lomustine and Rectal Neoplasms studies

Research Excerpts

Excerpt	Relevance	Reference
"During adjuvant radiotherapy (RT) for rectal cancer, patients receiving 5-fluorouracil (5-FU) by protracted venous infusion have a higher risk of diarrhea than have patients receiving bolus 5-FU."	5.10	Acute diarrhea during adjuvant therapy for rectal cancer: a detailed analysis from a randomized intergroup trial. ( Cha, SS; Gunderson, LL; Haller, D; Macdonald, JS; Martenson, JA; Mayer, RJ; Miller, RC; O'Connell, MJ; Rich, TA; Sargent, DJ, 2002)
"Every third patient with colon cancer Dukes' C and every fourth patient with rectal cancer Dukes' C survives 5 years."	2.65	[Background and experience of adjuvant cytostatic therapy in gastrointestinal cancer (author's transl)]. ( Bengmark, S; Eriksson, S; Hafström, L; Hugander, A, 1981)
"Forty-six adult patients with colorectal cancer were treated with cyclophosphamide and CCNU administered orally and 5-fluorouracil (5-FU) administered either orally or by continuous iv infusion (FCC-CIF), depending on the availability of hospital beds."	2.64	Chemotherapy for colorectal cancer with 5-fluorouracil, cyclophosphamide, and CCNU: comparison of oral and continuous iv administration of 5-fluorouracil. ( Bedikian, AY; Bodey, GP; Burgess, MA; Livingston, R; Staab, R; Valdivieso, M, 1978)
"Conservative procedures to treat rectal cancer are also gaining support because of reduced morbidity and mortality, avoidance of colostomy, and excellent survival figures in selected patients."	2.38	Surgical therapy of early rectal carcinoma. ( Curley, SA; Rich, TA; Roh, MS, 1989)
"Eighteen adult colorectal cancer patients, previously untreated with systemic chemotherapy, were given CCNU and MISO."	1.27	Evaluation of CCNU and misonidazole in the treatment of advanced colorectal cancer. ( Anagnost, J; Bennett, JM; Boros, L; Mulcahy, RT; Siemann, DW; Sutherland, RM, 1987)
"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)

Research

Studies (36)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Number of Participants With Serious and Non-Serious Adverse Events

