Day 1	Cycle 2 Day 1
Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)	4987528.96	5114888.84

AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose. (NCT00460603)
Timeframe: Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Oxaliplatin: Phase 1

Intervention	ng*hr/mL (Geometric Mean)
	Cycle 1 Day 1	Cycle 2 Day 1
Phase 1: Axitinib + FOLFIRI (Cohort 4)	13055.88	12459.89

AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose. (NCT00460603)
Timeframe: Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1

Change From Baseline in M.D. Anderson Symptom Assessment Inventory - Diarrhea (MDASI-D) Symptom Severity and Interference Subscale Scores at Day 1 of Cycle 2 Through Day 1 Cycle 42 and Follow-up: Phase 2

Intervention	ng*hr/mL (Geometric Mean)
	Cycle 1 Day 1	Cycle 2 Day 1
Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)	5955.70	6744.06
Phase 1: Axitinib + FOLFOX (Cohort 5)	5137.31	6430.67

"PROs included assessment of symptom severity and interference which were measured using M.D. Anderson Symptom Assessment Inventory-Diarrhea (MDASI-D), 20-item questionnaire which assesses the severity of 14 symptoms over the past 24 hours, as well as symptoms interference with 6 areas of function (e.g., walking, work, mood), when the symptom was at its worst. Each item is scored from 0 to 10, with '0' indicating that the symptom was either not present or did not interfere with their activities, and '10' indicating that the symptom was as bad as you can imagine or interfered completely with their life. The 2 subscales, symptom severity score and symptom interference score were average of respective items and ranged from 0 to 10, higher score indicating greater severity or interference of symptoms." (NCT00460603)
Timeframe: Cycle 1 Day 1 (baseline), every 2 weeks for the first 2 months (Cycle 2 Day 1 [C2D1], Cycle 3 Day 1, and Cycle 4 Day 1) then monthly thereafter starting Cycle 6 Day 1, and 28 days after the last dose

Clearance (CL) For 5-Fluorouracil: Phase 1

Intervention	units on scale (Mean)
	Severity Scale: Baseline (n=41,43,40)	Severity Scale: C2D1 (n=37,37,37)	Severity Scale: C3D1 (n=32,38,32)	Severity Scale: C4D1 (n=23,37,30)	Severity Scale: C5D1 (n=23,34,29)	Severity Scale: C6D1 (n=15,38,26)	Severity Scale: C7D1 (n=12,30,22)	Severity Scale: C8D1 (n=17,29,22)	Severity Scale: C9D1 (n=11,24,21)	Severity Scale: C10D1 (n=14,27,21)	Severity Scale: C11D1 (n=10,20,19)	Severity Scale: C12D1 (n=11,23,16)	Severity Scale: C13D1 (n=8,13,12)	Severity Scale: C14D1 (n=8,17,14)	Severity Scale: C15D1 (n=7,11,9)	Severity Scale: C16D1 (n=7,17,14)	Severity Scale: C17D1 (n=5,11,6)	Severity Scale: C18D1 (n=6,14,9)	Severity Scale: C19D1 (n=4,8,16)	Severity Scale: C20D1 (n=5,14,8)	Severity Scale: C21D1 (n=4,5,5)	Severity Scale: C22D1 (n=3,11,8)	Severity Scale: C23D1 (n=4,5,3)	Severity Scale: C24D1 (n=5,11,7)	Severity Scale: C25D1 (n=4,5,5)	Severity Scale: C26D1 (n=4,6,7)	Severity Scale: C27D1 (n=4,3,4)	Severity Scale: C28D1 (n=4,5,7)	Severity Scale: C29D1 (n=2,3,4)	Severity Scale: C30D1 (n=3,6,3)	Severity Scale: C31D1 (n=1,1,3)	Severity Scale: C32D1 (n=2,4,4)	Severity Scale: C33D1 (n=0,0,2)	Severity Scale: C34D1 (n=2,4,3)	Severity Scale: C35D1 (n=0,0,1)	Severity Scale: C36D1 (n=2,3,2)	Severity Scale: C37D1 (n=0,1,0)	Severity Scale: C38D1 (n=2,2,1)	Severity Scale: C39D1 (n=0,1,0)	Severity Scale: C40D1 (n=2,2,2)	Severity Scale: C42D1 (n=2,2,1)	Severity Scale: Follow_Up (n=4,15,14)	Interference Scale: Baseline (n=41,43,40)	Interference Scale: C2D1 (n=37,37,36)	Interference Scale: C3D1 (n=31,38,30)	Interference Scale: C4D1 (n=23,36,30)	Interference Scale: C5D1 (n=23,34,29)	Interference Scale: C6D1 (n=15,38,26)	Interference Scale: C7D1 (n=12,30,22)	Interference Scale: C8D1 (n=17,29,22)	Interference Scale: C9D1 (n=11,24,21)	Interference Scale: C10D1 (n=14,27,21)	Interference Scale: C11D1 (n=10,20,19)	Interference Scale: C12D1 (n=10,23,16)	Interference Scale: C13D1 (n=8,13,12)	Interference Scale: C14D1 (n=8,17,14)	Interference Scale: C15D1 (n=7,11,9)	Interference Scale: C16D1 (n=7,17,14)	Interference Scale: C17D1 (n=5,11,6)	Interference Scale: C18D1 (n=6,14,9)	Interference Scale: C19D1 (n=4,8,6)	Interference Scale: C20D1 (n=5,14,8)	Interference Scale: C21D1 (n=4,5,5)
Phase 2: Axitinib + Bevacizumab + FOLFOX	2.18	0.80	0.63	0.64	0.60	0.96	0.26	0.42	0.76	0.77	0.57	0.38	0.73	-0.05	0.71	0.05	0.72	0.61	0.81	-0.06	1.20	0.09	1.05	-0.20	-0.30	-0.13	0.34	-0.43	-0.09	0.64	1.55	1.29	0.89	0.43	0.79	-0.18	NA	0.86	NA	0.43	0.00	0.29	2.47	0.78	1.09	1.15	1.19	0.99	0.55	0.48	0.75	0.99	0.84	0.38	0.31	0.29	0.70	-0.01	1.17	1.00	1.04	0.35	1.83
Phase 2: Axitinib + FOLFOX	1.62	0.63	0.68	0.88	0.72	0.70	0.28	0.28	-0.15	0.28	0.15	0.32	-0.09	0.03	0.28	-0.30	-0.20	0.02	-0.18	-0.06	-0.25	0.57	0.30	0.91	0.25	-0.05	-0.21	0.12	3.00	1.05	-0.50	0.11	NA	0.04	NA	0.29	NA	0.13	NA	0.18	0.18	1.29	2.50	0.46	0.60	0.92	0.65	0.32	0.43	0.01	-0.14	-0.18	0.42	0.03	-0.50	-0.10	-0.52	-0.02	-0.90	0.06	0.04	0.27	-0.04
Phase 2: Bevacizumab + FOLFOX	2.20	0.04	-0.22	-0.40	-0.34	0.09	-0.16	-0.13	-0.03	0.06	-0.05	0.47	0.10	0.38	0.42	0.11	0.21	0.31	0.34	0.15	0.27	0.81	0.64	0.37	-0.03	0.46	0.07	0.74	-0.14	0.45	-0.64	0.80	NA	0.75	NA	1.24	0.86	1.68	0.86	1.29	1.25	-0.00	2.79	-0.08	-0.57	-0.54	-0.59	-0.18	-0.59	-0.10	-0.39	0.15	-0.51	0.17	-0.31	0.15	0.27	-0.48	-0.29	0.04	0.54	-0.08	-0.97

CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. CL for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. (NCT00460603)
Timeframe: Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1

Clearance (CL) For Bevacizumab: Phase 1

Intervention	L/hr (Geometric Mean)
	Cycle 1 Day 1	Cycle 2 Day 1
Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)	147.43	137.34
Phase 1: Axitinib + FOLFIRI (Cohort 4)	128.28	144.62
Phase 1: Axitinib + FOLFOX (Cohort 5)	99.36	53.92

CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. CL for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. (NCT00460603)
Timeframe: Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1

Clearance (CL) For Irinotecan: Phase 1

Intervention	L/hr (Geometric Mean)
	Cycle 1 Day 1	Cycle 2 Day 1
Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)	0.01	0.02

CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. (NCT00460603)
Timeframe: Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1

Clearance (CL) For Oxaliplatin: Phase 1

Intervention	L/hr (Geometric Mean)
	Cycle 1 Day 8	Cycle 2 Day 1
Phase 1: Axitinib + FOLFIRI (Cohort 4)	26.09	27.34

CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. CL for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. (NCT00460603)
Timeframe: Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1

Maximum Observed Plasma Concentration (Cmax) For 5-Fluorouracil: Phase 1

Intervention	L/hr (Geometric Mean)
	Cycle 1 Day 1	Cycle 2 Day 1
Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)	27.51	24.29
Phase 1: Axitinib + FOLFOX (Cohort 5)	30.74	24.56

PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. Cmax for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose. (NCT00460603)
Timeframe: Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1

Maximum Observed Plasma Concentration (Cmax) For Axitinib: Phase 1

Intervention	ng/mL (Geometric Mean)
	Cycle 1 Day 1	Cycle 2 Day 1
Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)	16160.85	16249.77
Phase 1: Axitinib + FOLFIRI (Cohort 4)	34436.94	39730.46
Phase 1: Axitinib + FOLFOX (Cohort 5)	19622.74	34180.87

PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3.Cmax for axitinib (AG-013736) in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose. (NCT00460603)
Timeframe: Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1

Maximum Observed Plasma Concentration (Cmax) For Bevacizumab: Phase 1

Intervention	ng/mL (Geometric Mean)
	Cycle 1 Day 8	Cycle 2 Day 1
Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)	35.57	27.51
Phase 1: Axitinib + FOLFIRI (Cohort 4)	27.14	42.48
Phase 1: Axitinib + FOLFOX (Cohort 5)	24.23	32.62

PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. Cmax for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose. (NCT00460603)
Timeframe: Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1

Maximum Observed Plasma Concentration (Cmax) For Irinotecan: Phase 1

Intervention	ng/mL (Geometric Mean)
	Cycle 1 Day 1	Cycle 2 Day 1
Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)	26460.05	26850.12

