Multi-institutional randomized phase II trial of the epothilone B analog ixabepilone (BMS-247550) with or without estramustine phosphate in patients with progressive castrate metastatic prostate cancer

Journal of Clinical Oncology

Volumn 23, Issue 7, 2005, Pages 1439-1446

  Galsky, Matthew D ^a   Small, Eric J ^a   Oh, William K ^a   Chen, Isan ^a   Smith, David C ^a   Colevas, A Dimitrios ^a   Martone, Lou ^a   Curley, Tracy ^a   DeLaCruz, Anthony ^a   Scher, Howard I ^a   Kelly, W Kevin ^a  

^a Department of Obstetrics Gynecology

Author keywords

[No Author keywords available]

Indexed keywords

DEXAMETHASONE; DIPHENHYDRAMINE; EPOTHILONE B; ESTRAMUSTINE PHOSPHATE; IXABEPILONE; PROSTATE SPECIFIC ANTIGEN; RANITIDINE; WARFARIN; ALKYLATING AGENT; ANTINEOPLASTIC AGENT; ANTINEOPLASTIC HORMONE AGONISTS AND ANTAGONISTS; EPOTHILONE DERIVATIVE; ESTRAMUSTINE;

ADULT; AGED; ANTINEOPLASTIC ACTIVITY; ARTICLE; BONE METASTASIS; CASTRATED MALE; CLINICAL TRIAL; COMPUTER ASSISTED TOMOGRAPHY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DEMOGRAPHY; DIARRHEA; DISEASE COURSE; DRUG DOSE REDUCTION; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSESTHESIA; FATIGUE; FEBRILE NEUTROPENIA; FOLLOW UP; HEART INFARCTION; HUMAN; LUNG EMBOLISM; MAJOR CLINICAL STUDY; METASTASIS; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROPATHY; NEUTROPENIA; PARESTHESIA; PERIPHERAL NEUROPATHY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROPHYLAXIS; PROSTATE CANCER; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; THROMBOCYTOPENIA; THROMBOEMBOLISM; THROMBOSIS; TREATMENT RESPONSE; VOMITING; CASTRATION; CHEMICALLY INDUCED DISORDER; MALE; MIDDLE AGED; PROSTATE TUMOR;

AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC AGENTS, ALKYLATING; ANTINEOPLASTIC AGENTS, HORMONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CASTRATION; EPOTHILONES; ESTRAMUSTINE; FATIGUE; HUMANS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; NEUTROPENIA; PERIPHERAL NERVOUS SYSTEM DISEASES; PROSTATIC NEOPLASMS; THROMBOSIS;

EID: 20144377696     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2005.09.042     Document Type: Article

References (30)

