mitoxantrone and Adenocarcinoma studies

Mitoxantrone: An anthracenedione-derived antineoplastic agent.
mitoxantrone : A dihydroxyanthraquinone that is 1,4-dihydroxy-9,10-anthraquinone which is substituted by 6-hydroxy-1,4-diazahexyl groups at positions 5 and 8.

Research Excerpts

Excerpt	Relevance	Reference
"Mitoxantrone (MTZ) and vinorelbine (VNR) have shown a good efficacy in advanced breast cancer."	9.08	Mitoxantrone plus vinorelbine with granulocyte-colony stimulating factor (G-CSF) support in advanced breast cancer patients. A dose and schedule finding study. ( Comella, G; Comella, P; Cremone, L; Della Volpe, N; Frasci, G; Imbriani, A; Persico, G; Salzano, F, 1995)
"Four hundred eleven women with metastatic breast cancer were randomly assigned to receive either 60 mg/m2 doxorubicin (130 patients), 320 mg/m2 bisantrene (146 patients), or 14 mg/m2 mitoxantrone (135 patients)."	9.07	Randomized trial of doxorubicin, bisantrene, and mitoxantrone in advanced breast cancer: a Southwest Oncology Group study. ( Coltman, CA; Cowan, JD; Gumbart, C; Hutchins, LF; Martino, S; McClure, S; Neidhart, J; Osborne, CK; Stephens, RL; Vaughan, CB, 1991)
"We have studied a mitoxantrone, 5-fluorouracil (5-FU) and leucovorin chemotherapy regimen in metastatic breast cancer."	9.07	The importance of dose scheduling with mitoxantrone, 5-fluorouracil and leucovorin in metastatic breast cancer. ( Bélanger, K; Dionne, J; Gagné, L; Guévin, R; Jolivet, J; Latreille, J; Potvin, M; Rudinskas, L; Wilson, J; Yelle, L, 1994)
"A dose-finding investigation was conducted with mitoxantrone administered as 14-day continuous infusions to patients with hormone-refractory metastatic adenocarcinoma of the prostate."	9.07	14-Day continuous infusion of mitoxantrone in hormone-refractory metastatic adenocarcinoma of the prostate. ( Block, C; George, M; Kantoff, PW; Letvak, L, 1993)
"To determine the safety and efficacy of mitoxantrone use in hyperbilirubinemic breast cancer patients, a prospectively determined dosage schedule was evaluated in a multi-center trial."	9.06	Mitoxantrone use in breast cancer patients with elevated bilirubin. ( Bulcavage, L; Chlebowski, RT; Elashoff, R; Henderson, IC; Rivest, R; Woodcock, T, 1989)
"Three hundred twenty-five women with metastatic adenocarcinoma of the breast who had failed one prior chemotherapeutic regimen for advanced disease were randomized to receive 14 mg/m2 of mitoxantrone or 75 mg/m2 of doxorubicin intravenously (IV) every 3 weeks."	9.06	Randomized clinical trial comparing mitoxantrone with doxorubicin in previously treated patients with metastatic breast cancer. ( Allegra, JC; Bryan, S; Cartwright, K; Dukart, G; Henderson, IC; Henry, D; Wolff, S; Woodcock, T, 1989)
"Breast cancer resistance protein (BCRP/ABCG2), an ATP-binding cassette half transporter, confers multidrug resistance (MDR) to a series of antitumor agents such as mitoxantrone, daunorubicin, SN-38, and topotecan, and often limits the efficacy of chemotherapy."	7.76	Transcriptional modulation of BCRP gene to reverse multidrug resistance by toremifene in breast adenocarcinoma cells. ( Gao, P; Gao, Y; Li, G; Wang, H; Wei, F; Wei, L; Yin, D; Yu, J; Zhang, X; Zhang, Y; Zhou, G, 2010)
"Eighteen patients (17 evaluable for response) with metastatic breast cancer were treated with mitoxantrone 10 mg/m2 day 1, followed by 5-fluorouracil 375 mg/m2 day 1-5, and high-dose leucovorin 500 mg/m2 day 1-5 given every 28 days."	7.69	Mitoxantrone, 5-FU, and leucovorin in breast cancer. ( Honig, SF; Swain, SM, 1994)
"The toxicity of escalating doses of liposome-complexed mitoxantrone (LCM) was evaluated in 22 women with histological/cytological diagnosis of metastatic breast cancer (21 pts) or adenocarcinoma of unknown primary origin (1 pt)."	7.68	Phase I/II study of liposome-complexed mitoxantrone in patients with advanced breast cancer. ( Pestalozzi, B; Sauter, C; Schwendener, R, 1992)
"Twenty-three patients with advanced breast cancer were treated with the combination of mitoxantrone and doxorubicin."	7.67	Combined mitoxantrone plus doxorubicin in the treatment of breast cancer. ( Lefebvre, BM; Maroun, JA; Perrault, DJ; Stewart, DJ, 1987)
"Twenty-five evaluable patients with advanced non-squamous carcinoma of the uterine cervix were treated with mitoxantrone 12 mg/m2 every three weeks."	7.67	Mitoxantrone in the treatment of advanced non-squamous carcinoma of the cervix (a phase II trial of the gynecologic oncology group). ( Bundy, BN; Homesley, HD; Muss, HB; Wilbanks, G, 1987)
"In January 2007, SWOG 9921 was closed to further accrual after three cases of acute myelogenous leukemia (AML) were reported of a total of 487 patients in the mitoxantrone treatment arm."	5.13	Randomization reveals unexpected acute leukemias in Southwest Oncology Group prostate cancer trial. ( Crawford, ED; Flaig, TW; Glodé, LM; Hussain, MH; Raghavan, D; Stadler, WM; Tangen, CM, 2008)
"Mitoxantrone (MTZ) and vinorelbine (VNR) have shown a good efficacy in advanced breast cancer."	5.08	Mitoxantrone plus vinorelbine with granulocyte-colony stimulating factor (G-CSF) support in advanced breast cancer patients. A dose and schedule finding study. ( Comella, G; Comella, P; Cremone, L; Della Volpe, N; Frasci, G; Imbriani, A; Persico, G; Salzano, F, 1995)
"We randomized 161 hormone-refractory patients with pain to receive mitoxantrone plus prednisone or prednisone alone (10 mg daily)."	5.08	Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points. ( Armitage, GR; Coppin, CM; Ernst, DS; Moore, MJ; Murphy, KC; Neville, AJ; Osoba, D; Stockler, MR; Tannock, IF; Venner, PM; Wilson, JJ, 1996)
"Four hundred eleven women with metastatic breast cancer were randomly assigned to receive either 60 mg/m2 doxorubicin (130 patients), 320 mg/m2 bisantrene (146 patients), or 14 mg/m2 mitoxantrone (135 patients)."	5.07	Randomized trial of doxorubicin, bisantrene, and mitoxantrone in advanced breast cancer: a Southwest Oncology Group study. ( Coltman, CA; Cowan, JD; Gumbart, C; Hutchins, LF; Martino, S; McClure, S; Neidhart, J; Osborne, CK; Stephens, RL; Vaughan, CB, 1991)
"We have studied a mitoxantrone, 5-fluorouracil (5-FU) and leucovorin chemotherapy regimen in metastatic breast cancer."	5.07	The importance of dose scheduling with mitoxantrone, 5-fluorouracil and leucovorin in metastatic breast cancer. ( Bélanger, K; Dionne, J; Gagné, L; Guévin, R; Jolivet, J; Latreille, J; Potvin, M; Rudinskas, L; Wilson, J; Yelle, L, 1994)
"A dose-finding investigation was conducted with mitoxantrone administered as 14-day continuous infusions to patients with hormone-refractory metastatic adenocarcinoma of the prostate."	5.07	14-Day continuous infusion of mitoxantrone in hormone-refractory metastatic adenocarcinoma of the prostate. ( Block, C; George, M; Kantoff, PW; Letvak, L, 1993)
"From April 1990 to April 1992, a comparative study was carried out in 46 patients with advanced breast cancer treated by CMxMF (Cyclophosphamide, mitoxantrone, methotrexate, 5-fluorouracil) and CAMF regimens (Cyclophosphamide, adriamycin, methotrexate, 5-fluorouracil)."	5.07	[Comparison of the therapeutic effect of CMxMF and CAMF regimens in the management of advanced breast cancer patients]. ( Chen, JA, 1993)
"Three hundred twenty-five women with metastatic adenocarcinoma of the breast who had failed one prior chemotherapeutic regimen for advanced disease were randomized to receive 14 mg/m2 of mitoxantrone or 75 mg/m2 of doxorubicin intravenously (IV) every 3 weeks."	5.06	Randomized clinical trial comparing mitoxantrone with doxorubicin in previously treated patients with metastatic breast cancer. ( Allegra, JC; Bryan, S; Cartwright, K; Dukart, G; Henderson, IC; Henry, D; Wolff, S; Woodcock, T, 1989)
"Sixteen patients with advanced adenocarcinoma of the stomach were entered into a phase II study of mitoxantrone at a dosage of either 12 mg/m2 or 14 mg/m2 given at 3 weekly intervals."	5.06	A phase II study of mitoxantrone in advanced gastric cancer. ( Gill, PG; Levi, JA; Presgrave, P, 1990)
"Patient with advanced adenocarcinoma of the pancreas and no prior chemotherapy were treated on a Phase II trial of mitoxantrone."	5.06	Phase II evaluation of mitoxantrone in advanced pancreatic carcinoma: a Southwest Oncology Group study. ( Bukowski, RM; Costanzi, JH; Fleming, T; Guy, JT; McCracken, JD; Natale, RB; Samlowski, WE; Talley, RW; Taylor, SA; Von Hoff, DD, 1990)
"To determine the safety and efficacy of mitoxantrone use in hyperbilirubinemic breast cancer patients, a prospectively determined dosage schedule was evaluated in a multi-center trial."	5.06	Mitoxantrone use in breast cancer patients with elevated bilirubin. ( Bulcavage, L; Chlebowski, RT; Elashoff, R; Henderson, IC; Rivest, R; Woodcock, T, 1989)
" As a result, mitoxantrone plus prednisone has been demonstrated to be a useful palliative therapy that provides improvements in pain and quality of life for approximately 40% of those treated."	4.81	Treatment of hormone refractory prostate cancer. ( Knox, JJ; Moore, MJ, 2001)