Cmax for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose. (NCT00460603)
Timeframe: Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1

Maximum Observed Plasma Concentration (Cmax) For Oxaliplatin: Phase 1

Intervention	ng/mL (Geometric Mean)
	Cycle 1 Day 1	Cycle 2 Day 1
Phase 1: Axitinib + FOLFIRI (Cohort 4)	1910.25	1788.69

PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. Cmax for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose. (NCT00460603)
Timeframe: Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1

Plasma Decay Half-Life (t1/2) For 5-Fluorouracil: Phase 1

Intervention	ng/mL (Geometric Mean)
	Cycle 1 Day 1	Cycle 2 Day 1
Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)	278.81	318.99
Phase 1: Axitinib + FOLFOX (Cohort 5)	265.05	374.03

Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. t1/2 for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. (NCT00460603)
Timeframe: Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1

Plasma Decay Half-Life (t1/2) For Axitinib: Phase 1

Intervention	hours (Mean)
	Cycle 1 Day 1	Cycle 2 Day 1
Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)	0.26	0.25
Phase 1: Axitinib + FOLFIRI (Cohort 4)	0.19	0.14
Phase 1: Axitinib + FOLFOX (Cohort 5)	0.39	0.24

Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. t1/2 for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. (NCT00460603)
Timeframe: Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1

Plasma Decay Half-Life (t1/2) For Bevacizumab: Phase 1

Intervention	hours (Mean)
	Cycle 1 Day 8	Cycle 2 Day 1
Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)	3.26	6.12
Phase 1: Axitinib + FOLFIRI (Cohort 4)	2.23	3.09
Phase 1: Axitinib + FOLFOX (Cohort 5)	3.47	1.73

Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. t1/2 for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. (NCT00460603)
Timeframe: Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1

Plasma Decay Half-Life (t1/2) For Irinotecan: Phase 1

Intervention	hours (Mean)
	Cycle 1 Day 1	Cycle 2 Day 1
Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)	205.97	210.22

Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. t1/2 for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. (NCT00460603)
Timeframe: Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1

Plasma Decay Half-Life (t1/2) For Oxaliplatin: Phase 1

Intervention	hours (Mean)
	Cycle 1 Day 1	Cycle 2 Day 1
Phase 1: Axitinib + FOLFIRI (Cohort 4)	6.45	6.75

Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. t1/2 for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. (NCT00460603)
Timeframe: Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1

5-FU Plasma Levels

Intervention	hours (Mean)
	Cycle 1 Day 1	Cycle 2 Day 1
Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)	20.63	23.30
Phase 1: Axitinib + FOLFOX (Cohort 5)	18.38	19.86

Pharmacokinetics of 5-FU - Cmax plasma levels (NCT01206465)
Timeframe: 22, 23, 45 & 46 hours during the 48 hour infusion

Pharmacokinetics of PDX- AUClast

Intervention	mg/m^2 (Mean)
22 Hours	1147
23 Hours	1159
45 Hours	1123
46 Hours	1113

Plasma concentrations versus time (at all time points) (NCT01206465)
Timeframe: Pre-treatment, end of infusion, at 15, 30, and 60 min, and then at 2, 4, 6, 8, 12, 22, 23, 24, 45, and 46 hours for PDX.

Recommended Dose of PDX Given With a Fixed Dose of 5-FU

Intervention	ng/ml *hr (Mean)
75 mg/m^2	12,818
94 mg/m^2	16300
118 mg/m^2	15680
148 mg/m^2	23570
185 mg/m^2	42121

Recommended dose of PDX given in combination with a fixed dose of 5-FU administered as a 48-hour infusion given every other weekMaximum tolerated dose will have been exceeded when 2 patients entered at a given dose level experience specified dose-limiting toxicities in the initial cycle (NCT01206465)
Timeframe: During the initial course (day 1 & 15 of a 4 week schedule)

Time to Disease Progression

Intervention	mg per meter square (Number)
Treatment (Enzyme Inhibitor Therapy)	148

Time to disease progression in all Participants (NCT01206465)
Timeframe: restaging imaging done after each two 4-week course until time of progression (longest time to progression = 588 days)

Number of Patients Experiencing Grade 3-4 Toxicity While Receiving the Combination of PDX and 5-FU

Intervention	days (Median)
Treatment (Enzyme Inhibitor Therapy)	112

Participants remained on study as long as they did not progress, and wished to continue on study (no limit on number of cycles) (NCT01206465)
Timeframe: "., From the time the subject signs the consent form and ending 4 weeks following the final chemotherapy, an average of 3 years"

Polymorphisms in Methylenetetrahydrofolate Reductase and Thymidylate Synthase

Intervention	participants (Number)
	gr 3-4 neutropenia	gr 3-4 thrombocytopenia	gr 3-4 anemia	gr 3-4 diarrhea	gr 3-4 mucositis	gr 3-4 dehydration	gr 3-4 fatigue
Treatment (Enzyme Inhibitor Therapy)	4	0	4	1	5	1	1

Number of Participants with Polymorphisms in Methylenetetrahydrofolate Reductase and Thymidylate Synthase (NCT01206465)
Timeframe: Prior to the first dose of protocol therapy

Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

Intervention	percentage of patients (Number)
	SLC19A1 80G>A	gamma glutamyl hydrolase (GGH) 401C>T	gamma glutamyl hydrolase (GGH) 452C>T	folyl polyglutamate synthase (FPGS) rs10760502A>G	folyl polyglutamate synthase (FPGS) rs1544105C>T	methylene tetrahydrofolate reductase (MTHFR 677C>T	methylene tetrahydrofolate reductase MTHFR 1298A>C	thymidylate synthase 28-bp tandem repeats (2 or 3)
Heterozygous	40.7	37.0	11.1	4.0	55.6	25.9	33.3	48.2
Homozygous Variant	7.4	7.4	0	0	18.5	18.5	14.8	37.0
Wild Type	51.9	55.6	88.9	96.0	25.9	55.6	51.9	14.8

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT02311361)
Timeframe: Date treatment consent signed to date off study, approximately 18 months and 4 days for Cohort 1/Dose Level A1, 23 months and 29 days for Cohort 2/Dose Level A2, 32 months and 19 days for Cohort C/Dose Level C1, and 44 months and 18 days for Cohort C/Dose

Overall Survival

Intervention	Participants (Count of Participants)
Durvalumab + 8 Gray (Gy) in 1 Fraction	14
Durvalumab +5 Gy in 5 Fractions	10
Durvalumab +Tremelimumab + 8 Gy in 1 Fraction	19
Durvalumab +Tremelimumab +5 Gy in 5 Fractions	20

Amount of time participants survived after therapy. (NCT02311361)
Timeframe: From study entry to death or date of last contact, whichever occurs first, up to 2 years of follow-up

Percentage of Participants With 6-month Overall Survival

Intervention	Months (Median)
Cohort A Dose Level A1	3.3
Cohort A Dose Level A2	9.0
Cohort C Dose Level C1	2.1
Cohort C Dose Level C2	4.2

Participants who survived at least 6 months after therapy. (NCT02311361)
Timeframe: 6 month

Progression Free Survival (PFS)

Intervention	percentage of participants (Number)
Cohort A Dose Level A1	26
Cohort A Dose Level A2	58
Cohort C Dose Level C1	12
Cohort C Dose Level C2	40

PFS is the defined as the median amount of time subject survives without disease progression after treatment. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). NOTE: While RECIST Progressive Disease (PD) will be noted and recorded the immune-related (IR) RECIST criteria will be applied to determine discontinuation of study treatment. For modified Immune-Related Response Criteria (irRC), only target and measurable lesions are taken into account. (NCT02311361)
Timeframe: From study entry to disease progression, death or date of last contact, whichever occurs first, an average of 6 months

Number of Adverse Events in Each Cohort With Grade 1 Through 5 Related to Study Drug

Intervention	Months (Median)
Cohort A Dose Level A1	1.7
Cohort A Dose Level A2	2.5
Cohort C Dose Level C1	0.9
Cohort C Dose Level C2	2.3

Adverse Events (AEs) are reported by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1=Mild, Grade 2= Moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Fatal. (NCT02311361)
Timeframe: Participants were assessed from the start of study treatment at Cycle 1 then after every cycle (1 cycle = 28 days) of protocol treatment until 30 days after they were taken off treatment, approximately 4.0 months.

Tumor Response Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Measured by Computed Tomography (CT) and Magnetic Resonance Imaging (MRI)