Timeframe	Studies, this research(%)	All Research%
pre-1990	35 (97.22)	18.7374
1990's	0 (0.00)	18.2507
2000's	1 (2.78)	29.6817
2010's	0 (0.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Miller, RC	1
Sargent, DJ	1
Martenson, JA	1
Macdonald, JS	1
Haller, D	1
Mayer, RJ	1
Gunderson, LL	1
Rich, TA	2
Cha, SS	1
O'Connell, MJ	1
BERNASCHEK, W	1
Queisser, W	1
Heim, ME	1
Xavier, AM	1
Kasimis, BS	1
Wu, SY	1
Kaneshiro, CA	1
Higgins, GA	1
Gisselbrecht, C	1
Belpomme, D	1
Mignot, L	1
Marty, M	1
Mathé, G	1
Boiron, M	1
White, DR	1
Richards, F	1
Muss, HB	1
Cooper, MR	1
Spurr, CL	1
Bonomi, PD	1
Chandra, G	1
Rossof, AH	1
Klaassen, D	2
Vaughn, CB	1
Chapman, JL	1
Garland, M	1
Pederson, B	1
Demitrish, MM	1
Chinn, B	1
Ward, D	1
Brady, PR	1
Hafström, L	1
Bengmark, S	1
Eriksson, S	1
Hugander, A	1
Foon, KA	1
Haskell, CM	1
Seifart, W	1
Marx, G	1
Barrett, A	1
Gazet, JC	1
Bradbeer, JW	1
Peckham, MJ	1
Hartwich, G	1
Neidhardt, B	1
Hossfeld, DK	1
Moertel, CG	5
Pratt, CB	1
Rivera, G	1
Shanks, E	1
Johnson, WW	1
Howarth, C	1
Terrell, W	1
Kumar, AP	1
Lehnert, M	1
Valdivieso, M	2
Bedikian, A	1
Burgess, MA	2
Rodriguez, V	1
Hersh, EM	1
Bodey, GP	2
Mavligit, GM	1
Bedikian, AY	1
Staab, R	1
Livingston, R	1
Bolton, PM	1
Cedermark, BJ	1
Didolkar, MS	1
Elias, EG	1
Douglass, HO	2
Lavin, PT	1
Hill, GJ	1
Johnson, RO	1
Metter, G	1
Wilson, WL	1
Davis, HL	1
Grage, T	1
Fletcher, WS	1
Golomb, FM	1
Cruz, AB	1
Wasserman, TH	1
Slavik, M	1
Carter, SK	2
Curley, SA	1
Roh, MS	1
MacIntyre, JM	1
Kaufman, J	1
Von Hoff, D	1
Engstrom, PF	1
Anagnost, J	1
Bennett, JM	1
Sutherland, RM	1
Boros, L	1
Siemann, DW	1
Mulcahy, RT	1
Presant, CA	1
Kennedy, P	1
Wiseman, C	1
Gala, K	1
Smith, JD	1
Bouzaglou, A	1
Farbstein, M	1
Multhauf, P	1
Bertrand, M	1
Green, L	1
Platinskiĭ, LV	1
Sokolova, VD	1
Ozhiganov, EL	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Phase I Trial of 5-Fluoro-2'-Deoxycytidine With Tetrahydrouridine[NCT00359606]	Phase 1	58 participants (Actual)	Interventional	1999-04-30	Completed
Phase 0 Trial of [F-18]-5-Fluoro-2'-Deoxycytidine With Tetrahydrouridine[NCT01479348]	Early Phase 1	5 participants (Actual)	Interventional	2011-11-01	Terminated (stopped due to Slow, insufficient accrual.)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Here is the number 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. (NCT01479348)
Timeframe: Date treatment consent signed to date off study, approximately 20 months and 12 days.

Frequency and Severity of Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Intervention	Participants (Count of Participants)
1/Intravenous (IV) Tetrahydrouridine (THU)	2

[F-18]-5-fluoro-2'-deoxycytidine (FdCyd) was administered intravenously with administration of tetrahydrouridine (THU) and the frequency and severity of adverse events was observed. 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. Grade 0 is normal, Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe or medically significant but not immediately life-threatening, Grade 4 is life-threatening consequences, and Grade 5 is death related to adverse event. (NCT01479348)
Timeframe: Within 5 days after interventions

Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans

Intervention	adverse events (Number)
	Day 1 Adverse Events	Day 2, Grade 2 Hypoalbuminemia	Day 2, Grade 3 Anemia	Day 3 Adverse Events	Day 4 Adverse Events	Day 5 Adverse Events
1/Intravenous (IV) Tetrahydrouridine (THU)	0	1	1	0	0	0

Radiation dosimetry was determined based on the first patients. This involved making region of interest measurements on the scan for each major organ and measuring the uptake. Using standard dosimetry software this is converted into mSv/MBq, a standard measure of dosimetry. The software is known as Organ Level INternal Dose Assessment/EXponential Modeling (OLINDA) and is commonly used to generate this kind of data. (NCT01479348)
Timeframe: 1 year

Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection

Intervention	mSv/MBq (Mean)
	Adrenals	Brain	Breasts	Gallbladder wall	Lower large intestine wall	Small intestine	Stomach wall	Upper large intestine wall	Heart wall	Kidneys	Liver	Lungs	Muscle	Ovaries	Pancreas	Red marrow	Osteogenic cells	Skin	Spleen	Testes	Thymus	Thyroid	Urinary bladder wall	Uterus
1/Intravenous (IV) Tetrahydrouridine (THU)	1.83	8.17	1.03	4.05	2.52	2.13	1.90	2.04	1.10	5.26	6.02	1.82	1.16	1.57	1.63	1.14	1.71	8.65	1.69	1.03	1.12	8.23	7.96	1.63

Participants were scanned by positron emission tomography (PET) and lesions were measured at 4 time points after injection. (NCT01479348)
Timeframe: 9 minutes, 32 minutes, 56 minutes and 2 hours after injection