"Breast cancer resistance protein (BCRP/ABCG2), an ATP-binding cassette half transporter, confers multidrug resistance (MDR) to a series of antitumor agents such as mitoxantrone, daunorubicin, SN-38, and topotecan, and often limits the efficacy of chemotherapy."	3.76	Transcriptional modulation of BCRP gene to reverse multidrug resistance by toremifene in breast adenocarcinoma cells. ( Gao, P; Gao, Y; Li, G; Wang, H; Wei, F; Wei, L; Yin, D; Yu, J; Zhang, X; Zhang, Y; Zhou, G, 2010)
"In this study, we aimed to evaluate the influence of proinflammatory cytokines on ABCG2 expression and function in human MCF-7 breast cancer cell line and its mitoxantrone-resistant derivative MCF-7/MX."	3.75	Interleukin-1 beta and tumor necrosis factor-alpha increase ABCG2 expression in MCF-7 breast carcinoma cell line and its mitoxantrone-resistant derivative, MCF-7/MX. ( Afshari, JT; Behravan, J; Lage, H; Mosaffa, F, 2009)
" The pericardial effusion recurred and was then successfully treated with intrapericardial mitoxantrone."	3.74	Malignant pericardial effusion secondary to ovarian adenocarcinoma: a case report. ( Brown, JV; Epstein, HD; Goldstein, BH; Micha, JP; Rettenmaier, MA; Zusman, D, 2007)
"Eighteen patients (17 evaluable for response) with metastatic breast cancer were treated with mitoxantrone 10 mg/m2 day 1, followed by 5-fluorouracil 375 mg/m2 day 1-5, and high-dose leucovorin 500 mg/m2 day 1-5 given every 28 days."	3.69	Mitoxantrone, 5-FU, and leucovorin in breast cancer. ( Honig, SF; Swain, SM, 1994)
"The toxicity of escalating doses of liposome-complexed mitoxantrone (LCM) was evaluated in 22 women with histological/cytological diagnosis of metastatic breast cancer (21 pts) or adenocarcinoma of unknown primary origin (1 pt)."	3.68	Phase I/II study of liposome-complexed mitoxantrone in patients with advanced breast cancer. ( Pestalozzi, B; Sauter, C; Schwendener, R, 1992)
"Twenty-three patients with advanced breast cancer were treated with the combination of mitoxantrone and doxorubicin."	3.67	Combined mitoxantrone plus doxorubicin in the treatment of breast cancer. ( Lefebvre, BM; Maroun, JA; Perrault, DJ; Stewart, DJ, 1987)
"Twenty-five evaluable patients with advanced non-squamous carcinoma of the uterine cervix were treated with mitoxantrone 12 mg/m2 every three weeks."	3.67	Mitoxantrone in the treatment of advanced non-squamous carcinoma of the cervix (a phase II trial of the gynecologic oncology group). ( Bundy, BN; Homesley, HD; Muss, HB; Wilbanks, G, 1987)
"Disease recurrence was defined as a confirmed serum prostate-specific antigen (PSA) >0."	2.75	Phase 1/2 study of preoperative docetaxel and mitoxantrone for high-risk prostate cancer. ( Beer, TM; Fazli, L; Garzotto, M; Higano, CS; Janeba, N; Lange, PH; Lieberman, S; O'Brien, C; Rademacher, BL, 2010)
"In patients with pancreatic cancer, CAI/RT had no significant effect on local recurrence (log-rank P = 0."	2.73	Adjuvant intra-arterial chemotherapy and radiotherapy versus surgery alone in resectable pancreatic and periampullary cancer: a prospective randomized controlled trial. ( Hermans, JJ; Hop, WC; Incrocci, L; Jeekel, J; Kazemier, G; Morak, MJ; van Dekken, H; van der Gaast, A; van Eijck, CH, 2008)
"To evaluate the preliminary efficacy, safety, and impact on quality of life (QoL) of high-dose calcitriol (DN-101) combined with mitoxantrone and glucocorticoids in androgen-independent prostate cancer (AIPC)."	2.73	A phase II study of high-dose calcitriol combined with mitoxantrone and prednisone for androgen-independent prostate cancer. ( Beer, TM; Chan, JS; Dehaze, DR; Garzotto, M; Pinski, JK; Quinn, DI; Ryan, CW; Sokoloff, M, 2008)
"Mitoxantrone has been approved by the Food and Drug Administration for HRCAP."	2.71	Phase II trial of tesmilifene plus mitoxantrone and prednisone for hormone refractory prostate cancer: high subjective and objective response in patients with symptomatic metastases. ( Brandes, LJ; Klapp, K; Lieskovsky, G; Quinn, DI; Raghavan, D; Ramsey, EW; Snyder, T; Styles, E; Tsao-Wei, D, 2005)
"Docetaxel, a taxane previously approved for the treatment of breast cancer and non-small cell lung cancer, was approved by the United States Food and Drug Administration on May 19, 2004 for use in combination with prednisone for the treatment of metastatic androgen-independent (hormone-refractory) prostate cancer."	2.71	Approval summary: Docetaxel in combination with prednisone for the treatment of androgen-independent hormone-refractory prostate cancer. ( Abraham, S; Dagher, R; Li, N; Pazdur, R; Rahman, A; Sridhara, R, 2004)
"Patients with hormone refractory prostate cancer who are asymptomatic but had progressive disease had a significantly higher response rate when treated with mitoxantrone and prednisone as demonstrated by the 50% or greater decrease in prostate specific antigen compared to treatment with prednisone alone."	2.70	Phase III study of mitoxantrone plus low dose prednisone versus low dose prednisone alone in patients with asymptomatic hormone refractory prostate cancer. ( Asmar, L; Berry, W; Dakhil, S; Gregurich, M; Modiano, M, 2002)
"Treatment with mitoxantrone plus prednisone was associated with greater and longer-lasting improvement in several HQL domains and symptoms than treatment with prednisone alone."	2.69	Health-related quality of life in men with metastatic prostate cancer treated with prednisone alone or mitoxantrone and prednisone. ( Ernst, DS; Neville, AJ; Osoba, D; Tannock, IF, 1999)
"Mitomycin C was infused over 25 minutes followed by 5-FU over 10 minutes."	2.68	Regional chemotherapy for inoperable pancreatic carcinoma. ( George, WJ; Muchmore, JH; Preslan, JE, 1996)
"Although their ultimate value in prostate cancer therapy remains to be defined in randomized trials, docetaxel and paclitaxel are active agents in HRPC."	2.41	Paclitaxel and docetaxel in prostate cancer. ( Hudes, GR; Obasaju, C, 2001)
"Prostate cancer is perceived to be a disease of older men often diagnosed with widespread metastases that respond to hormonal ablation but for which there are few additional treatment options."	2.41	Can chemotherapy alter the course of prostate cancer? ( Haas, NB, 2001)
"To date, all available therapies for prostate cancer are plagued by adverse effects."	2.41	Complications of chemotherapy for prostate cancer. ( Beer, TM; Bubalo, JS, 2001)
"Locally advanced, fungating breast cancers pose particularly difficult management problems for which intra-arterial drug delivery may be appropriate in carefully, selected cases."	2.39	Intra-arterial chemotherapy for palliation of fungating breast cancer. A case report and review of the literature. ( Bufill, JA; Grace, WR; Neff, R, 1994)
"Several severe adverse event clusters were identified in patients with advanced prostate cancer."	1.43	Identifying Severe Adverse Event Clusters Using the National Cancer Institute's Common Terminology Criteria for Adverse Events. ( Hershman, DL; Lee, SM; Lim, EA; Moinpour, CM; Unger, J; Zhong, X, 2016)
"For 13 (93%) of them, circulating tumor cells were detectable during the time of PSA response, i."	1.32	Quantification of disseminated tumor cells in the bloodstream of patients with hormone-refractory prostate carcinoma undergoing cytotoxic chemotherapy. ( Bilkenroth, U; Froehner, M; Fuessel, S; Kraemer, K; Linné, C; Meye, A; Schmidt, U; Wirth, MP, 2004)
"Sporadic breast carcinomas demonstrate microsatellite instability, reflecting the presence of DNA mismatch repair-deficient cells, in about one fourth of cases at the time of diagnosis."	1.31	Resistance to topoisomerase poisons due to loss of DNA mismatch repair. ( Carpini, RD; Fedier, A; Fink, D; Haller, U; Schwarz, VA; Walt, H, 2001)
"Hormone-refractory prostate cancer is the terminal step in the natural history of prostate cancer."	1.30	Docetaxel (Taxotere) and estramustine versus mitoxantrone and prednisone for hormone-refractory prostate cancer: scientific basis and design of Southwest Oncology Group Study 9916. ( Crawford, D; Fisher, E; Hussain, M; Petrylak, D; Tangen, C, 1999)
"Invest, 101: 344-352, 1998) to suppress pancreatic cancer cell growth and increase cytotoxic actions of cisplatinum."	1.30	Inhibition of cyclin D1 expression in human pancreatic cancer cells is associated with increased chemosensitivity and decreased expression of multiple chemoresistance genes. ( Arber, N; Beger, HG; Danenberg, KD; Danenberg, PV; Korc, M; Kornmann, M, 1999)
"In the MCF-7 human breast cancer cell line and in the MCF-7/CP (CDDP resistant) subline, U73-975 and mitoxantrone were both potent cytotoxic agents (IC50 0."	1.28	Combination of the minor groove-binder U73-975 or the intercalator mitoxantrone with antitumor alkylating agents in MCF-7 or MCF-7/CP cells. ( Ayash, L; Herman, TS; Korbut, T; Teicher, BA, 1991)
"Thirty-seven patients with metastatic prostate cancer refractory to endocrine therapy were treated in a phase II trial of mitoxantrone."	1.27	Mitoxantrone: modest activity in a phase II trial in advanced prostate cancer. ( Crawford, ED; Drelichman, A; Osborne, CK; Von Hoff, DD, 1983)
"Mitoxantrone was administered to 12 patients with advanced or recurrent endometrial carcinoma of whom only 1 had received prior chemotherapy (chlorambucil)."	1.27	Phase II study of mitoxantrone in advanced or metastatic endometrial carcinoma. ( Boadle, DJ; Tattersall, MH, 1987)

Research

Studies (97)

Authors

Clinical Trials (26)