Intervention	Adverse events (Number)
	Grade 1 Abdominal pain	Grade 1 Alanine aminotransferase increased	Grade 1 Alkaline Phosphatase increased	Grade 1 Anemia	Grade 1 Anorexia	Grade 1 Atrial fibrillation	Grade 1 Aspartate aminotransferase increased	Grade 1 Back pain	Grade 1 Blood bilirubin increased	Grade 1 Cough	Grade 1 Creatinine increased	Grade 1 Diarrhea	Grade 1 Dizziness	Grade 1 Dry mouth	Grade 1 Dysgeusia	Grade 1 Endocrine disorders,Other, Elevated T3, T4	Grade 1 Eye disorders - decr. in near vision,bilat	Grade 1 - Fatigue	Grade 1 Fever	Grade 1 Headache	Grade 1 Hemorrhoidal hemorrhage	Grade 1 Hoarseness	Grade 1 Hyperglycemia	Grade 1 - Hyperkalemia	Grade 1 Hyperuricemia	Grade 1 Hypoalbuminemia	Grade 1 Hypocalcemia	Grade 1 - Hyponatremia	Grade 1 Hypothyroidism	Grade 1 Infusion related reaction	Grade 1 Lymphocyte count decreased	Grade 1 Mucositis	Grade 1 Musculoskeletal & connective tissue	Grade 1 Nausea	Grade 1 Neutrophil count decreased	Grade 1 Pain	Grade 1 Platelet count decreased	Grade 1 Pruritis	Grade 1 Rash maculo-papular	Grade 1 Serum amylase increased	Grade 1 - Skin/subc tissue disorder - Night sweats	Grade 1 Skin/subc tissue disorder - Rash	Grade 1 Skin/subc tissue - Psoriasis	Grade 1 Skin/subc tissue disorder - Itching	Grade 1 Skin/subc tissue disorder-Skinpeeling hand	Grade 1 Vertigo	Grade 1 Vomiting	Grade 1 Weight loss	Grade 1 White blood cell decreased	Grade 2 Abdominal pain	Grade 2 Anemia	Grade 2 Anorexia	Grade 2 Autoimmune disorder	Grade 2 Diarrhea	Grade 2 Dysgeusia	Grade 2 Endocrine disorders - TSH elev-Hypothyroid	Grade 2 Fatigue	Grade 2 Fecal incontinence	Grade 2 Fever	Grade 2 Gastroesophageal reflux disease	Grade 2 Hyperglycemia	Grade 2 Hypoalbuminemia	Grade 2 Hypothyroidism
Cohort A Dose Level A1	0	1	0	3	1	0	1	0	0	0	0	0	0	1	0	0	0	1	1	0	1	0	0	0	0	0	0	2	0	0	15	0	0	0	0	0	2	1	0	0	0	0	0	0	0	0	0	0	1	0	3	0	0	0	0	0	0	0	0	0	0	0	0
Cohort A Dose Level A2	0	0	2	3	0	0	0	0	0	0	0	1	0	0	0	0	1	2	1	2	0	0	0	0	0	0	0	0	0	0	20	0	3	1	0	0	0	1	1	0	0	0	1	1	0	1	0	0	4	0	1	0	0	1	0	0	0	1	0	1	0	0	0
Cohort C Dose Level C1	0	0	0	9	0	0	1	0	1	0	0	1	0	0	1	1	0	0	1	0	0	1	2	0	0	0	0	3	0	0	17	0	0	3	0	0	7	2	1	0	1	1	0	1	1	0	1	0	1	0	9	0	0	2	0	1	2	0	0	0	1	0	1
Cohort C Dose Level C2	1	5	2	9	3	1	6	1	1	1	1	7	1	0	0	0	0	7	1	0	0	0	0	1	1	5	1	4	1	2	26	1	0	2	1	1	13	3	2	3	1	0	0	0	0	0	4	1	7	1	10	2	1	4	1	0	5	0	1	0	0	1	0

Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD. (NCT02311361)
Timeframe: At screening then every 8 weeks until disease progression or patient is taken off the trial, whichever comes first, approximately 6 months.

Reviews

Trials

Other Studies

355 other studies available for fluorouracil and Cancer of Gastrointestinal Tract