Intervention	TBR ratio (Number)
	Pt 1 L. Parotid adenosquam. cell ca at 9 min	Pt 1 L. Parotid adenosquam. cell ca at 32 min	Pt 1 L. Parotid adenosquam. cell ca at 56 min	Pt 1 L. Parotid adenosquam. cell ca at 2 hrs	Pt 2 R. Parapharyngeal Spindle Cell Ca at 9 min	Pt 2 R. Parapharyngeal Spindle Cell Ca at 32 min	Pt 2 R. Parapharyngeal Spindle Cell Ca at 56 min	Pt 2 R. Parapharyngeal Spindle Cell Ca at 2 hrs	Pt 3 Non-small Cell Lung Ca at 9 min	Pt 3 Non-small Cell Lung Ca at 32 min	Pt 3 Non-small Cell Lung Ca at 56 min	Pt 3 Non-small Cell Lung Ca at 2 hrs	Pt 4 Non-small Cell Lung Ca at 9 min	Pt 4 Non-small Cell Lung Ca at 32 min	Pt 4 Non-small Cell Lung Ca at 56 min	Pt 4 Non-small Cell Lung Ca at 2 hrs	Pt 5 Hepatocellular Ca at 9 min	Pt 5 Hepatocellular Ca at 32 min	Pt 5 Hepatocellular Ca at 56 min	Pt 5 Hepatocellular Ca at 2 hrs
1/Intravenous (IV) Tetrahydrouridine (THU)	1.4	1.5	1.5	1.6	1.9	1.7	1.7	1.6	1.4	1.4	1.5	1.7	2.4	2.1	1.6	2.0	NA	NA	NA	NA

Article	Year
Chemotherapy in alimentary tract malignomas. Hepato-gastroenterology, 1981, Volume: 28, Issue:5 Topics: Antibiotics, Antineoplastic; Antineoplastic Agents; Carmustine; Colonic Neoplasms; Cytarabine; Doxor	1981
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
Clinical comparison of the nitrosoureas. Cancer, 1975, Volume: 36, Issue:4 Topics: Animals; Antineoplastic Agents; Brain Neoplasms; Breast Neoplasms; Carmustine; Chemical Phenomena; C	1975
Surgical therapy of early rectal carcinoma. Hematology/oncology clinics of North America, 1989, Volume: 3, Issue:1 Topics: Antineoplastic Combined Chemotherapy Protocols; Brachytherapy; Combined Modality Therapy; Fluorourac	1989
[Chemotherapy of cancer of the large intestine]. Sovetskaia meditsina, 1985, Issue:3 Topics: Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Carmustine; Colonic Neoplasms	1985

Article	Year
Acute diarrhea during adjuvant therapy for rectal cancer: a detailed analysis from a randomized intergroup trial. International journal of radiation oncology, biology, physics, 2002, Oct-01, Volume: 54, Issue:2 Topics: Acute Disease; Antineoplastic Combined Chemotherapy Protocols; Diarrhea; Fluorouracil; Humans; Infus	2002
Combination chemotherapy with 5-fluorouracil, CCNU, and vincristine in metastatic colorectal carcinoma. American journal of clinical oncology, 1984, Volume: 7, Issue:5 Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Clinical Trials as Topic; Colonic Neopl	1984
Therapy of advanced colorectal carcinoma with 5-fluorouracil and cyclophosphamide in combination with either CCNU or methotrexate. Cancer, 1980, Feb-15, Volume: 45, Issue:4 Topics: Adenocarcinoma; Antineoplastic Agents; Clinical Trials as Topic; Colonic Neoplasms; Cyclophosphamide	1980
MItomycin C, methyl-CCNU and 5-fluorouracil in the treatment of metastatic colorectal carcinoma. Cancer chemotherapy and pharmacology, 1980, Volume: 5, Issue:1 Topics: Adult; Aged; Clinical Trials as Topic; Colonic Neoplasms; Drug Therapy, Combination; Fluorouracil; F	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
[Background and experience of adjuvant cytostatic therapy in gastrointestinal cancer (author's transl)]. Zentralblatt fur Chirurgie, 1981, Volume: 106, Issue:19 Topics: Antineoplastic Agents; Clinical Trials as Topic; Colonic Neoplasms; Drug Therapy, Combination; Fluor	1981
Chemotherapy for colorectal cancer with 5-fluorouracil, cyclophosphamide, and CCNU: comparison of oral and continuous iv administration of 5-fluorouracil. Cancer treatment reports, 1978, Volume: 62, Issue:10 Topics: Administration, Oral; Adult; Clinical Trials as Topic; Colonic Neoplasms; Cyclophosphamide; Drug Eva	1978
Methyl-CCNU (NSC-95441) in advanced colorectal carcinoma after failure of 5-fluorouracil (NSC-19893) therapy. Cancer treatment reports, 1976, Volume: 60, Issue:3 Topics: Adenocarcinoma; Adult; Aged; Blood Platelet Disorders; Clinical Trials as Topic; Colonic Neoplasms;	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
Eastern Cooperative Oncology Group phase II studies in advanced measurable colorectal cancer. I. Razoxane, Yoshi-864, piperazinedione, and lomustine. Cancer treatment reports, 1985, Volume: 69, Issue:5 Topics: Antibiotics, Antineoplastic; Antineoplastic Agents; Colonic Neoplasms; Drug Evaluation; Humans; Lomu	1985