Trial Overview

Trial Outcomes

Composite Progression-free Survival (cPFS)

Timeframe	Studies, this research(%)	All Research%
pre-1990	20 (20.62)	18.7374
1990's	30 (30.93)	18.2507
2000's	34 (35.05)	29.6817
2010's	12 (12.37)	24.3611
2020's	1 (1.03)	2.80

Authors	Studies
Krapcho, AP	2
Petry, ME	1
Getahun, Z	1
Landi, JJ	1
Stallman, J	1
Polsenberg, JF	1
Gallagher, CE	2
Maresch, MJ	1
Hacker, MP	2
Giuliani, FC	2
Menta, E	1
Oliva, A	1
Di Domenico, R	1
Fiocchi, L	1
Maresch, ME	1
Beggiolin, G	1
Pezzoni, G	1
Spinelli, S	1
Wu, KJ	1
Zhong, HJ	1
Li, G	2
Liu, C	1
Wang, HD	1
Ma, DL	1
Leung, CH	1
Baltes, F	1
Caspers, J	1
Henze, S	1
Schlesinger, M	1
Bendas, G	1
van Soest, RJ	1
de Morrée, ES	1
Shen, L	1
Tannock, IF	5
Eisenberger, MA	2
de Wit, R	3
Zhou, T	1
Zeng, SX	1
Ye, DW	2
Wei, Q	1
Zhang, X	2
Huang, YR	1
Ye, ZQ	1
Yang, Y	1
Zhang, W	2
Tian, Y	1
Zhou, FJ	1
Jie, J	1
Chen, SP	1
Sun, Y	1
Xie, LP	1
Yao, X	1
Na, YQ	1
Sun, YH	1
Hussain, M	2
Rathkopf, D	1
Liu, G	1
Armstrong, A	1
Kelly, WK	2
Ferrari, A	1
Hainsworth, J	1
Joshi, A	1
Hozak, RR	1
Yang, L	1
Schwartz, JD	1
Higano, CS	3
Zhong, X	1
Lim, EA	1
Hershman, DL	1
Moinpour, CM	1
Unger, J	1
Lee, SM	1
Bergstrom, CP	1
Ruffell, B	1
Ho, CM	1
Ellis, WJ	1
Garzotto, M	3
Beer, TM	6
Graff, JN	1
Chan, JS	1
Quinn, DI	2
Pinski, JK	1
Sokoloff, M	1
Dehaze, DR	1
Ryan, CW	1
Morak, MJ	1
van der Gaast, A	1
Incrocci, L	1
van Dekken, H	1
Hermans, JJ	1
Jeekel, J	1
Hop, WC	1
Kazemier, G	1
van Eijck, CH	1
Mosaffa, F	1
Lage, H	1
Afshari, JT	1
Behravan, J	1
Zhang, Y	1
Wang, H	1
Wei, L	1
Yu, J	1
Gao, Y	1
Gao, P	1
Wei, F	1
Yin, D	1
Zhou, G	1
O'Brien, C	1
Rademacher, BL	1
Janeba, N	1
Fazli, L	1
Lange, PH	1
Lieberman, S	1
Pinto, AC	1
Moreira, JN	1
Simões, S	1
Zhao, H	1
Halicka, HD	1
Traganos, F	1
Jorgensen, E	1
Darzynkiewicz, Z	2
Loebinger, MR	1
Sage, EK	1
Davies, D	1
Janes, SM	1
Fleming, MT	1
Sonpavde, G	1
Kolodziej, M	1
Awasthi, S	1
Hutson, TE	1
Martincic, D	1
Rastogi, A	1
Rousey, SR	1
Weinstein, RE	1
Galsky, MD	1
Berry, WR	2
Wang, Y	1
Boehm, KA	1
Asmar, L	2
Rauch, MA	1
Berry, W	1
Dakhil, S	1
Modiano, M	1
Gregurich, M	1
Rago, RP	1
Einstein, A	1
Lush, R	1
Ko, YJ	1
Henner, WD	1
Bubley, G	1
Merica, EA	1
Garg, V	1
Ette, E	1
Harding, MW	1
Dalton, WS	1
Petit, T	1
Borel, C	1
Theobald, S	1
Serin, D	1
Rodier, JF	1
Prevot, G	1
Brettes, JP	1
Klein, T	1
Almond, BA	1
Hadba, AR	1
Freeman, ST	1
Cuevas, BJ	1
York, AM	1
Detrisac, CJ	1
Goldberg, EP	1
Clements, DN	1
Hogan, AM	1
Cave, TA	1
Schmidt, U	1
Bilkenroth, U	1
Linné, C	1
Fuessel, S	1
Kraemer, K	1
Froehner, M	1
Wirth, MP	1
Meye, A	1
Kluza, J	1
Marchetti, P	1
Gallego, MA	1
Lancel, S	1
Fournier, C	1
Loyens, A	1
Beauvillain, JC	1
Bailly, C	1
Horti, J	1
Pluzanska, A	1
Chi, KN	1
Oudard, S	2
Théodore, C	1
James, ND	1
Turesson, I	1
Rosenthal, MA	1
Petrylak, DP	1
Tangen, CM	2
Hussain, MH	3
Lara, PN	1
Jones, JA	1
Taplin, ME	1
Burch, PA	1
Berry, D	1
Moinpour, C	1
Kohli, M	1
Benson, MC	1
Small, EJ	2
Raghavan, D	3
Crawford, ED	4
Dagher, R	1
Li, N	1
Abraham, S	1
Rahman, A	1
Sridhara, R	1
Pazdur, R	1
Banu, E	1
Beuzeboc, P	1
Voog, E	1
Dourthe, LM	1
Hardy-Bessard, AC	1
Linassier, C	1
Scotté, F	1
Banu, A	1
Coscas, Y	1
Guinet, F	1
Poupon, MF	1
Andrieu, JM	1
Joshua, AM	1
Nordman, I	1
Venkataswaran, R	1
Clarke, S	1
Stockler, MR	2
Boyer, MJ	1
Brandes, LJ	1
Klapp, K	1
Snyder, T	1
Styles, E	1
Tsao-Wei, D	1
Lieskovsky, G	1
Ramsey, EW	1
Protheroe, A	1
Sleijfer, S	1
Stoter, G	1
Cabrespine, A	1
Guy, L	1
Gachon, F	1
Curé, H	1
Chollet, P	1
Bay, JO	1
Mandecki, W	1
Ardelt, B	1
Coradetti, T	1
Davidowitz, H	1
AFlint, JA	1
Huang, Z	1
MKopacka, WM	1
Lin, X	1
Wang, Z	1
Rosenberg, JE	1
Weinberg, VK	1
Michaelson, D	1
Wilding, G	1
Gross, M	1
Hutcheon, D	1
Armstrong, AJ	1
Garrett-Mayer, E	1
Ou Yang, YC	1
Carducci, MA	1
Tannock, I	1
Eisenberger, M	1
Micha, JP	1
Goldstein, BH	1
Zusman, D	1
Rettenmaier, MA	1
Epstein, HD	1
Brown, JV	1
Zhang, HL	1
Yao, XD	1
Dai, B	1
Zhang, SL	1
Shen, YJ	1
Zhu, Y	1
Collette, L	1
Buyse, M	1
Burzykowski, T	1
Flaig, TW	1
Stadler, WM	1
Glodé, LM	1
Thuret, R	1
Massard, C	1
Gross-Goupil, M	1
Escudier, B	1
Di Palma, M	1
Bossi, A	1
de Crevoisier, R	1
Chauchereau, A	1
Fizazi, K	1
Valdivieso, M	1
Umsawasdi, T	1
Spitzer, G	1
Chiuten, DF	1
Booser, DJ	1
Dhingra, HM	1
Bodey, GP	1
Joss, RA	1
Cavalli, F	1
Goldhirsch, A	1
Mermillod, B	1
Brunner, KW	1
Osborne, CK	3
Drelichman, A	1
Von Hoff, DD	5
Alberts, DS	1
Peng, YM	1
Leigh, S	1
Davis, TP	1
Woodward, DL	1
Taylor, SA	2
Baker, LH	1
Balcerzak, SP	1
Cowan, JD	2
McDonald, B	1
Talley, RW	2
McCracken, JD	2
Chen, T	1
Bonnem, EM	1
Mitchell, EP	1
Woolley, PV	1
Smith, FP	1
Neefe, J	1
Smith, L	1
Schein, PS	1
Schabel, FM	1
Skipper, HE	1
Trader, MW	1
Brockman, RW	1
Laster, WR	1
Corbett, TH	1
Griswold, DP	1
Bufill, JA	1
Grace, WR	1
Neff, R	1
Frasci, G	1
Comella, G	1
Comella, P	1
Salzano, F	1
Cremone, L	1
Della Volpe, N	1
Imbriani, A	1
Persico, G	1
Khalil, A	1
Ciobanu, N	1
Sparano, JA	1
Gucalp, R	1
Dutcher, JP	2
Wiernik, PH	1
Fox, ME	1
Smith, PJ	1
Kobayashi, J	1
Kubota, K	1
Ishikawa, H	1
Asaumi, S	1
Iwanami, K	1
Matsumoto, H	1
Kawashima, K	1
Yokoe, T	1
Iino, Y	1
Morishita, Y	1
Jolivet, J	1
Bélanger, K	1
Yelle, L	1
Guévin, R	1
Potvin, M	1
Wilson, J	1
Rudinskas, L	1
Latreille, J	1
Dionne, J	1
Gagné, L	1
Asbury, RF	1
Cnaan, A	1
Johnson, L	1
Harris, J	1
Zaentz, SD	1
Haller, DG	2
Swain, SM	1
Honig, SF	1
Kantoff, PW	1
Block, C	1
Letvak, L	1
George, M	2
Chen, JA	1
Feun, LG	1
Savaraj, N	1
Solomon, J	1
Liebmann, A	1
Hurley, J	1
Nardi, M	1
Della Giulia, M	1
Pollera, CF	1
Marolla, P	1
Ruggeri, EM	1
Iacovelli, A	1
Atlante, G	1
Calabresi, F	1
Osoba, D	2
Ernst, DS	2
Neville, AJ	2
Moore, MJ	3
Armitage, GR	1
Wilson, JJ	1
Venner, PM	1
Coppin, CM	1
Murphy, KC	1
Muchmore, JH	1
Preslan, JE	1
George, WJ	1
Berti, E	1
Carrara, M	1
Ragazzi, E	1
D'Ancona, S	1
Berti, T	1
Kornmann, M	1
Danenberg, KD	1
Arber, N	1
Beger, HG	1
Danenberg, PV	1
Korc, M	1
Petrylak, D	1
Fisher, E	1
Tangen, C	1
Crawford, D	1
Novik, Y	1
Ryan, LM	1
Asbury, R	1
Schutt, A	1
Dowling, AJ	1
Czaykowski, PM	1
Krahn, MD	1
Fedier, A	1
Schwarz, VA	1
Walt, H	1
Carpini, RD	1
Haller, U	1
Fink, D	1
Obasaju, C	1
Hudes, GR	1
Knox, JJ	1
Haas, NB	1
Bubalo, JS	1
Heicappell, R	1
Peters, WH	1
Roelofs, HM	1
Pestalozzi, B	1
Schwendener, R	1
Sauter, C	1
Mitchell, PL	1
Harvey, VJ	1
Blumenstein, BA	1
Weiss, GR	1
Bukowski, RM	2
Larrimer, NR	1
Ayash, L	1
Korbut, T	1
Herman, TS	1
Teicher, BA	1
Neidhart, J	1
McClure, S	1
Coltman, CA	1
Gumbart, C	1
Martino, S	1
Hutchins, LF	1
Stephens, RL	2
Vaughan, CB	1
Veenhof, KH	1
Forni, M	1
Tumolo, S	1
Rotmensz, N	1
Vermorken, JB	1
Fleming, T	1
Natale, RB	1
Guy, JT	1
Samlowski, WE	1
Costanzi, JH	1
Levi, JA	1
Gill, PG	1
Presgrave, P	1
Henderson, IC	2
Allegra, JC	1
Woodcock, T	2
Wolff, S	1
Bryan, S	1
Cartwright, K	1
Dukart, G	1
Henry, D	1
Runge, HM	1
Meerpohl, HG	1