Article	Year
Genotype-based chemotherapy for patients with gastrointestinal tumors: focus on oxaliplatin, irinotecan, and fluoropyrimidines. Drug metabolism and personalized therapy, 2022, 09-01, Volume: 37, Issue:3 Topics: Fluorouracil; Gastrointestinal Neoplasms; Genotype; Humans; Irinotecan; Oxaliplatin	2022
Gastrointestinal malignancy in cystic fibrosis. Paediatric respiratory reviews, 2020, Volume: 35 Topics: Adenocarcinoma, Clear Cell; Adult; Antineoplastic Combined Chemotherapy Protocols; Bone Neoplasms; C	2020
Comparison of Platinum/S-1 and Platinum/5-Fluorouracil as First-Line Chemotherapy for Advanced Gastric or Gastroesophageal Junction Cancer: A Meta-Analysis Based on Randomized Controlled Trials. Chemotherapy, 2020, Volume: 65, Issue:1-2 Topics: Antineoplastic Agents; Coordination Complexes; Disease-Free Survival; Drug Combinations; Drug Therap	2020
The Role of Fluoropirimidines in Gastrointestinal Tumours: from the Bench to the Bed. Journal of gastrointestinal cancer, 2017, Volume: 48, Issue:2 Topics: Administration, Oral; Antimetabolites, Antineoplastic; Antineoplastic Combined Chemotherapy Protocol	2017
Trifluridine/tipiracil: an emerging strategy for the management of gastrointestinal cancers. Future oncology (London, England), 2018, Volume: 14, Issue:16 Topics: Antineoplastic Combined Chemotherapy Protocols; Bevacizumab; Camptothecin; Clinical Trials as Topic;	2018
Relevance of BMJ open, 2018, 05-26, Volume: 8, Issue:5 Topics: Alleles; Antimetabolites, Antineoplastic; Female; Fluorouracil; Gastrointestinal Neoplasms; Humans;	2018
Immunological off-target effects of standard treatments in gastrointestinal cancers. Annals of oncology : official journal of the European Society for Medical Oncology, 2014, Volume: 25, Issue:1 Topics: Animals; Antineoplastic Agents; Camptothecin; Cytotoxicity, Immunologic; Deoxycytidine; Fluorouracil	2014
Comparison of the efficacy and safety of S-1-based and capecitabine-based regimens in gastrointestinal cancer: a meta-analysis. PloS one, 2014, Volume: 9, Issue:1 Topics: Antineoplastic Combined Chemotherapy Protocols; Capecitabine; Deoxycytidine; Drug Combinations; Fluo	2014
MicroRNAs in gastrointestinal cancer: prognostic significance and potential role in chemoresistance. Expert opinion on biological therapy, 2014, Volume: 14, Issue:8 Topics: Antineoplastic Combined Chemotherapy Protocols; Biomarkers, Tumor; Cisplatin; Drug Resistance, Neopl	2014
Survival benefit from S-1 as compared to Fluorouracil in Asian patients with advanced gastrointestinal cancer: a meta-analysis. Cancer science, 2014, Volume: 105, Issue:8 Topics: Antineoplastic Agents; Asian People; Drug Combinations; Fluorouracil; Gastrointestinal Neoplasms; Hu	2014
5-Fluorouracil derivatives: a patent review (2012 - 2014). Expert opinion on therapeutic patents, 2015, Volume: 25, Issue:10 Topics: Animals; Antimetabolites, Antineoplastic; Cytokines; Drug Design; Drug Resistance, Neoplasm; Fluorou	2015
Rational selection of predictive pharmacogenomics test for the Fluoropyrimidine/Oxaliplatin based therapy. European review for medical and pharmacological sciences, 2015, Volume: 19, Issue:22 Topics: Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Colorectal Neoplasms; Fluorou	2015
Chemotherapy for advanced non-pancreatic well-differentiated neuroendocrine tumours of the gastrointestinal tract, a systematic review and meta-analysis: A lost cause? Cancer treatment reviews, 2016, Volume: 44 Topics: Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Capecitabine; Dacarbazine; Di	2016
Autophagy in 5-Fluorouracil Therapy in Gastrointestinal Cancer: Trends and Challenges. Chinese medical journal, 2016, Feb-20, Volume: 129, Issue:4 Topics: Antimetabolites, Antineoplastic; Autophagy; Drug Resistance, Neoplasm; Fluorouracil; Gastrointestina	2016
The one-carbon metabolism pathway highlights therapeutic targets for gastrointestinal cancer (Review). International journal of oncology, 2017, Volume: 50, Issue:4 Topics: Aminohydrolases; Antineoplastic Agents; Fluorouracil; Folic Acid; Folic Acid Antagonists; Gastrointe	2017
Is levoleucovorin an alternative to racemic leucovorin? A literature review. Clinical colorectal cancer, 2009, Volume: 8, Issue:4 Topics: Antimetabolites, Antineoplastic; Fluorouracil; Gastrointestinal Neoplasms; Humans; Leucovorin; Stere	2009
Synergistic role of curcumin with current therapeutics in colorectal cancer: minireview. Nutrition and cancer, 2009, Volume: 61, Issue:6 Topics: Adenoma; Animals; Anticarcinogenic Agents; Antineoplastic Agents, Phytogenic; Antineoplastic Combine	2009
S-1 for the treatment of gastrointestinal cancer. Expert opinion on pharmacotherapy, 2012, Volume: 13, Issue:13 Topics: Animals; Antimetabolites, Antineoplastic; Antineoplastic Combined Chemotherapy Protocols; Camptothec	2012
Capecitabine and radiation therapy for advanced gastrointestinal malignancies. Oncology (Williston Park, N.Y.), 2002, Volume: 16, Issue:12 Suppl N Topics: Antineoplastic Agents; Capecitabine; Celecoxib; Clinical Trials as Topic; Combined Modality Therapy;	2002
EXPERIMENTAL AND CLINICAL USE OF FLUORINATED PYRIMIDINES IN CANCER CHEMOTHERAPY. Cancer research, 1963, Volume: 23 Topics: Breast Neoplasms; Carbon Isotopes; Floxuridine; Fluorouracil; Gastrointestinal Neoplasms; Humans; Me	1963
[Oral 5-FU and digestive cancers]. Gastroenterologie clinique et biologique, 2004, Volume: 28, Issue:3 Topics: Antimetabolites, Antineoplastic; Antineoplastic Combined Chemotherapy Protocols; Colorectal Neoplasm	2004
Thymidylate synthase expression and prognosis of patients with gastrointestinal cancers receiving adjuvant chemotherapy: a review. Langenbeck's archives of surgery, 2004, Volume: 389, Issue:5 Topics: Antimetabolites, Antineoplastic; Chemotherapy, Adjuvant; Clinical Trials as Topic; Combined Modality	2004
Development of and clinical experience with capecitabine (Xeloda) in the treatment of solid tumours. European journal of oncology nursing : the official journal of European Oncology Nursing Society, 2004, Volume: 8 Suppl 1 Topics: Administration, Oral; Animals; Antimetabolites, Antineoplastic; Breast Neoplasms; Capecitabine; Clin	2004
Apoptotic and anti-angiogenic strategies in liver and gastrointestinal malignancies. Journal of surgical oncology, 2005, Jun-15, Volume: 90, Issue:4 Topics: Angiogenesis Inhibitors; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic C	2005
Strategies for management of the peritoneal surface component of cancer: cytoreductive surgery plus perioperative intraperitoneal chemotherapy. Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners, 2005, Volume: 11, Issue:3 Topics: Antineoplastic Agents; Chemotherapy, Adjuvant; Combined Modality Therapy; Doxorubicin; Female; Fluor	2005
[Progress in the treatment of gastrointestinal cancers due to introduction of neoadjuvant concept]. Magyar sebeszet, 2006, Volume: 59, Issue:5 Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Chemotherapy, Adjuvant; Ci	2006
[Angiogenesis targeting in gastro-intestinal cancers]. Bulletin du cancer, 2007, Volume: 94, Issue:7 Suppl Topics: Angiogenesis Inhibitors; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic C	2007
[The diffuse endocrine system and the carcinoids of the alimentary tract. Part I: Orthological aspects and common morphological features of the carcinoids (author's transl)]. Zeitschrift fur Gastroenterologie, 1982, Volume: 20, Issue:4 Topics: Adrenocorticotropic Hormone; Aged; Appendiceal Neoplasms; APUD Cells; Carcinoid Tumor; Carmustine; C	1982
[Hepatic tumors]. Acta medica Austriaca, 1983, Volume: 10, Issue:4 Topics: alpha-Fetoproteins; Angiography; Breast Neoplasms; Bronchial Neoplasms; Carcinoembryonic Antigen; Ca	1983
Systemic chemotherapy for advanced gastrointestinal cancer. Southern medical journal, 1980, Volume: 73, Issue:8 Topics: Antineoplastic Agents; Apudoma; Biliary Tract Neoplasms; Colonic Neoplasms; Drug Therapy, Combinatio	1980
Possibilities and limitations of the cytostatic treatment of gastrointestinal carcinoma. Hepato-gastroenterology, 1982, Volume: 29, Issue:3 Topics: Adenocarcinoma; Antineoplastic Agents; Colonic Neoplasms; Doxorubicin; Drug Therapy, Combination; Es	1982
Adjuvant therapy for gastrointestinal cancer. Current opinion in oncology, 1994, Volume: 6, Issue:4 Topics: Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Chemotherapy, Adjuvant; Clini	1994
Adjuvant postoperative therapy of gastrointestinal malignancies. Oncology (Williston Park, N.Y.), 1994, Volume: 8, Issue:7 Topics: Antineoplastic Combined Chemotherapy Protocols; Chemotherapy, Adjuvant; Colonic Neoplasms; Combined	1994
Cytokine-based biotherapy of gastrointestinal tumors. The Clinical investigator, 1994, Volume: 72, Issue:7 Topics: Clinical Trials as Topic; Colorectal Neoplasms; Cytokines; Drug Synergism; Fluorouracil; Gastrointes	1994
Chronotherapy for gastrointestinal cancers. Current opinion in oncology, 1996, Volume: 8, Issue:4 Topics: Antineoplastic Agents; Chronotherapy; Clinical Trials as Topic; Colorectal Neoplasms; Drug Delivery	1996
Infusional 5-fluorouracil in the treatment of gastrointestinal cancers: the Royal Marsden Hospital experience. Annals of oncology : official journal of the European Society for Medical Oncology, 1997, Volume: 8, Issue:2 Topics: Antimetabolites, Antineoplastic; Colorectal Neoplasms; Esophageal Neoplasms; Fluorouracil; Gastroint	1997
Infusional 5-fluorouracil in the treatment of gastrointestinal cancers: The Royal Marsden Hospital experience. The Journal of infusional chemotherapy, 1996,Summer, Volume: 6, Issue:3 Topics: Ambulatory Care; Antimetabolites, Antineoplastic; Biliary Tract Neoplasms; Clinical Trials as Topic;	1996
[New anti-cancer drugs for gastrointestinal cancers]. Gan to kagaku ryoho. Cancer & chemotherapy, 1997, Volume: 24, Issue:13 Topics: Amino Acids; Antidotes; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Camptothecin; Clin	1997
[Paths of innovative surgery in gastrointestinal cancer in our department]. Nihon Geka Gakkai zasshi, 1997, Volume: 98, Issue:9 Topics: Antibodies, Monoclonal; Combined Modality Therapy; Drug Delivery Systems; Fluorouracil; Gastrointest	1997
[Gastrointestinal cancer and oral anticancer agents]. Gan to kagaku ryoho. Cancer & chemotherapy, 1999, Volume: 26, Issue:3 Topics: Administration, Oral; Antimetabolites, Antineoplastic; Antineoplastic Agents; Camptothecin; Drug Com	1999
[Combination therapy of continuous venous infusion (CVI) of 5-FU and low dose consecutive cisplatin (CDDP), and the new oral anti-cancer drug S-1 for advanced gastro-intestinal cancer]. Gan to kagaku ryoho. Cancer & chemotherapy, 1999, Volume: 26, Issue:4 Topics: Administration, Oral; Animals; Antineoplastic Combined Chemotherapy Protocols; Bone Marrow; Cell Cyc	1999
The role of UFT in combined-modality therapy. Oncology (Williston Park, N.Y.), 1999, Volume: 13, Issue:10 Suppl 5 Topics: Administration, Oral; Animals; Antineoplastic Combined Chemotherapy Protocols; Clinical Trials as To	1999
[Problems and prospects for combined chemotherapy with 5-fluorouracil and low-dose cisplatin]. Gan to kagaku ryoho. Cancer & chemotherapy, 1999, Volume: 26, Issue:11 Topics: Animals; Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Colonic Neoplasms; Female; Fluor	1999
Clinical advances with topoisomerase I inhibitors in gastrointestinal malignancies. Anti-cancer drugs, 1999, Volume: 10 Suppl 1 Topics: Antineoplastic Combined Chemotherapy Protocols; Camptothecin; Docetaxel; Enzyme Inhibitors; Fluorour	1999
[New drugs in gastrointestinal oncology. Current status and future directions]. Gastroenterologie clinique et biologique, 1999, Volume: 23, Issue:11 Topics: Antineoplastic Agents; Camptothecin; Capecitabine; Deoxycytidine; Docetaxel; Floxuridine; Fluorourac	1999
Chemotherapy in the treatment of neuroendocrine malignant tumors. Digestion, 2000, Volume: 62 Suppl 1 Topics: Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Dacarbazine; Doxorubicin; Etoposide; Fluo	2000
Chronotherapy with 5-fluorouracil and other drugs in gastrointestinal malignancies. Chronotherapy Group of the European Organization for Research and Treatment of Cancer. Seminars in oncology, 2000, Volume: 27, Issue:5 Suppl 10 Topics: Animals; Antineoplastic Agents; Chronobiology Phenomena; Chronotherapy; Clinical Trials as Topic; Co	2000
[Outpatient treatment for gastrointestinal tract cancer in the Department of Surgery]. Gan to kagaku ryoho. Cancer & chemotherapy, 2000, Volume: 27, Issue:11 Topics: Ambulatory Care; Antineoplastic Combined Chemotherapy Protocols; Camptothecin; Chemotherapy, Adjuvan	2000
Safety of oxaliplatin in the treatment of colorectal cancer. Oncology (Williston Park, N.Y.), 2000, Volume: 14, Issue:12 Suppl 1 Topics: Antineoplastic Combined Chemotherapy Protocols; Clinical Trials, Phase II as Topic; Clinical Trials,	2000
Progress report. Cytotoxic therapy for gastrointestinal carcinoma. Gut, 1976, Volume: 17, Issue:4 Topics: Adenocarcinoma; Antibiotics, Antineoplastic; Antimetabolites, Antineoplastic; Bleomycin; Carcinoma,	1976
[Chemotherapy of gastrointestinal tumors (review of the literature)]. Onkologie, 1978, Volume: 1, Issue:6 Topics: Ancitabine; Carcinoma, Hepatocellular; Colonic Neoplasms; Doxorubicin; Drug Therapy, Combination; Fl	1978
Management of gastrointestinal cancer. The Medical clinics of North America, 1977, Volume: 61, Issue:5 Topics: Antineoplastic Agents; Clinical Trials as Topic; Colonic Neoplasms; Drug Therapy, Combination; Fluor	1977
Chemotherapy of gastrointestinal cancer. The New England journal of medicine, 1978, Nov-09, Volume: 299, Issue:19 Topics: Apudoma; Colonic Neoplasms; Drug Therapy, Combination; Fluorouracil; Gastrointestinal Neoplasms; Hum	1978
[Evaluation of treatment with 5FU in tumors of the gastrointestinal tract]. Harefuah, 1976, Volume: 91, Issue:5-6 Topics: Evaluation Studies as Topic; Fluorouracil; Gastrointestinal Neoplasms; Humans	1976
Treatment of gastrointestinal and renal adenocarcinomas with interferon-alpha. Biotherapy (Dordrecht, Netherlands), 1992, Volume: 4, Issue:3 Topics: Adenocarcinoma; Antineoplastic Combined Chemotherapy Protocols; Clinical Trials as Topic; Drug Inter	1992
Clinical trials with 5-fluorouracil, folinic acid and cisplatin in patients with gastrointestinal malignancies. Journal of chemotherapy (Florence, Italy), 1990, Volume: 2 Suppl 1 Topics: Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Colorectal Neoplasms; Drug Evaluation; Fl	1990
[Interdisciplinary therapy concepts in primary and secondary neoplasms of the liver]. Zeitschrift fur Gastroenterologie. Verhandlungsband, 1989, Volume: 24 Topics: Carcinoma, Hepatocellular; Combined Modality Therapy; Floxuridine; Fluorouracil; Follow-Up Studies;	1989
Intraperitoneal chemotherapy for malignant diseases of the gastrointestinal tract. Surgery, gynecology & obstetrics, 1987, Volume: 164, Issue:1 Topics: Antineoplastic Agents; Chemotherapy, Cancer, Regional Perfusion; Fluorouracil; Gastrointestinal Neop	1987
5-Fluorouracil in the treatment of gastrointestinal neoplasia. The New England journal of medicine, 1973, Jan-25, Volume: 288, Issue:4 Topics: Administration, Oral; Antineoplastic Agents; Floxuridine; Fluorouracil; Gastrointestinal Neoplasms;	1973
[Cytostatics for improvement of clinical tumor surgery]. Zentralblatt fur Chirurgie, 1973, Sep-01, Volume: 98, Issue:35 Topics: Antineoplastic Agents; Breast Neoplasms; Bronchial Neoplasms; Female; Fluorouracil; Gastrointestinal	1973