1. Kantoff PW, Halabi S, Conaway M, et al: Hydrocortisone with or without mitoxantrone in men with hormone-refractory prostate cancer: Results of the Cancer and Leukemia Group B 9182 study. J Clin Oncol 17:2506-2513, 1999
2. Tannock IF, Osoba D, Stockler MR, et al: Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: A Canadian randomized trial with palliative end points. J Clin Oncol 14:1756-1764, 1996
3. Tannock IF, de Wit R, Berry WR, et al: Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 351:1502-1512, 2004
4. Petrylak DP, Tangen CM, Hussain MH, et al: Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 351:1513-1520, 2004
5. Mareel MM, Storme GA, Dragonetti CH, et al: Antiinvasive activity of estramustine on malignant MO4 mouse cells and on DU-145 human prostate carcinoma cells in vitro. Cancer Res 48:1842-1849, 1988
6. Kreis W, Budman DR, Calabro A: Unique synergism or antagonism of combinations of chemotherapeutic and hormonal agents in human prostate cancer cell lines. Br J Urol 79:196-202, 1997
7. Speicher LA, Barone L, Tew KD: Combined antimicrotubule activity of estramustine and taxol in human prostatic carcinoma cell lines. Cancer Res 52:4433-4440, 1992
8. Berry W, Grengurich M, Dakhil S, et al: Phase II randomized study of weekly paclitaxel (Taxol) with or without estramustine phosphate in patients with symptomatic, hormone-refractory, metastatic carcinoma of the prostate. Proc Am Soc Clin Oncol 20:175, 2001 (abstr 696)
9. Hudes G, Einhorn L, Ross E, et al: Vinblastine versus vinblastine plus oral estramustine phosphate for patients with hormone-refractory prostate cancer: A Hoosier Oncology Group and Fox Chase Network phase III trial. J Clin Oncol 17:3160-3166, 1999
10. Petrylak D, Tangen C, Hussain M, et al: SWOG 99-16: Randomized phase III trial of docetaxel/estramustine versus mitoxantrone/prednisone in men with androgen independent prostate cancer. Proc Am Soc Clin Oncol 23:2, 2004 (abstr 3)
11. Hofle G, Bedorf N, Steinmetz H, et al: Epothilone A and B- Novel 16-membered macrolides with cytotoxic activity: Isolation, crystal structure, and comformation in solution. Agnew Chem Int Ed Engl 35:1567-1569, 1996
12. Bollag DM, McQueney PA, Zhu J, et al: Epothilones, a new class of microtubule-stabilizing agents with a taxol-like mechanism of action. Cancer Res 55:2325-2333, 1995
13. Sepp-Lorenzino L, Balog A, Su DS, et al: The microtubule-stabilizing agents epothilones A and B and their desoxy-derivatives induce mitotic arrest and apoptosis in human prostate cancer cells: Prostate Cancer Prostatic Dis 2:41-52, 1999
14. Newman RA, Yang J, Raymond M, et al: Antitumor efficacy of 26-fluoroepothilone B against human prostate cancer xenografts. Cancer Chemother Pharmacol 48:319-326, 2001
15. Lee FY, Borzilleri R, Fairchild CR, et al: BMS-247550: A novel epothilone analog with a mode of action similar to paclitaxel but possessing superior antitumor efficacy. Clin Cancer Res 7:1429-1437, 2001
16. Smaletz O, Galsky M, Scher HI, et al: Pilot study of epothilone B analog (BMS-247550) and estramustine phosphate in patients with progressive metastatic prostate cancer following castration. Ann Oncol 14:1518-1524, 2003
17. Ellis RE: The distribution of active bone marrow in the adult. Phys Med Biol 5:255-258, 1961
18. Simon R: Optimal two-stage designs for phase II clinical trials. Control Clin Trials 10:1-10, 1989
19. Scher HI, Mazumdar M, Kelly WK: Clinical trials in relapsed prostate cancer: Defining the target. J Natl Cancer Inst 88:1623-1634, 1996
20. Bubley GJ, Carducci M, Dahut W, et al: Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: Recommendations from the Prostate-Specific Antigen Working Group. J Clin Oncol 17:3461-3467, 1999
21. Therasse P, Arbuck SG, Eisenhauer EA, et al: New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92:205-216, 2000
22. Delbado C, Lara PN, Vansteenkiste J, et al: Phase II study of the novel epothilone BMS-247550 in patients with recurrent or metastatic non-small cell lung cancer who have failed first-line platinum-based therapy. Proc Am Soc Clin Oncol 21:303a, 2002 (abstr 1211)
23. Burris H, Awada A, Jones S, et al: Phase I study of the novel epothilone BMS-247550 administered weekly in patients with advanced malignancies. Proc Am Soc Clin Oncol 21:104a, 2002 (abstr 412)
24. Abraham J, Agrawal M, Bakke S, et al: Phase I trial and pharmacokinetic study of BMS-247550, an epothilone B analog, administered intravenously on a daily schedule for five days. J Clin Oncol 21:1866-1873, 2003
25. Savarese DM, Halabi S, Hars V, et al: Phase II study of docetaxel, estramustine, and low-dose hydrocortisone in men with hormone-refractory prostate cancer: A final report of CALGB 9780-Cancer and Leukemia Group B. J Clin Oncol 19:2509-2516, 2001
26. Petrylak DP: Chemotherapy for androgen-independent prostate cancer. Semin Urol Oncol 20:31-35, 2002
27. Rosenberg JE, Galsky MD, Weinberg V, et al: Response to second-line taxane-based therapy after first-line epothilone B analogue BMS-247550 therapy in hormone refractory prostate cancer. Proc Am Soc Clin Oncol 23:396, 2004 (abstr 4564)
28. Vansteenkiste J, Breton JL, Sandler A, et al: A randomized phase II study of epothilone analog BMS-247550 in patients with non-small cell lung cancer who have failed first-line platinum-based chemotherapy. Proc Am Soc Clin Oncol 22:626, 2003 (abstr 2519)
29. Thomas E, Tabernero J, Fornier M, et al: A phase II study of the epothilone B analog BMS-247550 in patients with taxane-resistant metastatic breast cancer. Proc Am Soc Clin Oncol 22:8, 2003 (abstr 30)
30. Ioffe ML, White E, Nelson DA, et al: Epothilone induced cytotoxicity is dependent on p53 status in prostate cells. Prostate 61:243-247, 2004