Pfleiderer, A	1
Chlebowski, RT	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
An Multicenter, Randomized Study of Comparison of Docetaxel Plus Prednisone With Mitoxantrone Plus Prednisone in the Patients With Hormone-refractory (Androgen-independent) Metastatic Prostate Cancer[NCT00436839]	Phase 3	228 participants (Actual)	Interventional	2007-01-31	Completed
A Phase 2, Multicenter, Randomized Study of IMC-A12 or IMC-1121B Plus Mitoxantrone and Prednisone in Metastatic Androgen-Independent Prostate Cancer (AIPC) Following Disease Progression on Docetaxel-Based Chemotherapy[NCT00683475]	Phase 2	138 participants (Actual)	Interventional	2008-08-31	Completed
Phase II Study of DN-101 (High Dose Pulse Calcitriol), Mitoxantrone, Prednisone in Androgen-Independent Prostate Cancer (AIPC)[NCT00182741]	Phase 2	19 participants (Actual)	Interventional	2004-09-30	Completed
A Randomized Phase II Study of Mitoxantrone vs. Mitoxantrone With Cetuximab in Metastatic Androgen Independent Prostate Cancer (AIPC) Previously Treated With Docetaxel-based Chemotherapy[NCT00661492]	Phase 2	115 participants (Actual)	Interventional	2008-05-31	Completed
F-choline PET in Early Response Assessment for Castration Resistant Prostatic Cancer Treated by Abiraterone Acetate or Enzalutamide[NCT01981707]	Phase 2/Phase 3	12 participants (Actual)	Interventional	2013-12-31	Terminated (stopped due to enrollment default)
Prospective Pilot Clinical Trial of Ac225-PSMA Radioligand Therapy of Metastatic Castration-resistant Prostate Cancer[NCT04225910]	Early Phase 1	20 participants (Anticipated)	Interventional	2020-01-01	Not yet recruiting
A Randomised Phase II Study of Two Dose Schedules of PI-88 in Combination With Docetaxel in Patients With Androgen-independent Prostate Cancer[NCT00268593]	Phase 2	48 participants (Actual)	Interventional	2005-08-31	Completed
A Phase II Study of Docetaxel Plus Carboplatin in Chemonaive Hormone-Refractory Prostate Cancer (HRPC) Patients[NCT00675545]	Phase 2	2 participants (Actual)	Interventional	2007-05-31	Completed
Phase I Study of Docetaxel and Temsirolimus in Resistant Solid Malignancies[NCT00703625]	Phase 1	26 participants (Actual)	Interventional	2008-03-08	Completed
A Randomized Phase II Trial Comparing Biomarker Directed Therapy Versus Clinician's Choice of Enzalutamide or Docetaxel in Patients With Advanced Prostate Cancer Post Abiraterone[NCT04015622]	Phase 2	100 participants (Anticipated)	Interventional	2020-10-07	Recruiting
A Pilot Study of F-18 Sodium Fluoride PET/CT for Metastatic Burden Qualification in Prostate Cancer[NCT01240551]	Phase 2	60 participants (Actual)	Interventional	2010-11-30	Completed
A Phase I/II Study of Alisertib in Combination With Abiraterone and Prednisone for Patients With Castration-Resistant Prostate Cancer After Progression on Abiraterone[NCT01848067]	Phase 1/Phase 2	9 participants (Actual)	Interventional	2013-08-14	Completed
A Multi-center, Open-label, Single Arm Phase III Clinical Trial for the Diagnostic Efficacy Assessment and Safety Evaluation by [18F]Florastamin PET/CT Imaging Examination in Patients With Suspected Recurrent or Metastatic Prostate Cancer[NCT05936658]	Phase 3	89 participants (Anticipated)	Interventional	2023-05-08	Recruiting
A Prospective, Multicenter, Three-arm, Randomized, Controlled Study Comparing the Efficacy of Neoadjuvant Hormonal Therapy Combined With Systemic Chemotherapy (NCHT), Neoadjuvant Hormonal Therapy (NHT) and Radical Prostatectomy Only in Locally Advanced Pr[NCT04220398]		475 participants (Anticipated)	Interventional	2020-01-10	Not yet recruiting
A Phase II Study of Proton-Based Radiation Therapy With Elective Pelvic Nodal Irradiation, Concomitant Docetaxel, and Adjuvant Androgen Deprivation for High-Risk Prostate Adenocarcinoma[NCT01040624]		77 participants (Actual)	Interventional	2009-12-31	Completed
A Phase I Study of Entinostat in Combination With Enzalutamide for Treatment of Patients With Castration-Resistant Prostate Cancer[NCT03829930]	Phase 1	6 participants (Actual)	Interventional	2019-05-01	Terminated (stopped due to Sponsor discontinued the drug)
Cultured Circulating Tumor Cells - Development of a Novel Platform for Drug Discovery and in Vitro Chemosensitivity Testing in Prostate and Other Cancers[NCT02123862]		220 participants (Anticipated)	Observational	2014-04-30	Recruiting
An Open-label, Phase I/IIa Dose Escalation and Expansion Study to Determine the Safety and Clinical Activity of an Immune Priming Cell Therapy (INKmune) in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)[NCT06056791]	Phase 1/Phase 2	30 participants (Anticipated)	Interventional	2023-11-30	Not yet recruiting
"Randomized Phase II Clinical Study of Radiation Therapy, Hormone Therapy and Chemotherapy With Docetaxel Versus Radiation Therapy and Hormone Therapy in Patients With High-Risk Localized Prostate Cancer (Stage III and IV)"[NCT03432780]	Phase 2	134 participants (Actual)	Interventional	2008-12-18	Active, not recruiting
A Phase 1b Dose Escalation Trial of PSK®/Placebo With Docetaxel to Treat Metastatic Castration-resistant Prostate Cancer[NCT01685489]	Phase 1	0 participants (Actual)	Interventional	2013-05-31	Withdrawn (stopped due to funding sequestered)
Docetaxel and Estramustine Versus Mitoxantrone and Prednisone for Advanced, Hormone Refractory Prostate Cancer[NCT00004001]	Phase 3	770 participants (Actual)	Interventional	1999-10-31	Completed
A Phase I Trial of Fractionated Docetaxel and Radium 223 in Metastatic Castration-Resistant Prostate Cancer (CRPC)[NCT03737370]	Phase 1	25 participants (Anticipated)	Interventional	2018-01-30	Recruiting
A Phase I and Randomized Phase II Multicenter Study of Cabozantinib (XL184) Plus Docetaxel and Prednisone in Metastatic Castrate Resistant Prostate Cancer[NCT01683994]	Phase 1/Phase 2	49 participants (Actual)	Interventional	2012-09-07	Completed
Adjuvant Androgen Deprivation Versus Mitoxantrone Plus Prednisone Plus Androgen Deprivation in Selected High-Risk Prostate Cancer Patients Following Radical Prostatectomy[NCT00004124]	Phase 3	983 participants (Actual)	Interventional	1999-10-15	Completed
Phase II Multicenter Study Evaluating the Efficacy of Carboplatin-Etoposide Combination in Hormone-resistant Prostate Cancers With Neuroendocrine Differentiation.[NCT00973882]	Phase 2	60 participants (Actual)	Interventional	2005-04-30	Completed
A Phase II Study of Oral Calcitriol in Combination With Ketoconazole in Castration Resistant Prostate Cancer, Progressing Despite Primary ADT and Abiraterone[NCT03261336]	Phase 2	1 participants (Actual)	Interventional	2017-01-06	Terminated (stopped due to can not meet enrollment)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