Article	Year
Ibudilast for prevention of oxaliplatin-induced acute neurotoxicity: a pilot study assessing preliminary efficacy, tolerability and pharmacokinetic interactions in patients with metastatic gastrointestinal cancer. Cancer chemotherapy and pharmacology, 2020, Volume: 86, Issue:4 Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Drug Interactions; Female; Fluorouracil; Gastr	2020
A phase 1 study of ADI-PEG 20 and modified FOLFOX6 in patients with advanced hepatocellular carcinoma and other gastrointestinal malignancies. Cancer chemotherapy and pharmacology, 2018, Volume: 82, Issue:3 Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Biomarkers, Tumor; Carcinoma, Hepatocel	2018
Intermittent dosing of axitinib combined with chemotherapy is supported by (18)FLT-PET in gastrointestinal tumours. British journal of cancer, 2014, Feb-18, Volume: 110, Issue:4 Topics: Adult; Aged; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Axit	2014
Capecitabine and streptozocin ± cisplatin in advanced gastroenteropancreatic neuroendocrine tumours. European journal of cancer (Oxford, England : 1990), 2014, Volume: 50, Issue:5 Topics: Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Combined Chemotherapy Protocols; Capecitabine	2014
Multicenter retrospective analysis of systemic chemotherapy for advanced neuroendocrine carcinoma of the digestive system. Cancer science, 2014, Volume: 105, Issue:9 Topics: Antineoplastic Combined Chemotherapy Protocols; Camptothecin; Carboplatin; Carcinoma, Neuroendocrine	2014
Bevacizumab plus capecitabine in patients with progressive advanced well-differentiated neuroendocrine tumors of the gastro-intestinal (GI-NETs) tract (BETTER trial)--a phase II non-randomised trial. European journal of cancer (Oxford, England : 1990), 2014, Volume: 50, Issue:18 Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized; Antineoplas	2014
[Magnesium isoglycyrrhizinate prevention of chemotherapy-induced liver damage during initial treatment of patients with gastrointestinal tumors]. Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology, 2015, Volume: 23, Issue:3 Topics: Alanine Transaminase; Alkaline Phosphatase; Antineoplastic Combined Chemotherapy Protocols; Aspartat	2015
Clinical curative effect of oxaliplatin combined with flurouracil in the treatment of gastrointestinal tumor. Pakistan journal of pharmaceutical sciences, 2015, Volume: 28, Issue:3 Suppl Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; China; Drug Administration Schedule; Fe	2015
Mapisal Versus Urea Cream as Prophylaxis for Capecitabine-Associated Hand-Foot Syndrome: A Randomized Phase III Trial of the AIO Quality of Life Working Group. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2015, Aug-01, Volume: 33, Issue:22 Topics: Administration, Cutaneous; Adult; Aged; Antimetabolites, Antineoplastic; Antioxidants; Breast Neopla	2015
Mapisal Versus Urea Cream as Prophylaxis for Capecitabine-Associated Hand-Foot Syndrome: A Randomized Phase III Trial of the AIO Quality of Life Working Group. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2015, Aug-01, Volume: 33, Issue:22 Topics: Administration, Cutaneous; Adult; Aged; Antimetabolites, Antineoplastic; Antioxidants; Breast Neopla	2015
Mapisal Versus Urea Cream as Prophylaxis for Capecitabine-Associated Hand-Foot Syndrome: A Randomized Phase III Trial of the AIO Quality of Life Working Group. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2015, Aug-01, Volume: 33, Issue:22 Topics: Administration, Cutaneous; Adult; Aged; Antimetabolites, Antineoplastic; Antioxidants; Breast Neopla	2015
Mapisal Versus Urea Cream as Prophylaxis for Capecitabine-Associated Hand-Foot Syndrome: A Randomized Phase III Trial of the AIO Quality of Life Working Group. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2015, Aug-01, Volume: 33, Issue:22 Topics: Administration, Cutaneous; Adult; Aged; Antimetabolites, Antineoplastic; Antioxidants; Breast Neopla	2015
A phase 1 clinical trial of sequential pralatrexate followed by a 48-hour infusion of 5-fluorouracil given every other week in adult patients with solid tumors. Cancer, 2015, Nov-01, Volume: 121, Issue:21 Topics: Adult; Aged; Aged, 80 and over; Aminopterin; Antineoplastic Agents; Carcinoma, Non-Small-Cell Lung;	2015
Phase I trial of combination of FOLFIRI and pasireotide, a somatostatin analogue, in advanced gastrointestinal malignancies. Investigational new drugs, 2015, Volume: 33, Issue:5 Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Camptothecin; Dose-Response Relationshi	2015
Phase I trial of FOLFIRI in combination with sorafenib and bevacizumab in patients with advanced gastrointestinal malignancies. Investigational new drugs, 2016, Volume: 34, Issue:1 Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Bevacizumab; Camptot	2016
A phase III study evaluating oral glutamine and transforming growth factor-beta 2 on chemotherapy-induced toxicity in patients with digestive neoplasm. Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver, 2016, Volume: 48, Issue:3 Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Cachexia; Dietary Supplements; Double-Blind Me	2016
Efficacy of Sucralfate Mouth Wash in Prevention of 5-fluorouracil Induced Oral Mucositis: A Prospective, Randomized, Double-Blind, Controlled Trial. Nutrition and cancer, 2016, Volume: 68, Issue:3 Topics: Adult; Aged; Antimetabolites, Antineoplastic; Antineoplastic Combined Chemotherapy Protocols; Female	2016
Efficacy of Sucralfate Mouth Wash in Prevention of 5-fluorouracil Induced Oral Mucositis: A Prospective, Randomized, Double-Blind, Controlled Trial. Nutrition and cancer, 2016, Volume: 68, Issue:3 Topics: Adult; Aged; Antimetabolites, Antineoplastic; Antineoplastic Combined Chemotherapy Protocols; Female	2016
Efficacy of Sucralfate Mouth Wash in Prevention of 5-fluorouracil Induced Oral Mucositis: A Prospective, Randomized, Double-Blind, Controlled Trial. Nutrition and cancer, 2016, Volume: 68, Issue:3 Topics: Adult; Aged; Antimetabolites, Antineoplastic; Antineoplastic Combined Chemotherapy Protocols; Female	2016
Efficacy of Sucralfate Mouth Wash in Prevention of 5-fluorouracil Induced Oral Mucositis: A Prospective, Randomized, Double-Blind, Controlled Trial. Nutrition and cancer, 2016, Volume: 68, Issue:3 Topics: Adult; Aged; Antimetabolites, Antineoplastic; Antineoplastic Combined Chemotherapy Protocols; Female	2016
Phase I dose escalation study with irinotecan, capecitabine, epirubicin, and granulocyte colony-stimulating factor support for patients with solid malignancies. American journal of clinical oncology, 2008, Volume: 31, Issue:3 Topics: Adenocarcinoma; Administration, Oral; Adult; Aged; Alopecia; Antineoplastic Combined Chemotherapy Pr	2008
Phase I study of biweekly oxaliplatin, gemcitabine and capecitabine in patients with advanced upper gastrointestinal malignancies. Annals of oncology : official journal of the European Society for Medical Oncology, 2008, Volume: 19, Issue:10 Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Biliary Tract Neoplasms; Capecitabine;	2008
[Influence of chemotherapy with FOLFOX protocol on sex hormones of male patients and the protective effect of herbal medicines for reinforcing Shen and supplementing qi on it]. Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine, 2008, Volume: 28, Issue:11 Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Drug Therapy, Combination; Drugs, Chinese Herb	2008
A phase I dose escalation study of a pharmacobiologically based scheduling of capecitabine and mitomycin C in patients with gastrointestinal malignancies. Cancer chemotherapy and pharmacology, 2010, Volume: 65, Issue:5 Topics: Adult; Aged; Antibiotics, Antineoplastic; Antimetabolites, Antineoplastic; Antineoplastic Combined C	2010
Two phase I studies of concurrent radiation therapy with continuous-infusion 5-fluorouracil plus epirubicin, and either cisplatin or irinotecan for locally advanced upper gastrointestinal adenocarcinomas. Cancer chemotherapy and pharmacology, 2011, Volume: 67, Issue:3 Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Camptothecin; Cisplatin	2011
A new pharmacological approach to gastrointestinal cancer at high risk of relapse based on maintenance of the cytostatic effect. Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine, 2010, Volume: 31, Issue:5 Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Chemotherapy, Adjuvant; Combined Modality Ther	2010
An explorative study on the clinical utility of baseline and serial serum tumour marker measurements in advanced upper gastrointestinal cancer. Oncology reports, 2010, Volume: 24, Issue:6 Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Biomarkers, Pharmacolog	2010
Fish oil supplementation improves neutrophil function during cancer chemotherapy. Lipids, 2012, Volume: 47, Issue:4 Topics: Antineoplastic Agents; Brazil; Dietary Supplements; Docosahexaenoic Acids; Eicosapentaenoic Acid; Fe	2012
Effects of sequential chemotherapy of FOLFIRI/FOLFOX on the endocrine axes of ACTH-cortisol and renin-angiotensin-aldosterone. Journal of neuro-oncology, 2012, Volume: 108, Issue:3 Topics: Adrenocorticotropic Hormone; Aged; Aldosterone; Angiotensins; Antineoplastic Combined Chemotherapy P	2012
Antiemetic control with palonosetron in patients with gastrointestinal cancer receiving a fluoropyrimidine-based regimen in addition to either irinotecan or oxaliplatin: a retrospective study. Oncology, 2012, Volume: 83, Issue:3 Topics: Antiemetics; Antineoplastic Combined Chemotherapy Protocols; Camptothecin; Capecitabine; Deoxycytidi	2012
[Randomized controlled clinical trial of kang'ai injection in gastrointestinal cancerchemotherapy patients]. Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica, 2012, Volume: 37, Issue:19 Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Case-Control Studies; Drugs, Chinese Herbal; F	2012