Article	Year
[Plea for the Babcock-Bacon operation; presentation of cases]. Bordeaux chirurgical, 1952, Volume: 2 Topics: Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Doxorubicin; Humans; Lomustine; Mechloret	1952
[Sphincter protection by means of a sponge rubber prosthesis in Bacon's radical operation for rectal carcinoma]. Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen, 1953, Volume: 24, Issue:4 Topics: Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Doxorubicin; Humans; Lomustine; Mechloret	1953
[Indications for the Babcock-Bacon operation]. Bordeaux chirurgical, 1952, Volume: 1 Topics: Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Colonic Neoplasms; Doxorubicin; Humans; L	1952
Adjuvant therapy for carcinoma of the colon and rectum. International advances in surgical oncology, 1984, Volume: 7 Topics: Antineoplastic Agents; Colonic Neoplasms; Combined Modality Therapy; Female; Fluorouracil; Humans; L	1984
Chemotherapy of carcinomas of the digestive tract. Recent results in cancer research. Fortschritte der Krebsforschung. Progres dans les recherches sur le cancer, 1982, Volume: 80 Topics: Antineoplastic Agents; Cisplatin; Colonic Neoplasms; Doxorubicin; Drug Administration Schedule; Esop	1982
Inadvertent overdose with lomustine (CCNU) followed by hematologic recovery. Cancer treatment reports, 1982, Volume: 66, Issue:5 Topics: Bone Marrow; Humans; Lomustine; Male; Middle Aged; Nitrosourea Compounds; Rectal Neoplasms	1982
[Results of surgical and complex treatment of colonic and rectal cancer]. Archiv fur Geschwulstforschung, 1982, Volume: 52, Issue:6 Topics: Colectomy; Colonic Neoplasms; Cyclophosphamide; Fluorouracil; Humans; Lomustine; Neoplasm Staging; P	1982
Failure of methyl-C.C.N.U. and 5-fluorouracil in colorectal cancer. Lancet (London, England), 1978, Jul-08, Volume: 2, Issue:8080 Topics: Adult; Aged; Colonic Neoplasms; Dacarbazine; Drug Evaluation; Drug Therapy, Combination; Female; Flu	1978
[Chemotherapy of colorectal carcinomas]. Deutsche medizinische Wochenschrift (1946), 1978, Sep-22, Volume: 103, Issue:38 Topics: Adenocarcinoma; Colonic Neoplasms; Drug Therapy, Combination; Fluorouracil; Humans; Lomustine; Palli	1978
[The state of chemotherapy of colorectal neoplasms]. Zeitschrift fur Gastroenterologie. Verhandlungsband, 1978, Issue:14 Topics: Antineoplastic Agents; Colonic Neoplasms; Drug Therapy, Combination; Fluorouracil; Humans; Lomustine	1978
Clinical management of advanced gastrointestinal cancer. Cancer, 1975, Volume: 36, Issue:2 Topics: Adenoma, Islet Cell; Carcinoma, Hepatocellular; Carmustine; Colonic Neoplasms; Cytarabine; Drug Ther	1975
Walter Hubert lecture Chemotherapy of upper gastrointestinal carcinoma. British journal of cancer, 1976, Volume: 34, Issue:3 Topics: Adenoma, Islet Cell; Antineoplastic Agents; Carcinoid Tumor; Carcinoma, Hepatocellular; Carcinoma, S	1976