"Defined as the median time from randomization to the earliest of:~Tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST);~Evidence of progression by bone scan, performed after completion of the first 3 cycles, demonstrating the appearance of >=2 new lesions;~New skeletal events (New pathologic bone fracture in the region of metastatic disease; New bone lesion requiring radiation or surgery; Spinal cord or nerve root compression)~Symptomatic progression (for participants without measurable disease);~Other clinical events attributable to prostate cancer that require major interventions; or~Death from any cause~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy." (NCT00683475)
Timeframe: Randomization to composite progressive disease, up to 23.4 months

Composite Progression-free Survival (cPFS) at 12-months

Intervention	months (Median)
IMC-A12 + Mitoxantrone + Prednisone	4.1
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone	6.7

"Data presented are the percentage of participants without disease progression at 12 months.~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy." (NCT00683475)
Timeframe: 12 months

Composite Progression-free Survival (cPFS) at 6-months

Intervention	percentage of participants (Number)
IMC-A12 + Mitoxantrone + Prednisone	12.4
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone	20.0

"Data presented are the percentage of participants without disease progression at 6 months.~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy." (NCT00683475)
Timeframe: 6 months

Composite Progression-free Survival (cPFS) at 9-months

Intervention	percentage of participants (Number)
IMC-A12 + Mitoxantrone + Prednisone	37.2
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone	59.2

"Data presented are the percentage of participants without disease progression at 9 months.~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy." (NCT00683475)
Timeframe: 9 months

Objective Response Rate (ORR)

Intervention	percentage of participants (Number)
IMC-A12 + Mitoxantrone + Prednisone	20.7
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone	35.9

"Objective response is Complete Response (CR) + Partial Response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is a disappearance of all target and non-target lesions; PR is at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions.~Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100." (NCT00683475)
Timeframe: Baseline to date of progressive disease or death up to 36.3 months

Overall Survival (OS)

Intervention	percentage of participants (Number)
IMC-A12 + Mitoxantrone + Prednisone	15.2
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone	31.6

Overall survival is defined as the time from randomization to the date of death due to any cause. Participants who were alive at the time of study completion were censored at the time the participant was last known to be alive. (NCT00683475)
Timeframe: First dose to death due to any cause up to 36.3 months

Prostate Specific Antigen (PSA) Response Rate

Intervention	months (Median)
IMC-A12 + Mitoxantrone + Prednisone	10.8
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone	13.0

PSA response rate is defined as the percentage of participants with a decrease in PSA >= 50 percent from baseline. (NCT00683475)
Timeframe: Baseline up to data cut-off date (up to 36.3 months)

Time to Radiographic Evidence of Disease Progression

Intervention	percentage of participants (Number)
IMC-A12 + Mitoxantrone + Prednisone	18.5
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone	21.4

"Time between date of randomization and earliest date of radiographic progression defined as either:~Tumor progression by RECIST;~Evidence of progression by bone scan;~New skeletal events (New pathologic bone fracture in the region of metastatic disease; New bone lesion requiring radiation or surgery; Spinal cord or nerve root compression).~Participants who were ongoing with no radiographic evidence of disease progression, who discontinued treatment for reasons other than progression,or died before progression were censored at date of last tumor or bone radiographic assessment. Participants who started a new anticancer treatment before progression were censored at date of last tumor or bone radiographic assessment before start of new anti-cancer therapy." (NCT00683475)
Timeframe: Randomization to date of radiographic progression, up to 36.3 months

Summary Listing of Participants Reporting Treatment-Emergent Adverse Events

Intervention	months (Median)
IMC-A12 + Mitoxantrone + Prednisone	7.5
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone	10.2

Data presented are the number of participants who experienced A12 or 1121B (ramucirumab) related treatment-emergent adverse events (TEAE), treatment related serious adverse events (SAE), or any Grade 3 or higher TEAE; any TEAE leading to discontinuation of A12 or 1121B (ramucirumab) treatment, and any TEAE leading to dose modification of A12 or 1121B (ramucirumab). A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Event section. (NCT00683475)
Timeframe: Randomization to 36.3 months

2-year Radiographically Evident Progression-free Survival (REPFS).

Intervention	participants (Number)
	A12/1121B Related TEAE	A12/1121B Related Serious TEAE	A12/1121B Related Grade >= 3 TEAE	TEAE Leading to Dose Modification of A12/1121B	TEAE Leading to Discontinuation of A12/1121B
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone	63	16	31	35	25
IMC-A12 + Mitoxantrone + Prednisone	64	22	35	35	18

"Radiographic progression:~1) For bone scan, 2 unequivocal new lesions confirmed by a subsequent bone scan with at least 1 more new lesion; 2) Skeletal related event (eg, fracture, need for radiation to bone for pain, spinal cord compression, need for surgery to bone to prevent or treat a pathologic fracture)." (NCT00661492)
Timeframe: 24 months.

Median Overall Survival (OS)

Intervention	Probability of REPFS at 2-year (Number)
Arm 1	0.73
Arm 2	0.80

OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date. (NCT00661492)
Timeframe: 30 months

Median Progression-free Survival (PFS)

Intervention	months (Median)
Arm 1	11.9
Arm 2	15.7

PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date. (NCT00661492)
Timeframe: 24 months

Median Time to Progression (TTP)

Intervention	months (Median)
Arm 1	4.2
Arm 2	5.5

TTP will be measured from the start of treatment date to the date the patient is first recorded as having disease progression (even in patients who discontinue study treatment early due to toxicity or death due to disease progression. (NCT00661492)
Timeframe: 24 months

Median Time to Prostate-specific Antigen (PSA) Progression

Intervention	Months (Median)
Arm 1	4.9
Arm 2	6.6

Defined as the time from initiation of therapy until the first 25% increase from baseline in non-responders or 50% increase from nadir in responders as defined above. A minimum increase in the PSA of 5 ng/mL will be required for progression. (NCT00661492)
Timeframe: 24 months

Objective Response Rate (ORR)

Intervention	Months (Median)
Arm 1	2.7
Arm 2	2.7

ORR = CR + PR Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. (NCT00661492)
Timeframe: 24 months

Prostate-specific Antigen (PSA) Doubling Time

Intervention	percentage of participants (Number)
Arm 1	2.2
Arm 2	3.8

PSA doubling time = [log (2)× t] ÷ [log (final PSA) - log (initial PSA)] (NCT00661492)
Timeframe: 24 months

Prostate-specific Antigen (PSA) Response Rate

Intervention	months (Median)
Arm 1	2.3
Arm 2	1.5

Defined as the fraction of patients with a ≥50% reduction in serum PSA confirmed by a second serum PSA at least 3 weeks later (NCT00661492)
Timeframe: 24 months

Number of Participants With Adverse Events

Intervention	percentage of participants (Number)
Arm 1	7.7
Arm 2	17.6

Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module. (NCT01240551)
Timeframe: date treatment consent signed to date off study, approximately 52.5 months

Number of Participants With Present or Not Present Bone Metastasis

Intervention	Participants (Count of Participants)
Mets Via NaF-18 PET/CT	1
No-Mets Via NaF-18 PET/CT	1

Present and not present bone metastasis was determined by sodium fluoride (NaF) PET (positron emission imaging)/CT (computed tomography) imaging. Present bone metastasis is defined as greater than normal bone uptake. Not present bone metastasis is defined as physiological bone uptake of F-18 NaF on PET/CT imaging (i.e. excluding traumatic and degenerative foci of increased F-18 NaF uptake. (NCT01240551)
Timeframe: Single imaging sessions will be acquired at baseline, between 4-6 months and between 10-12 months on emolument.

Number of Participants With a PSA Value Equal to or Greater Than 25%

Intervention	Participants (Count of Participants)
	Baseline: Metastasis Present	Baseline: Metastasis Not Present	4-6 months: Metastasis Present	4-6 months: Metastasis not Present	10-12 months: Metastasis Present	10-12 months: Metastasis Not Present
Mets Via NaF-18 PET/CT	30	0	29	0	26	7
No-Mets Via NaF-18 PET/CT	10	20	9	20	7	13

Compared between the two patient subsets using the nonparametric Mann-Whitney test. A comparison of CTC counts between baseline and at progression for those who have progressed will be carried out using either a paired t test or the nonparameteric Wilcoxon matched pairs test. (NCT01848067)
Timeframe: Baseline up to 3 months

Phase I: Frequency of Dose Limiting Toxicities of Alisertib, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.1

Acute Grade 3 or Higher Treatment-related Toxicity Rate.

Intervention	Participants (Count of Participants)
Treatment (Alisertib, Abiraterone Acetate, Prednisone)	3

Intervention	Participants (Count of Participants)
Treatment (Alisertib, Abiraterone Acetate, Prednisone)	2

Number of participants that experienced acute grade 3 or higher, treatment-related toxicity based on CTCAE version 3.0 criteria. (NCT01040624)
Timeframe: 6 months after the completion of radiation therapy

Maximum Tolerated Dose (MTD)

Intervention	participants (Number)
HR-A	1
HR-B	3

MTD is defined as the dose level at which no more than 1 of 6 patients experiences a dose limiting toxicity (DLT) at the level below that which had two instances of DLT. A DLT are defined as adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) occurring during the first two cycles of therapy and related to the study medications (attributions: possible, probable, and definite) while fulfilling one of the following criteria: Any Grade 3 or greater non-hematologic toxicity except asymptomatic grade 3 hypertension, hypomagnesemia, hyponatremia, hypophosphatemia, hypocalcemia, and asymptomatic grade 4 uric acid. A treatment delay of > 2 weeks due to an adverse event (delays due to dental procedures are not included). Grade 4 neutropenia (absolute neutrophil count <500/µL lasting > 5 days. Febrile neutropenia. Grade 3 thrombocytopenia lasting for 7 days or more or thrombocytopenia < 50K/µL requiring platelet transfusion for bleeding. (NCT01683994)
Timeframe: First two cycles of treatment (each cycle is 21 days), approximately 42 days.

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

Intervention	mg (Number)
Ph I Cabozantinib + Docetaxel + Prednisone	40

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in 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. (NCT01683994)
Timeframe: Adverse events were assessed from the date treatment consent signed to date off study, approximately 45 months and 14 days for Arm A; 43 months and 14 days for Arm B; 9 months and 11 days for DL1; 27 months and 1 day for DL2; & 11 months & 25 days for DL3

Progression Free Survival (PFS) of Cabozantinib + Docetaxel + Prednisone Compared to Docetaxel + Prednisone Alone

Intervention	Participants (Count of Participants)
Ph I Dose Level 1:Cabozantinib + Docetaxel + Prednisone	4
Ph I Dose Level 2:Cabozantinib + Docetaxel + Prednisone	8
Ph I Dose Level 3:Cabozantinib + Docetaxel + Prednisone	7
Ph II Arm A: Docetaxel + Prednisone	12
Ph II Arm B: Cabozantinib + Docetaxel + Prednisone	13

PFS is the time interval from start of treatment to documented evidence of disease progression or death. Disease progression was assessed by the Response Criteria in Solid Tumors (RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions as referenced by the smallest sum on study. Appearance of one or more new lesions on bone scan and/or two consecutive rising prostatic-specific antigen values above the baseline at a minimum of one week intervals. A normal PSA value is 4.0 ng/ml and lower. (NCT01683994)
Timeframe: From start date of treatment until the date of first documented progression, date of death from any cause and up to 40 months, whichever occurred first.