Ganglioside-monosialic acid (GM1) prevents oxaliplatin-induced peripheral neurotoxicity in patients with gastrointestinal tumors. World journal of surgical oncology, 2013, Jan-25, Volume: 11 Topics: Adult; Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Capecitabine; Co	2013
Chronomodulated chemotherapy in metastatic gastrointestinal cancer combining 5-FU and sodium folinate with oxaliplatin, irinotecan or gemcitabine: the Jena experience in 79 patients. Journal of cancer research and clinical oncology, 2002, Volume: 128, Issue:9 Topics: Antineoplastic Combined Chemotherapy Protocols; Biliary Tract Neoplasms; Camptothecin; Colorectal Ne	2002
Phase I clinical trial of irinotecan with oral capecitabine in patients with gastrointestinal and other solid malignancies. American journal of clinical oncology, 2002, Volume: 25, Issue:5 Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols	2002
Does leucovorin alter the intratumoral pharmacokinetics of 5-fluorouracil (5-FU)? A Southwest Oncology Group study. Investigational new drugs, 2002, Volume: 20, Issue:4 Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Protocols; Chi-Square Distribution; Drug Interactions	2002
Oxaliplatin plus irinotecan and leucovorin-modulated 5-fluorouracil triplet regimen every other week: a dose-finding study in patients with advanced gastrointestinal malignancies. Annals of oncology : official journal of the European Society for Medical Oncology, 2002, Volume: 13, Issue:12 Topics: Adolescent; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Biopsy, Needle; Camptotheci	2002
Protracted infusional 5-fluorouracil plus high-dose folinic acid combined with bolus mitomycin C in patients with gastrointestinal cancer: a phase I/II dose escalation study. British journal of cancer, 2003, Dec-01, Volume: 89, Issue:11 Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Drug Administration Sch	2003
5-Fluorouracil induces arterial vasocontractions. Annals of oncology : official journal of the European Society for Medical Oncology, 2004, Volume: 15, Issue:4 Topics: Adult; Aged; Aged, 80 and over; Antimetabolites, Antineoplastic; Brachial Artery; Endothelins; Fluor	2004
Phase II trial of capecitabine/irinotecan and capecitabine/oxaliplatin in advanced gastrointestinal cancers. Clinical colorectal cancer, 2004, Volume: 4, Issue:1 Topics: Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Camptothecin; Cap	2004
Evaluation of cardiotoxicity of a combined bolus plus infusional 5-fluorouracil/folinic acid treatment by echocardiography, plasma troponin I level, QT interval and dispersion in patients with gastrointestinal system cancers. Japanese journal of clinical oncology, 2004, Volume: 34, Issue:5 Topics: Antineoplastic Combined Chemotherapy Protocols; Drug Administration Schedule; Echocardiography; Elec	2004
Capecitabine in combination with mitomycin C in patients with gastrointestinal cancer: results of an extended multicentre phase-I trial. British journal of cancer, 2004, Aug-31, Volume: 91, Issue:5 Topics: Adult; Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Capecitabine; De	2004
Neoadjuvant induction chemotherapy followed by chemoradiation: a phase I trial of gemcitabine, cisplatin, and 5-fluorouracil for advanced pancreatic/gastrointestinal malignancies. Surgical oncology clinics of North America, 2004, Volume: 13, Issue:4 Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Chemotherapy, Adjuvant; Cisplatin; Comb	2004
Intensified bimonthly cisplatin with bolus 5-fluorouracil, continuous 5-fluorouracil and high-dose leucovorin (LV5FU2) in Patients with advanced gastrointestinal carcinomas: a phase I dose-finding and pharmacokinetic study. American journal of clinical oncology, 2004, Volume: 27, Issue:5 Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Drug Administration Schedule	2004
Concurrent RT with 5-FU/epirubicin and cisplatin or irinotecan for locally advanced upper GI adenocarcinoma. Oncology (Williston Park, N.Y.), 2004, Volume: 18, Issue:14 Suppl 1 Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Camptothecin; Chemother	2004
A phase I clinical and pharmacokinetic study of capecitabine (Xeloda) and irinotecan combination therapy (XELIRI) in patients with metastatic gastrointestinal tumours. British journal of cancer, 2005, Mar-14, Volume: 92, Issue:5 Topics: Adult; Aged; Antineoplastic Agents, Phytogenic; Antineoplastic Combined Chemotherapy Protocols; Area	2005
S-phase modulation by irinotecan: pilot studies in advanced solid tumors. Cancer chemotherapy and pharmacology, 2005, Volume: 56, Issue:5 Topics: Adenocarcinoma; Antimetabolites, Antineoplastic; Antineoplastic Agents, Phytogenic; Antineoplastic C	2005
A phase I study of docetaxel, Cisplatin, 5-Fluorouracil and leucovorin. Oncology, 2005, Volume: 68, Issue:4-6 Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Docetaxel; Dose-Response Rel	2005
Oral Xeloda plus bi-platinu two-way combined chemotherapy in treatment of advanced gastrointestinal malignancies. World journal of gastroenterology, 2005, Jul-28, Volume: 11, Issue:28 Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antimetabolites, Antineoplastic; Antineoplasti	2005
Chronomodulated chemotherapy with oxaliplatin, 5-FU and sodium folinate in metastatic gastrointestinal cancer patients: original analysis of non-hematological toxicity and patient characteristics in a pilot investigation. International journal of clinical pharmacology and therapeutics, 2006, Volume: 44, Issue:1 Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Body Mass Index; Chronotherapy; Diarrhe	2006
Capecitabine plus weekly oxaliplatin in gastrointestinal tumors: a phase I study. American journal of clinical oncology, 2006, Volume: 29, Issue:1 Topics: Administration, Oral; Aged; Antineoplastic Combined Chemotherapy Protocols; Capecitabine; Deoxycytid	2006
Pharmacokinetics of oxaliplatin and non-hematological toxicity in metastatic gastrointestinal cancer patients treated with chronomodulated oxaliplatin, 5-FU and sodium folinate in a pilot investigation. International journal of clinical pharmacology and therapeutics, 2006, Volume: 44, Issue:3 Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Area Under Curve; Chronotherapy; Female	2006
A phase II study of irinotecan with 5-fluorouracil and leucovorin in patients with pretreated gastroenteropancreatic well-differentiated endocrine carcinomas. Oncology, 2006, Volume: 70, Issue:2 Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Camptothecin; Carcinoma; Drug Administr	2006
Fluorouracil-based chemotherapy in patients with gastrointestinal malignancies: influence of nutritional folate status on toxicity. Journal of chemotherapy (Florence, Italy), 2007, Volume: 19, Issue:6 Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Female; Fluorouracil; Folic	2007
Double-blind, placebo-controlled, randomized study of chlorhexidine prophylaxis for 5-fluorouracil-based chemotherapy-induced oral mucositis with nonblinded randomized comparison to oral cooling (cryotherapy) in gastrointestinal malignancies. Cancer, 2008, Apr-01, Volume: 112, Issue:7 Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Chemotherapy, Adjuva	2008
A trial of high-dose 5-fluorouracil with razoxane or adriamycin in the treatment of advanced adenocarcinoma of the gastrointestinal tract. American journal of clinical oncology, 1983, Volume: 6, Issue:4 Topics: Adenocarcinoma; Clinical Trials as Topic; Colonic Neoplasms; Doxorubicin; Drug Administration Schedu	1983
[Clinical evaluation of combination chemotherapy of aclacinomycin A (ACM) and 5-fluorouracil (5-FU) for advanced carcinoma of gastrointestinal tract]. Gan to kagaku ryoho. Cancer & chemotherapy, 1982, Volume: 9, Issue:4 Topics: Aclarubicin; Antibiotics, Antineoplastic; Bile Duct Neoplasms; Clinical Trials as Topic; Colonic Neo	1982
Comparison of ftorafur with 5-fluorouracil in combination chemotherapy of advanced gastrointestinal carcinoma. Recent results in cancer research. Fortschritte der Krebsforschung. Progres dans les recherches sur le cancer, 1981, Volume: 79 Topics: Adult; Carmustine; Drug Therapy, Combination; Female; Fluorouracil; Gastrointestinal Neoplasms; Huma	1981
[Clinical evaluation of chemoimmunotherapy for advanced gastrointestinal cancer using a combined regimen of 5-fluorouracil, adriamycin and levamisole]. Gan to kagaku ryoho. Cancer & chemotherapy, 1983, Volume: 10, Issue:2 Pt Topics: Doxorubicin; Drug Therapy, Combination; Fluorouracil; Gastrointestinal Neoplasms; Humans; Levamisole	1983
Combination chemotherapy in advanced gastrointestinal malignancy. Oncology, 1980, Volume: 37, Issue:1 Topics: Adenocarcinoma; Antineoplastic Agents; Bone Marrow; Clinical Trials as Topic; Drug Therapy, Combinat	1980
The efficacy of 5-fluorouracil, mitomycin C, and methyl CCNU in advanced gastrointestinal malignancy. Oncology, 1981, Volume: 38, Issue:3 Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Agents; Clinical Trials as Topic; Colonic Neoplasms; Dru	1981
1-Hexylcarbamoyl-5-fluorouracil (HCFU)--a masked 5-fluorinated pyrimidine. Cancer treatment reviews, 1981, Volume: 8, Issue:2 Topics: Adult; Aged; Animals; Antineoplastic Agents; Breast Neoplasms; Cats; Clinical Trials as Topic; Femal	1981
Modulation of 5-fluorouracil toxicity by allopurinol in man. Cancer, 1981, Sep-15, Volume: 48, Issue:6 Topics: Adenocarcinoma; Allopurinol; Clinical Trials as Topic; Dose-Response Relationship, Drug; Fluorouraci	1981
The activity of paclitaxel in gastrointestinal tumors. Seminars in oncology, 1995, Volume: 22, Issue:5 Suppl 12 Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Agents, Phytogenic; Antineoplastic Combined Chemotherapy	1995