Colorectal carcinoma in adolescents implications regarding etiology. Cancer, 1977, Volume: 40, Issue:5 Suppl Topics: Adenocarcinoma, Mucinous; Adolescent; Adult; Child; Colonic Neoplasms; Female; Fluorouracil; Humans;	1977
[Status and problems of the treatment of metastatic rectal cancer]. Acta medica Austriaca. Supplement, 1979, Volume: 6 Topics: Antineoplastic Agents; Drug Therapy, Combination; Fluorouracil; Humans; Lomustine; Neoplasm Recurren	1979
Chemoimmunotherapy of metastatic large bowel cancer: nonspecific stimulation with BCG and levamisole. Cancer, 1977, Volume: 40, Issue:5 Suppl Topics: BCG Vaccine; Colonic Neoplasms; Drug Therapy, Combination; Fluorouracil; Humans; Levamisole; Lomusti	1977
Chemotherapy, immunotherapy and chemoimmunotherapy of colorectal cancer. Australasian radiology, 1977, Volume: 21, Issue:4 Topics: Colonic Neoplasms; Fluorouracil; Humans; Immunotherapy; Lomustine; Methotrexate; Mitomycins; Rectal	1977
Multimodal surgical adjuvant therapy for a broad spectrum of tumors in humans.? Surgery, gynecology & obstetrics, 1976, Volume: 142, Issue:6 Topics: Adult; Altretamine; Antineoplastic Agents; Bone Neoplasms; Breast Neoplasms; Carmustine; Colonic Neo	1976
Gastrointestinal cancer. Treatment with fluorouracil-nitrosourea combinations. JAMA, 1976, May-10, Volume: 235, Issue:19 Topics: Carmustine; Colonic Neoplasms; Drug Therapy, Combination; Female; Fluorouracil; Gastrointestinal Neo	1976
Editorial: Large-bowel cancer-The current status of treatment. Journal of the National Cancer Institute, 1976, Volume: 56, Issue:1 Topics: Adjuvants, Immunologic; BCG Vaccine; Carmustine; Colonic Neoplasms; Doxorubicin; Drug Therapy, Combi	1976
Editorial: Large-bowel cancer-The current status of treatment. Journal of the National Cancer Institute, 1976, Volume: 56, Issue:1 Topics: Adjuvants, Immunologic; BCG Vaccine; Carmustine; Colonic Neoplasms; Doxorubicin; Drug Therapy, Combi	1976
Editorial: Large-bowel cancer-The current status of treatment. Journal of the National Cancer Institute, 1976, Volume: 56, Issue:1 Topics: Adjuvants, Immunologic; BCG Vaccine; Carmustine; Colonic Neoplasms; Doxorubicin; Drug Therapy, Combi	1976
Editorial: Large-bowel cancer-The current status of treatment. Journal of the National Cancer Institute, 1976, Volume: 56, Issue:1 Topics: Adjuvants, Immunologic; BCG Vaccine; Carmustine; Colonic Neoplasms; Doxorubicin; Drug Therapy, Combi	1976
Evaluation of CCNU and misonidazole in the treatment of advanced colorectal cancer. American journal of clinical oncology, 1987, Volume: 10, Issue:3 Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Colonic Neoplasms; Drug Evaluation; Fem	1987
Pilot phase II trial of amphotericin B and CCNU in renal and colorectal carcinomas. European journal of cancer & clinical oncology, 1986, Volume: 22, Issue:3 Topics: Amphotericin B; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Renal Cell; Colonic Neopl	1986

lomustine and Rectal Neoplasms