Number of Participants Achieving Prostatic-Specific Antigen (PSA) Decline of 30% or 50% From Baseline

Intervention	months (Median)
Ph I Dose Level 1:Cabozantinib + Docetaxel + Prednisone	8
Ph I Dose Level 2:Cabozantinib + Docetaxel + Prednisone	13
Ph I Dose Level 3:Cabozantinib + Docetaxel + Prednisone	6
Ph II Arm A: Docetaxel + Prednisone	10
Ph II Arm B: Cabozantinib + Docetaxel + Prednisone	6.5

PSA normal range is 4 ng/ml or lower. Participants with PSA decline of 30% or 50% is the measures for prostate cancer based on conventional reporting metrics. (NCT01683994)
Timeframe: up to 38 months

Number of Participants With a Dose Limiting Toxicities (DLTs)

Intervention	Participants (Count of Participants)
	Decline in PSA>30% from baseline	Decline in PSA>50% from baseline
Ph I Dose Level 1:Cabozantinib + Docetaxel + Prednisone	0	0
Ph I Dose Level 2:Cabozantinib + Docetaxel + Prednisone	5	5
Ph I Dose Level 3:Cabozantinib + Docetaxel + Prednisone	5	4
Ph II Arm A Docetaxel + Prednisone	5	3
Ph II Arm B: Cabozantinib + Docetaxel + Prednisone	10	9

A DLT are defined as adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) occurring during the first two cycles of therapy and related to the study medications (attributions: possible, probable, and definite) while fulfilling one of the following criteria: Any Grade 3 or greater non-hematologic toxicity except asymptomatic grade 3 hypertension, hypomagnesemia, hyponatremia, hypophosphatemia, hypocalcemia, and asymptomatic grade 4 uric acid. A treatment delay of > 2 weeks due to an adverse event (delays due to dental procedures are not included). Grade 4 neutropenia (absolute neutrophil count <500/µL lasting > 5 days. Febrile neutropenia. Grade 3 thrombocytopenia lasting for 7 days or more or thrombocytopenia < 50K/µL requiring platelet transfusion for bleeding. (NCT01683994)
Timeframe: First two cycles of treatment (each cycle is 21 days), approximately 42 days.

Disease Free Survival

Intervention	Participants (Count of Participants)
	Neutropenic fever	Palmar plantar erythroderma
Ph I Dose Level 1: Cabozantinib + Docetaxel + Prednisone	0	0
Ph I Dose Level 2: Cabozantinib + Docetaxel + Prednisone	0	0
Ph I Dose Level 3: Cabozantinib + Docetaxel + Prednisone	1	1

Measured from date of randomization to date of first observation of recurrence or death due to any cause. Patients without recurrence are censored at date of last contact. (NCT00004124)
Timeframe: at 10 Years

Overall Survival

Intervention	percentage of probability of survival (Number)
Arm I: Bicalutamide + Goserelin	72
Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin	72

Measured from date of randomization to date of death from any cause. Patient known to be alive are censored at date of last contact. (NCT00004124)
Timeframe: at 10 Years

Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients

Intervention	percentage of probability of survival (Number)
Arm I: Bicalutamide + Goserelin	87
Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin	86

Number of patients with adverse events that are related to study drug (NCT00004124)
Timeframe: Up to 22 months from registration

Toxicity and Tolerability of Experimental Arm

Intervention	Participants (Number)
	Abdominal pain/cramping	Abscess	Alkaline phosphatase increase	Allergic reaction	Allergic rhinitis	Alopecia	Anal incontinence	Anemia	Anorexia	Anxiety/agitation	Apnea	Arrhythmia, NOS	Arthralgia	Arthritis	Ataxia (incoordination)	Bilirubin increase	Blurred vision	Bone pain	Bruising	CPK increase	Cardiac ischemia/infarction	Cardiovascular-other	Cataract	Cerebrovascular ischemia	Chest pain,not cardio or pleur	Conduction abnormality/block	Confusion	Conjunctivitis	Constipation/bowel obstruction	Cough	Creatinine increase	Cushingoid appearance	Dehydration	Depression	Diarrhea without colostomy	Dizziness/light headedness	Dry eye	Dry skin	Dysmenorrhea	Dyspepsia/heartburn	Dyspnea	Dysuria	Ear-other	Edema	Endocrine-other	Epistaxis	Erectile impotence	Eryth/rash/eruption/desq, NOS	Esophagitis/dysphagia	Eye-other	Fatigue/malaise/lethargy	Febrile neutropenia	Feminization of male	Fever without neutropenia	Fever, NOS	Flatulence	Flu-like symptoms-other	Flushing	GGT increase	GI Mucositis, NOS	GI-other	GU-other	Gastritis
Arm I: Bicalutamide + Goserelin	19	0	11	1	2	91	2	52	7	52	1	0	43	17	1	5	3	19	1	0	1	0	5	1	11	1	6	0	57	10	7	0	0	80	55	33	1	11	0	7	21	14	0	40	3	0	181	0	2	1	258	0	1	0	1	2	2	5	1	0	12	9	2
Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin	41	1	11	5	16	131	2	141	41	62	1	1	64	17	1	20	6	34	14	2	1	5	6	0	19	0	14	4	117	34	17	8	6	85	75	71	5	28	1	44	49	11	2	56	2	2	146	2	13	6	357	2	0	9	6	3	6	4	0	10	20	9	0

Descriptive analysis of observed toxicity and patient reports of tolerating experimental treatment (NCT03261336)
Timeframe: 2 years

Article	Year
New agents in non-small cell lung cancer. Cancer treatment reviews, 1984, Volume: 11, Issue:3 Topics: Adenocarcinoma; Adult; Alkylating Agents; Animals; Anthraquinones; Antibiotics, Antineoplastic; Anti	1984
Intra-arterial chemotherapy for palliation of fungating breast cancer. A case report and review of the literature. American journal of clinical oncology, 1994, Volume: 17, Issue:2 Topics: Adenocarcinoma; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Cisplatin; Female;	1994
Paclitaxel and docetaxel in prostate cancer. Hematology/oncology clinics of North America, 2001, Volume: 15, Issue:3 Topics: Adenocarcinoma; Antineoplastic Agents, Phytogenic; Antineoplastic Combined Chemotherapy Protocols; A	2001
Treatment of hormone refractory prostate cancer. Seminars in urologic oncology, 2001, Volume: 19, Issue:3 Topics: Adenocarcinoma; Antineoplastic Agents, Hormonal; Antineoplastic Combined Chemotherapy Protocols; Est	2001
Can chemotherapy alter the course of prostate cancer? Seminars in urologic oncology, 2001, Volume: 19, Issue:3 Topics: Adenocarcinoma; Antineoplastic Combined Chemotherapy Protocols; Docetaxel; Estramustine; Humans; Mal	2001
Complications of chemotherapy for prostate cancer. Seminars in urologic oncology, 2001, Volume: 19, Issue:3 Topics: Adenocarcinoma; Alopecia; Antineoplastic Combined Chemotherapy Protocols; Bone Marrow; Docetaxel; Ga	2001
Controversies in chemotherapy of prostate cancer. Frontiers of radiation therapy and oncology, 2002, Volume: 36 Topics: Adenocarcinoma; Adrenal Cortex Hormones; Androgen Antagonists; Antigens, Neoplasm; Antineoplastic Ag	2002