[Intra-arterial 5-FU/intra-venous MTX therapy for metastatic liver lesions]. Gan to kagaku ryoho. Cancer & chemotherapy, 1995, Volume: 22, Issue:11 Topics: Administration, Oral; Adult; Antineoplastic Combined Chemotherapy Protocols; Drug Administration Sch	1995
[Efficacy of repeated hepatic dearterialization combined with intra-arterial infusion chemotherapy for unresectable tumors of the liver]. Gan to kagaku ryoho. Cancer & chemotherapy, 1995, Volume: 22, Issue:11 Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Combined Modality Therapy; Doxorubi	1995
A randomised study to determine whether routine intravenous magnesium supplements are necessary in patients receiving cisplatin chemotherapy with continuous infusion 5-fluorouracil. European journal of cancer (Oxford, England : 1990), 1995, Volume: 31A, Issue:2 Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Fluorouracil; Gastrointestin	1995
[Outpatient chemotherapy with continuous infusion of 5-fluorouracil (CI 5-FU) and intravenous bolus leucovorin (IVB LV) in advanced gastrointestinal cancer]. Gan to kagaku ryoho. Cancer & chemotherapy, 1994, Volume: 21 Suppl 4 Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Drug Administration Schedule; Female; Fluorour	1994
Pharmacokinetic characteristics of 5-fluorouracil and mitomycin C in intraperitoneal chemotherapy. The Journal of pharmacy and pharmacology, 1994, Volume: 46, Issue:8 Topics: Absorption; Adult; Antineoplastic Combined Chemotherapy Protocols; Chemotherapy, Adjuvant; Chromatog	1994
Delayed chemotherapy-induced nausea is augmented by high levels of endogenous noradrenaline. British journal of cancer, 1994, Volume: 70, Issue:4 Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Circadian Rhythm; Cis	1994
Double modulation of 5-fluorouracil with interferon alpha 2a and high-dose leucovorin: a phase I and II study. British journal of cancer, 1994, Volume: 70, Issue:4 Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Dose-Response Relations	1994
5-fluorouracil and folinic acid-induced mucositis: no effect of oral glutamine supplementation. British journal of cancer, 1994, Volume: 70, Issue:4 Topics: Administration, Oral; Antineoplastic Combined Chemotherapy Protocols; Cross-Over Studies; Double-Bli	1994
Combination of carmofur and interferon-alpha-2B in advanced gastrointestinal cancer--a phase II pilot study. Acta oncologica (Stockholm, Sweden), 1994, Volume: 33, Issue:6 Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Drug Administration Schedule; Drug Synergism;	1994
[Studies of guben quyu No I combined with chemotherapy in treating cancer]. Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine, 1994, Volume: 14, Issue:7 Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; CD4-CD8 Ratio; Cyclop	1994
Weekly levofolinic acid and 5-fluorouracil plus hydroxyurea in metastatic gastrointestinal adenocarcinomas. American journal of clinical oncology, 1994, Volume: 17, Issue:6 Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Drug Administration Sch	1994
[Randomized controlled study of sequential methotrexate and 5-fluorouracil therapy with or without 5'-deoxy-5-fluorouridine against advanced gastrointestinal cancer. Hirosaki Cooperative Study Group for Cancer Chemotherapy]. Gan to kagaku ryoho. Cancer & chemotherapy, 1994, Volume: 21, Issue:8 Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Drug Administration Schedule; Female; F	1994
Phase I and pharmacokinetic study of recombinant human granulocyte-macrophage colony-stimulating factor given in combination with fluorouracil plus calcium leucovorin in metastatic gastrointestinal adenocarcinoma. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 1994, Volume: 12, Issue:3 Topics: Adenocarcinoma; Adult; Aged; Agranulocytosis; Drug Administration Schedule; Female; Fluorouracil; Ga	1994
A phase I study of escalating interferon alpha-2a combined with 5-fluorouracil and leucovorin in patients with gastrointestinal malignancies. Acta oncologica (Stockholm, Sweden), 1993, Volume: 32, Issue:5 Topics: Adult; Aged; Drug Synergism; Drug Therapy, Combination; Female; Fluorouracil; Gastrointestinal Neopl	1993
Prospective phase I evaluation of radiation therapy, 5-fluorouracil, and levamisole in locally advanced gastrointestinal cancer. International journal of radiation oncology, biology, physics, 1994, Jan-15, Volume: 28, Issue:2 Topics: Antineoplastic Combined Chemotherapy Protocols; Combined Modality Therapy; Fluorouracil; Gastrointes	1994
Fluorouracil plus folinic acid in metastatic adenocarcinoma of unknown primary site suggestive of a gastrointestinal primary. Tumori, 1993, Apr-30, Volume: 79, Issue:2 Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Female; Fluorouracil; G	1993
A phase I study of continuous infusion 5-fluorouracil plus calcium leucovorin in combination with N-(phosphonacetyl)-L-aspartate in metastatic gastrointestinal adenocarcinoma. Cancer research, 1993, Oct-15, Volume: 53, Issue:20 Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols;	1993
Phase I trial of a 5-day infusion of L-leucovorin plus daily bolus 5-fluorouracil in patients with advanced gastrointestinal malignancies. Cancer chemotherapy and pharmacology, 1993, Volume: 32, Issue:3 Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Female; Fluorouracil; G	1993
Pharmacokinetic interaction of 5-fluorouracil and interferon alpha-2b with or without folinic acid. Medical oncology (Northwood, London, England), 1995, Volume: 12, Issue:1 Topics: Antimetabolites, Antineoplastic; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protoco	1995
Hydroxyurea may increase the activity of fluorouracil plus folinic acid in advanced gastrointestinal cancer: phase II study. Cancer investigation, 1996, Volume: 14, Issue:3 Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Drug Synergism; Female; Fluorouracil; G	1996
A phase II study of oral fluorouracil for gastrointestinal cancer. Anti-cancer drugs, 1996, Volume: 7, Issue:1 Topics: Adult; Aged; Antimetabolites, Antineoplastic; Combined Modality Therapy; Diarrhea; Drug Administrati	1996
Pilot study of ambulatory infusional delivery of a multidrug regimen: cisplatin, 5-fluorouracil and leucovorin (PFL) +/- etoposide. The Journal of infusional chemotherapy, 1996,Winter, Volume: 6, Issue:1 Topics: Adult; Aged; Aged, 80 and over; Ambulatory Care; Antineoplastic Combined Chemotherapy Protocols; Car	1996
[Outpatient chemotherapy with continuous infusion of 5-fluorouracil (CI 5-FU) and intravenous bolus leucovorin (IVB LV) in advanced gastrointestinal cancer: the second report]. Gan to kagaku ryoho. Cancer & chemotherapy, 1995, Volume: 22 Suppl 4 Topics: Administration, Oral; Aged; Ambulatory Care; Antineoplastic Combined Chemotherapy Protocols; Chemoth	1995
A phase I/II study of leucovorin, carboplatin and 5-fluorouracil (LCF) in patients with carcinoma of unknown primary site or advanced oesophagogastric/pancreatic adenocarcinomas. British journal of cancer, 1997, Volume: 75, Issue:1 Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Bone Marrow; Carboplati	1997
Continuous hyperthermic peritoneal perfusion for peritoneal carcinomatosis. Journal of the Formosan Medical Association = Taiwan yi zhi, 1996, Volume: 95, Issue:2 Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Chemotherapy, Cancer, Regional Perfusio	1996
Hepatic transcatheter arterial chemoembolization alternating with systemic protracted continuous infusion 5-fluorouracil for gastrointestinal malignancies metastatic to liver: a phase II trial of the Puget Sound Oncology Consortium (PSOC 1104). Clinical cancer research : an official journal of the American Association for Cancer Research, 1999, Volume: 5, Issue:1 Topics: Adenocarcinoma; Adult; Aged; Antimetabolites, Antineoplastic; Antineoplastic Combined Chemotherapy P	1999
A pilot study of interferon alpha-2a, fluorouracil, and leucovorin given with granulocyte-macrophage colony stimulating factor in advanced gastrointestinal adenocarcinoma. Clinical cancer research : an official journal of the American Association for Cancer Research, 1999, Volume: 5, Issue:9 Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Female; Fluorouracil; G	1999
Infusions of fluorouracil and leucovorin: effects of the timing and semi-intermittency of drug delivery. Oncology, 1999, Volume: 57, Issue:3 Topics: Adenocarcinoma; Adult; Aged; Antimetabolites, Antineoplastic; Antineoplastic Combined Chemotherapy P	1999
An early phase II study of oral S-1, a newly developed 5-fluorouracil derivative for advanced and recurrent gastrointestinal cancers. The S-1 Gastrointestinal Cancer Study Group. Oncology, 1999, Volume: 57, Issue:3 Topics: Adult; Aged; Antimetabolites, Antineoplastic; Drug Combinations; Fluorouracil; Gastrointestinal Neop	1999
A pharmacokinetic study of 5-FU/leucovorin and alpha-interferon in advanced cancer. Acta oncologica (Stockholm, Sweden), 2000, Volume: 39, Issue:1 Topics: Adult; Aged; Antimetabolites, Antineoplastic; Antineoplastic Combined Chemotherapy Protocols; Breast	2000
Modulation of fluorouracil tissue pharmacokinetics by eniluracil: in-vivo imaging of drug action. Lancet (London, England), 2000, Jun-17, Volume: 355, Issue:9221 Topics: Administration, Oral; Adult; Aged; Antimetabolites, Antineoplastic; Dihydrouracil Dehydrogenase (NAD	2000
Dose escalation of CPT-11 in combination with oxaliplatin using an every two weeks schedule: a phase I study in advanced gastrointestinal cancer patients. Annals of oncology : official journal of the European Society for Medical Oncology, 2000, Volume: 11, Issue:11 Topics: Adult; Aged; Alopecia; Antimetabolites, Antineoplastic; Antineoplastic Combined Chemotherapy Protoco	2000
Management of gastrointestinal cancer. The Medical clinics of North America, 1977, Volume: 61, Issue:5 Topics: Antineoplastic Agents; Clinical Trials as Topic; Colonic Neoplasms; Drug Therapy, Combination; Fluor	1977