Article	Year
6,9-Bis[(aminoalkyl)amino]benzo[g]isoquinoline-5,10-diones. A novel class of chromophore-modified antitumor anthracene-9,10-diones: synthesis and antitumor evaluations. Journal of medicinal chemistry, 1994, Mar-18, Volume: 37, Issue:6 Topics: Adenocarcinoma; Animals; Anthraquinones; Antineoplastic Agents; Colonic Neoplasms; Humans; Isoquinol	1994
Synthesis and antitumor evaluation of 2,5-disubstituted-indazolo[4, 3-gh]isoquinolin-6(2H)-ones (9-aza-anthrapyrazoles). Journal of medicinal chemistry, 1998, Dec-31, Volume: 41, Issue:27 Topics: Adenocarcinoma; Animals; Antineoplastic Agents; Colonic Neoplasms; Drug Resistance, Multiple; Drug R	1998
Structure-based identification of a NEDD8-activating enzyme inhibitor via drug repurposing. European journal of medicinal chemistry, 2018, Jan-01, Volume: 143 Topics: Adenocarcinoma; Apoptosis; Caco-2 Cells; Cell Line; Colorectal Neoplasms; Dose-Response Relationship	2018
Targeting Discoidin Domain Receptor 1 (DDR1) Signaling and Its Crosstalk with β International journal of molecular sciences, 2020, Jul-13, Volume: 21, Issue:14 Topics: Adenocarcinoma; ATP Binding Cassette Transporter, Subfamily G, Member 2; Biological Transport; Breas	2020
Identifying Severe Adverse Event Clusters Using the National Cancer Institute's Common Terminology Criteria for Adverse Events. Journal of oncology practice, 2016, Volume: 12, Issue:3 Topics: Adenocarcinoma; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Clinical Tr	2016
Interleukin-1 beta and tumor necrosis factor-alpha increase ABCG2 expression in MCF-7 breast carcinoma cell line and its mitoxantrone-resistant derivative, MCF-7/MX. Inflammation research : official journal of the European Histamine Research Society ... [et al.], 2009, Volume: 58, Issue:10 Topics: Adenocarcinoma; Antineoplastic Agents; ATP Binding Cassette Transporter, Subfamily G, Member 2; ATP-	2009
Transcriptional modulation of BCRP gene to reverse multidrug resistance by toremifene in breast adenocarcinoma cells. Breast cancer research and treatment, 2010, Volume: 123, Issue:3 Topics: Adenocarcinoma; ATP Binding Cassette Transporter, Subfamily G, Member 2; ATP-Binding Cassette Transp	2010
Liposomal imatinib-mitoxantrone combination: formulation development and therapeutic evaluation in an animal model of prostate cancer. The Prostate, 2011, Jan-01, Volume: 71, Issue:1 Topics: Adenocarcinoma; Animals; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Benz	2011
New biomarkers probing depth of cell senescence assessed by laser scanning cytometry. Cytometry. Part A : the journal of the International Society for Analytical Cytology, 2010, Volume: 77, Issue:11 Topics: Adenocarcinoma; Apoptosis; beta-Galactosidase; Biomarkers; Cell Count; Cell Line, Tumor; Cell Nucleu	2010
TRAIL-expressing mesenchymal stem cells kill the putative cancer stem cell population. British journal of cancer, 2010, Nov-23, Volume: 103, Issue:11 Topics: Adenocarcinoma; Adult; Apoptosis; Cell Line, Tumor; Coculture Techniques; Humans; Lung Neoplasms; Me	2010
Efficacy of mitoxantrone-loaded albumin microspheres for intratumoral chemotherapy of breast cancer. Journal of controlled release : official journal of the Controlled Release Society, 2003, Aug-28, Volume: 91, Issue:1-2 Topics: Adenocarcinoma; Albumins; Animals; Antineoplastic Agents; Body Weight; Female; Mammary Neoplasms, Ex	2003
Treatment of a well differentiated pulmonary adenocarcinoma in a cat by pneumonectomy and adjuvant mitoxantrone chemotherapy. Journal of feline medicine and surgery, 2004, Volume: 6, Issue:3 Topics: Adenocarcinoma; Animals; Antineoplastic Agents; Cat Diseases; Cats; Chemotherapy, Adjuvant; Diagnosi	2004
Quantification of disseminated tumor cells in the bloodstream of patients with hormone-refractory prostate carcinoma undergoing cytotoxic chemotherapy. International journal of oncology, 2004, Volume: 24, Issue:6 Topics: Adenocarcinoma; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Estramustin	2004
Mitochondrial proliferation during apoptosis induced by anticancer agents: effects of doxorubicin and mitoxantrone on cancer and cardiac cells. Oncogene, 2004, Sep-16, Volume: 23, Issue:42 Topics: Adenocarcinoma; Antineoplastic Agents; Apoptosis; Breast Neoplasms; Cell Line; Cell Line, Tumor; Dox	2004
Circulating chromogranin a and hormone refractory prostate cancer chemotherapy. The Journal of urology, 2006, Volume: 175, Issue:4 Topics: Adenocarcinoma; Aged; Androgen Antagonists; Antineoplastic Agents; Biomarkers, Tumor; Carboplatin; C	2006
Microtransponders, the miniature RFID electronic chips, as platforms for cell growth in cytotoxicity assays. Cytometry. Part A : the journal of the International Society for Analytical Cytology, 2006, Nov-01, Volume: 69, Issue:11 Topics: Adenocarcinoma; Antineoplastic Agents; Breast Neoplasms; Carcinoma, Transitional Cell; Cell Culture	2006
Malignant pericardial effusion secondary to ovarian adenocarcinoma: a case report. The Journal of reproductive medicine, 2007, Volume: 52, Issue:10 Topics: Adenocarcinoma; Antineoplastic Agents; Female; Heart Neoplasms; Humans; Middle Aged; Mitoxantrone; O	2007
Docetaxel plus prednisone versus mitoxantrone plus prednisone for metastatic hormone-refractory prostate cancer in Chinese patients: experience of a single center. Urologia internationalis, 2007, Volume: 79, Issue:4 Topics: Adenocarcinoma; Aged; Aged, 80 and over; Antineoplastic Agents, Hormonal; Antineoplastic Combined Ch	2007
Are prostate-specific antigen changes valid surrogates for survival in hormone-refractory prostate cancer? A meta-analysis is needed! Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2007, Dec-10, Volume: 25, Issue:35 Topics: Adenocarcinoma; Aged; Antineoplastic Combined Chemotherapy Protocols; Biomarkers, Tumor; Docetaxel;	2007
The postchemotherapy PSA surge syndrome. Annals of oncology : official journal of the European Society for Medical Oncology, 2008, Volume: 19, Issue:7 Topics: Adenocarcinoma; Adult; Aged; Aged, 80 and over; Androgen Antagonists; Antineoplastic Agents; Antineo	2008
Phase II clinical evaluation of dihydroxyanthracenedione in patients with advanced lung cancer. American journal of clinical oncology, 1984, Volume: 7, Issue:3 Topics: Adenocarcinoma; Adult; Aged; Anthraquinones; Antineoplastic Agents; Carcinoma, Small Cell; Carcinoma	1984
Mitoxantrone: modest activity in a phase II trial in advanced prostate cancer. Cancer treatment reports, 1983, Volume: 67, Issue:12 Topics: Adenocarcinoma; Aged; Anthraquinones; Drug Evaluation; Humans; Leukopenia; Male; Middle Aged; Mitoxa	1983
Disposition of mitoxantrone in patients. Cancer treatment reviews, 1983, Volume: 10 Suppl B Topics: Adenocarcinoma; Anthraquinones; Antineoplastic Agents; Carcinoma, Squamous Cell; Drug Evaluation; Fe	1983
Phase II trial of mitoxantrone in previously untreated patients with colorectal adenocarcinoma: A Southwest Oncology Group Study. Cancer treatment reports, 1982, Volume: 66, Issue:9 Topics: Adenocarcinoma; Adult; Aged; Anthraquinones; Antineoplastic Agents; Colonic Neoplasms; Drug Evaluati	1982
Phase II trial of mitoxantrone in advanced colorectal cancer. Cancer treatment reports, 1982, Volume: 66, Issue:11 Topics: Adenocarcinoma; Adult; Aged; Anthraquinones; Antineoplastic Agents; Colonic Neoplasms; Drug Evaluati	1982
Drug control of Ara-C-resistant tumor cells. Medical and pediatric oncology, 1982, Volume: 10 Suppl 1 Topics: 3-Deazauridine; Adenocarcinoma; Animals; Anthraquinones; Antimetabolites, Antineoplastic; Colonic Ne	1982
Subcellular localisation of the antitumour drug mitoxantrone and the induction of DNA damage in resistant and sensitive human colon carcinoma cells. Cancer chemotherapy and pharmacology, 1995, Volume: 35, Issue:5 Topics: Adenocarcinoma; Animals; Cell Nucleus; Colonic Neoplasms; Cross-Linking Reagents; Cytoplasm; DNA Dam	1995
[A case of recurrent breast cancer responding to combination therapy with mitoxantrone (MIT), 5'-deoxy-5-fluorouridine (5'-DFUR) and medroxyprogesterone acetate (MPA)]. Gan to kagaku ryoho. Cancer & chemotherapy, 1994, Volume: 21, Issue:14 Topics: Adenocarcinoma; Administration, Oral; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplas	1994
Mitoxantrone, 5-FU, and leucovorin in breast cancer. Medical and pediatric oncology, 1994, Volume: 22, Issue:6 Topics: Adenocarcinoma; Alopecia; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Drug Adm	1994
A comparison of the modulation of antiblastics cytotoxicity by verapamil and dipyridamole in a human colon carcinoma cell line. International journal of oncology, 1999, Volume: 15, Issue:1 Topics: Adenocarcinoma; Antibiotics, Antineoplastic; Antineoplastic Agents; ATP Binding Cassette Transporter	1999
Inhibition of cyclin D1 expression in human pancreatic cancer cells is associated with increased chemosensitivity and decreased expression of multiple chemoresistance genes. Cancer research, 1999, Jul-15, Volume: 59, Issue:14 Topics: Adenocarcinoma; Cyclin D1; Drug Resistance, Neoplasm; Enzyme Induction; Floxuridine; Fluorouracil; G	1999
Docetaxel (Taxotere) and estramustine versus mitoxantrone and prednisone for hormone-refractory prostate cancer: scientific basis and design of Southwest Oncology Group Study 9916. Seminars in oncology, 1999, Volume: 26, Issue:5 Suppl 17 Topics: Adenocarcinoma; Antineoplastic Combined Chemotherapy Protocols; Clinical Trials, Phase III as Topic;	1999
Prostate specific antigen response to mitoxantrone and prednisone in patients with refractory prostate cancer: prognostic factors and generalizability of a multicenter trial to clinical practice. The Journal of urology, 2000, Volume: 163, Issue:5 Topics: Adenocarcinoma; Aged; Antineoplastic Combined Chemotherapy Protocols; Clinical Trials, Phase III as	2000
Resistance to topoisomerase poisons due to loss of DNA mismatch repair. International journal of cancer, 2001, Aug-15, Volume: 93, Issue:4 Topics: Adaptor Proteins, Signal Transducing; Adenocarcinoma; Antibiotics, Antineoplastic; Antimetabolites,	2001
Biochemical characterization of resistance to mitoxantrone and adriamycin in Caco-2 human colon adenocarcinoma cells: a possible role for glutathione S-transferases. Cancer research, 1992, Apr-01, Volume: 52, Issue:7 Topics: Adenocarcinoma; ATP Binding Cassette Transporter, Subfamily B, Member 1; Cell Line; Cell Survival; C	1992
Phase I/II study of liposome-complexed mitoxantrone in patients with advanced breast cancer. Annals of oncology : official journal of the European Society for Medical Oncology, 1992, Volume: 3, Issue:6 Topics: Adenocarcinoma; Agranulocytosis; Breast Neoplasms; Dose-Response Relationship, Drug; Drug Carriers;	1992
Mitozantrone-induced onycholysis. European journal of cancer (Oxford, England : 1990), 1992, Volume: 28, Issue:1 Topics: Adenocarcinoma; Breast Neoplasms; Female; Humans; Male; Middle Aged; Mitoxantrone; Nail Diseases; Ov	1992
Combination of the minor groove-binder U73-975 or the intercalator mitoxantrone with antitumor alkylating agents in MCF-7 or MCF-7/CP cells. Cancer letters, 1991, Dec-09, Volume: 61, Issue:1 Topics: Adenocarcinoma; Alkylating Agents; Antineoplastic Combined Chemotherapy Protocols; Benzofurans; Brea	1991
Mitoxantrone in advanced and/or recurrent endometrial carcinoma. European journal of cancer (Oxford, England : 1990), 1990, Volume: 26, Issue:5 Topics: Adenocarcinoma; Aged; Drug Evaluation; Female; Humans; Middle Aged; Mitoxantrone; Uterine Neoplasms	1990
Mitoxantrone therapy of advanced adenocarcinoma of the endometrium. A phase II trial. Onkologie, 1989, Volume: 12, Issue:2 Topics: Adenocarcinoma; Aged; Drug Evaluation; Female; Follow-Up Studies; Humans; Middle Aged; Mitoxantrone;	1989
Application of a new radiometric system for identification of potentially useful drug combinations for treatment of human gastrointestinal adenocarcinoma. Oncology, 1989, Volume: 46, Issue:3 Topics: Adenocarcinoma; Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Cytarabine; Drug Screenin	1989
Histological findings in the rat prostate cancer model during treatment with a luteinizing hormone-releasing hormone agonist and novantrone. The Prostate, 1987, Volume: 10, Issue:4 Topics: Adenocarcinoma; Animals; Capsules; Gonadotropin-Releasing Hormone; Injections, Intramuscular; Inject	1987
[A study of antineoplastic activity of DHAQ on human adenocarcinoma cells of lung hepatoma and gastric cancer cells in vitro]. Hua xi yi ke da xue xue bao = Journal of West China University of Medical Sciences = Huaxi yike daxue xuebao, 1986, Volume: 17, Issue:4 Topics: Adenocarcinoma; Carcinoma, Hepatocellular; Cell Line; Humans; Liver Neoplasms; Lung Neoplasms; Mitot	1986
Phase II study of mitoxantrone in advanced or metastatic endometrial carcinoma. The Australian & New Zealand journal of obstetrics & gynaecology, 1987, Volume: 27, Issue:4 Topics: Adenocarcinoma; Aged; Drug Evaluation; Female; Humans; Middle Aged; Mitoxantrone; Neoplasm Recurrenc	1987
Combined mitoxantrone plus doxorubicin in the treatment of breast cancer. American journal of clinical oncology, 1987, Volume: 10, Issue:4 Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Blood Platelets; Breast	1987
Mitoxantrone in the treatment of advanced non-squamous carcinoma of the cervix (a phase II trial of the gynecologic oncology group). Investigational new drugs, 1987, Volume: 5, Issue:2 Topics: Adenocarcinoma; Adult; Aged; Aged, 80 and over; Carcinoma; Drug Evaluation; Female; Humans; Middle A	1987
Urachal carcinoma: a response to chemotherapy. British journal of urology, 1987, Volume: 60, Issue:4 Topics: Adenocarcinoma; Antineoplastic Combined Chemotherapy Protocols; Fluorouracil; Humans; Male; Middle A	1987
Mitoxantrone in adenocarcinoma of the endometrium: a Southwest Oncology Group Study. Cancer treatment reports, 1985, Volume: 69, Issue:11 Topics: Adenocarcinoma; Aged; Anthraquinones; Endometrium; Female; Humans; Middle Aged; Mitoxantrone; Uterin	1985

Intervention	Participants (Number)
	Abdominal pain/cramping	Abscess	Alkaline phosphatase increase	Allergic reaction	Allergic rhinitis	Alopecia	Anal incontinence	Anemia	Anorexia	Anxiety/agitation	Apnea	Arrhythmia, NOS	Arthralgia	Arthritis	Ataxia (incoordination)	Bilirubin increase	Blurred vision	Bone pain	Bruising	CPK increase	Cardiac ischemia/infarction	Cardiovascular-other	Cataract	Cerebrovascular ischemia	Chest pain,not cardio or pleur	Conduction abnormality/block	Confusion	Conjunctivitis	Constipation/bowel obstruction	Cough	Creatinine increase	Cushingoid appearance	Dehydration	Depression	Diarrhea without colostomy	Dizziness/light headedness	Dry eye	Dry skin	Dysmenorrhea	Dyspepsia/heartburn	Dyspnea	Dysuria	Ear-other	Edema	Endocrine-other	Epistaxis	Erectile impotence	Eryth/rash/eruption/desq, NOS	Esophagitis/dysphagia	Eye-other	Fatigue/malaise/lethargy	Febrile neutropenia	Feminization of male	Fever without neutropenia	Fever, NOS	Flatulence	Flu-like symptoms-other	Flushing	GGT increase	GI Mucositis, NOS	GI-other	GU-other	Gastritis	Gastritis/ulcer, NOS	Glaucoma	Gynecomastia	Headache	Hematologic-other	Hematuria	Hemolysis	Hemoptysis	Hemorrhage-other	Hiccoughs	Hot flashes	Hypercalcemia	Hypercholesterolemia	Hyperglycemia	Hyperkalemia	Hypermagnesemia	Hypernatremia	Hypertension	Hypertriglyceridemia	Hypoalbuminemia	Hypocalcemia	Hypoglycemia	Hypokalemia	Hypomagnesemia	Hyponatremia	Hypotension	Hypothyroidism	Hypoxia	Incontinence	Infection w/o 3-4 neutropenia	Infection with 3-4 neutropenia	Infection, unk ANC	Inner ear-hearing loss	Insomnia	Invol. movement/restlessness	Joint,muscle,bone-other	LVEF decrease/CHF	Leukopenia	Libido loss	Local injection site reaction	Lung-other	Lymphopenia	Male infertility	Melena/ GI bleeding	Memory loss	Metabolic-other	Middle ear-hearing loss/otitis	Mood/consciousness change, NOS	Mouth dryness	Muscle weakness (not neuro)	Myalgia	Myalgia/arthralgia, NOS	Myocarditis	Nail changes	Nausea	Neuro-other	Neuropathic pain	Neutropenia/granulocytopenia	PRBC transfusion	Pain-other	Palpitations	Pelvic pain	Pericar. effusion/pericarditis	Personality/behavioral change	Phlebitis	Pigmentation changes/yellowing	Pleural effusions	Pneumonitis/infiltrates	Proctitis	Proteinuria	Pruritus	RT-GI mucositis, NOS	RT-focal dermatitis, NOS	RT-late bladder morbidity	RT-late intestinal morbidity	RT-pain	Rash/desquamation	Rectal bleeding/hematochezia	Rectal/perirectal pain	Respiratory infect w/o neutrop	Respiratory infection, unk ANC	Rigors/chills	SGOT (AST) increase	SGPT (ALT) increase	Salivary change, NOS	Second primary	Seizures	Sensory neuropathy	Sexual/reproductive-other	Sinus bradycardia	Skin-other	Speech impairment	Stomatitis/pharyngitis	Supraventricular arrhythmia	Surgery-wound infection	Sweating	Syncope	Taste disturbance	Tearing	Thrombocytopenia	Thrombosis/embolism	Tremor	Troponin T (cTnT) increase	Urinary frequency/urgency	Urinary retention	Urinary tr infect w/ neutrop	Urinary tr infect w/o neutrop	Urinary tr infection, unk ANC	Urine color change	Urticaria	Ventricular arrhythmia	Vertigo	Vision,NOS	Voice change/stridor/larynx	Vomiting	Weakness (motor neuropathy)	Weight gain	Weight loss
Arm I: Bicalutamide + Goserelin	19	0	11	1	2	91	2	52	7	52	1	0	43	17	1	5	3	19	1	0	1	0	5	1	11	1	6	0	57	10	7	0	0	80	55	33	1	11	0	7	21	14	0	40	3	0	181	0	2	1	258	0	1	0	1	2	2	5	1	0	12	9	2	0	2	140	37	1	9	0	0	1	0	439	4	5	44	0	0	0	38	2	1	1	0	8	1	3	3	2	0	88	5	0	1	3	79	2	11	0	14	163	11	0	4	2	0	15	0	0	2	10	55	26	1	0	4	26	5	0	11	0	112	1	9	0	12	0	0	0	0	4	3	13	0	3	1	2	1	46	12	7	1	1	7	42	22	0	0	1	37	2	0	11	0	5	0	0	138	0	1	0	3	2	0	0	86	13	0	1	3	3	3	1	1	0	0	10	3	179	12
Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin	41	1	11	5	16	131	2	141	41	62	1	1	64	17	1	20	6	34	14	2	1	5	6	0	19	0	14	4	117	34	17	8	6	85	75	71	5	28	1	44	49	11	2	56	2	2	146	2	13	6	357	2	0	9	6	3	6	4	0	10	20	9	0	1	0	100	82	1	13	1	1	4	4	422	5	2	78	4	1	4	38	0	6	7	1	11	1	2	11	0	4	71	10	2	4	2	92	2	27	8	317	133	17	2	49	3	2	12	1	1	3	13	77	45	12	1	57	205	4	1	239	3	127	6	11	1	11	5	3	1	1	4	1	23	1	1	0	1	0	63	10	5	7	8	24	42	26	1	6	1	57	1	4	11	1	49	2	1	129	3	46	6	35	5	2	1	101	7	1	2	2	44	4	0	1	1	6	51	6	151	29

mitoxantrone and Adenocarcinoma

Research Excerpts

Research

Studies (97)

Authors

Clinical Trials (26)

Trial Overview

Trial Outcomes

Composite Progression-free Survival (cPFS)

Composite Progression-free Survival (cPFS) at 12-months

Composite Progression-free Survival (cPFS) at 6-months

Composite Progression-free Survival (cPFS) at 9-months

Objective Response Rate (ORR)

Overall Survival (OS)

Prostate Specific Antigen (PSA) Response Rate

Time to Radiographic Evidence of Disease Progression

Summary Listing of Participants Reporting Treatment-Emergent Adverse Events

2-year Radiographically Evident Progression-free Survival (REPFS).

Median Overall Survival (OS)

Median Progression-free Survival (PFS)

Median Time to Progression (TTP)

Median Time to Prostate-specific Antigen (PSA) Progression

Objective Response Rate (ORR)

Prostate-specific Antigen (PSA) Doubling Time

Prostate-specific Antigen (PSA) Response Rate

Number of Participants With Adverse Events

Number of Participants With Present or Not Present Bone Metastasis

Number of Participants With a PSA Value Equal to or Greater Than 25%

Phase I: Frequency of Dose Limiting Toxicities of Alisertib, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.1

Acute Grade 3 or Higher Treatment-related Toxicity Rate.

Maximum Tolerated Dose (MTD)

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

Progression Free Survival (PFS) of Cabozantinib + Docetaxel + Prednisone Compared to Docetaxel + Prednisone Alone

Number of Participants Achieving Prostatic-Specific Antigen (PSA) Decline of 30% or 50% From Baseline

Number of Participants With a Dose Limiting Toxicities (DLTs)

Disease Free Survival

Overall Survival

Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients

Toxicity and Tolerability of Experimental Arm

Reviews

Trials

Other Studies