A controlled study of 5-fluorouracil versus 5-fluorouracil and methyl-CCNU in advanced gastrointestinal adenocarcinoma. Clinical oncology, 1977, Volume: 3, Issue:3 Topics: Adenocarcinoma; Adult; Aged; Clinical Trials as Topic; Drug Therapy, Combination; Female; Fluorourac	1977
Mitomycin-C alone and in combination with infused 5-fluorouracil to the treatment of disseminated gastrointestinal carcinomas. Medical and pediatric oncology, 1978, Volume: 4, Issue:1 Topics: Adenocarcinoma; Bone Marrow; Clinical Trials as Topic; Drug Therapy, Combination; Female; Fluorourac	1978
[A prospective multi-centre study of the response of metastatic gastrointestinal tumours (author's transl)]. Deutsche medizinische Wochenschrift (1946), 1979, Aug-31, Volume: 104, Issue:35 Topics: Adenocarcinoma; Carmustine; Fluorouracil; Gastrointestinal Neoplasms; Humans; Intestinal Neoplasms;	1979
Delta-9-tetrahydrocannabinol as an antiemetic for patients receiving cancer chemotherapy. A comparison with prochlorperazine and a placebo. Annals of internal medicine, 1979, Volume: 91, Issue:6 Topics: Adult; Aged; Antiemetics; Double-Blind Method; Dronabinol; Drug Evaluation; Fluorouracil; Gastrointe	1979
Phase III comparison of the treatment of advanced gastrointestinal cancer with bolus weekly 5-FU vs. methyl-CCNU plus bolus weekly 5-FU. A Southwest Oncology Group study. Cancer, 1976, Volume: 38, Issue:1 Topics: Adolescent; Adult; Aged; Clinical Trials as Topic; Drug Therapy, Combination; Female; Fluorouracil;	1976
Nitrosoureas: useful agents for the treatment of advanced gastrointestinal cancer. Cancer treatment reports, 1976, Volume: 60, Issue:6 Topics: Clinical Trials as Topic; Colonic Neoplasms; Cyclophosphamide; Drug Evaluation; Drug Therapy, Combin	1976
Randomized comparison of melphalan and 5-fluorouracil in the treatment of advanced gastrointestinal cancer. Cancer treatment reports, 1976, Volume: 60, Issue:9 Topics: Adult; Aged; Biliary Tract Diseases; Clinical Trials as Topic; Colonic Neoplasms; Drug Evaluation; F	1976
Distribution of 5-fluorouracil to body tissues compared after intraluminal, intravenous, and intramural administration in gastrointestinal cancer. American journal of surgery, 1977, Volume: 133, Issue:3 Topics: Aged; Female; Fluorouracil; Gastrointestinal Neoplasms; Humans; Injections; Injections, Intravenous;	1977
Combined treatment with BCG and chemotherapy for metastatic gastrointestinal cancer. Diseases of the colon and rectum, 1977, Volume: 20, Issue:3 Topics: BCG Vaccine; Colonic Neoplasms; Evaluation Studies as Topic; Fluorouracil; Gastrointestinal Neoplasm	1977
Randomized prospective trial comparing 5-fluorouracil (NSC-19893) to 5-fluorouracil and methyl-CCNU (NSC-95441) in advanced gastrointestinal cancer. Cancer treatment reports, 1976, Volume: 60, Issue:6 Topics: Adenocarcinoma; Drug Evaluation; Drug Therapy, Combination; Fluorouracil; Gastrointestinal Neoplasms	1976
[Chemotherapy for advanced and recurrent cancer patients--the effect of combination chemotherapy using cisplatin, peplomycin, mitomycin C, adriamycin, and 5-fluorouracil]. Nihon Gan Chiryo Gakkai shi, 1990, Aug-20, Volume: 25, Issue:8 Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Cisplatin; Colorectal Neopla	1990
A phase I, II study of high-dose 5-fluorouracil and high-dose leucovorin with low-dose phosphonacetyl-L-aspartic acid in patients with advanced malignancies. Cancer, 1991, Sep-15, Volume: 68, Issue:6 Topics: Adult; Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Aspartic Acid; B	1991
[Oral administration of 1-hexylcarbamoyl-5-fluorouracil (HCFU) in repeated arterial bolus chemotherapy in metastatic liver cancer of humans--preliminary randomized trial]. Gan to kagaku ryoho. Cancer & chemotherapy, 1991, Volume: 18, Issue:8 Topics: Administration, Oral; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Doxorub	1991
[Early phase II study of the combined use of AO-90 methionine-free amino acid solution and anticancer agents (5-FU and MMC) in patients with advanced and recurrent gastrointestinal cancer. AO-90 Study group]. Gan to kagaku ryoho. Cancer & chemotherapy, 1990, Volume: 17, Issue:12 Topics: Adult; Aged; Amino Acids; Antineoplastic Combined Chemotherapy Protocols; Combined Modality Therapy;	1990
Biological modification of protracted infusion of 5-fluorouracil with weekly leucovorin. A dose seeking clinical trial for patients with disseminated gastrointestinal cancers. Cancer chemotherapy and pharmacology, 1990, Volume: 26, Issue:1 Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoembryonic Antigen; Clinical Trials as T	1990
Folate nephropathy occurring during cytotoxic chemotherapy with high-dose folinic acid and 5-fluorouracil. Renal failure, 1990, Volume: 12, Issue:2 Topics: Antineoplastic Combined Chemotherapy Protocols; Drug Evaluation; Female; Fluorouracil; Gastrointesti	1990
A randomized clinical trial with a weekly regimen of 5-fluorouracil with or without folinic acid in advanced gastrointestinal adenocarcinomas: a preliminary report. Journal of chemotherapy (Florence, Italy), 1989, Volume: 1, Issue:3 Topics: Adenocarcinoma; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Drug	1989
Folinic acid (CF)/5-fluorouracil (FUra) combinations in advanced gastrointestinal carcinomas. Advances in experimental medicine and biology, 1988, Volume: 244 Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Clinical Trials as Topic; Drug Evaluati	1988
[Controlled study of MQF-OK therapy with FT and with UFT on various advanced gastrointestinal cancers. Hirosaki Cooperative Study Group of Cancer Chemotherapy]. Gan to kagaku ryoho. Cancer & chemotherapy, 1988, Volume: 15, Issue:7 Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carbazilquinone; Clinical Trials as Top	1988
Hepatic arterial ligation and portal vein infusion: a clinical trial by the Gastrointestinal Tract Cancer Group of the European Organization for Research and Treatment of Cancer. Recent results in cancer research. Fortschritte der Krebsforschung. Progres dans les recherches sur le cancer, 1986, Volume: 100 Topics: Clinical Trials as Topic; Colonic Neoplasms; Fluorouracil; Gastrointestinal Neoplasms; Hepatic Arter	1986
Treatment of gastrointestinal cancer: the Southeastern Cancer Study Group experience, 1979 to 1983. Southern medical journal, 1986, Volume: 79, Issue:10 Topics: Adenocarcinoma; Antineoplastic Combined Chemotherapy Protocols; Clinical Trials as Topic; Drug Evalu	1986
[Indications and results of cytostatic therapy in gastrointestinal tumors]. Schweizerische medizinische Wochenschrift, 1973, Feb-03, Volume: 103, Issue:5 Topics: Adult; Aged; Antineoplastic Agents; Clinical Trials as Topic; Cyclophosphamide; Dactinomycin; Evalua	1973
Controlled clinical studies of orally administered antiemetic drugs. Gastroenterology, 1969, Volume: 57, Issue:3 Topics: Antiemetics; Chlorprothixene; Fluorouracil; Gastrointestinal Neoplasms; Humans; Palliative Care; Pen	1969
Combined 5-fluorouracil and supervoltage radiation therapy of locally unresectable gastrointestinal cancer. Lancet (London, England), 1969, Oct-25, Volume: 2, Issue:7626 Topics: Adenocarcinoma; Clinical Trials as Topic; Fluorouracil; Gastrointestinal Neoplasms; Humans; Intestin	1969
Clinical effects of whole-body hyperthermia in adnanced malignancy. British medical journal, 1974, Dec-21, Volume: 4, Issue:5946 Topics: Adult; Body Temperature; Breast Neoplasms; Child; Colonic Neoplasms; Cyclophosphamide; Female; Fluor	1974
Effect of concomitant drug treatment on toxic and therapeutic activity of 5-fluorouracil (5-FU; NSC-19893). Cancer chemotherapy reports, 1972, Volume: 56, Issue:2 Topics: Adenocarcinoma; Antiemetics; Clinical Trials as Topic; Drug Antagonism; Drug Synergism; Fluorouracil	1972
Combination therapy with 5-fluorouracil (5-FU; NSC-19893) and 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU; NSC-409962) for disseminated gastrointestinal carcinoma. Cancer chemotherapy reports, 1972, Volume: 56, Issue:5 Topics: Adult; Aged; Anemia, Aplastic; Blood Cell Count; Carcinoma; Clinical Trials as Topic; Colonic Neopla	1972
5-Fluorouracil in the treatment of gastrointestinal neoplasia. The New England journal of medicine, 1973, Apr-26, Volume: 288, Issue:17 Topics: Clinical Trials as Topic; Fluorouracil; Gastrointestinal Neoplasms; Humans; Injections, Intravenous	1973
Comparison of treatment of metastatic gastrointestinal cancer with 5-fluorouracil (5-FU) to a combination of 5-FU with cytosine arabinoside. Cancer, 1972, Volume: 29, Issue:5 Topics: Adenocarcinoma; Clinical Trials as Topic; Colonic Neoplasms; Cytarabine; Diabetic Ketoacidosis; Diar	1972
Concurrent combination chemotherapy of human solid tumors: experience with a three-drug regimen and review of the literature. Cancer research, 1969, Volume: 29, Issue:2 Topics: Adolescent; Adult; Aged; Bone Marrow; Bone Neoplasms; Carcinoma; Child; Child, Preschool; Clinical T	1969
Effects of 5-fluorouracil (NSC-19893) in 389 patients with cancer. Eastern Clinical Drug Evaluation Program. Cancer chemotherapy reports, 1968, Volume: 52, Issue:6 Topics: Breast Neoplasms; Clinical Trials as Topic; Female; Fluorouracil; Gastrointestinal Neoplasms; Humans	1968
[Oxytetracycline, vehicle for therapeutic drugs, fluorouracil and nitrogen mustard, in the treatment of gastrointestinal tumors]. Hospital (Rio de Janeiro, Brazil), 1970, Volume: 77, Issue:4 Topics: Adenocarcinoma; Adult; Bile Duct Neoplasms; Clinical Trials as Topic; Drug Combinations; Esophagus;	1970

Intervention	Participants (Count of Participants)
	Complete Response	Partial Response	Stable Disease	Progressive Disease
Cohort A Dose Level A1	0	1	3	4
Cohort A Dose Level A2	0	0	4	4
Cohort C Dose Level C1	0	0	2	6
Cohort C Dose Level C2	0	1	5	10