SWOG clinical trial number
S0111

A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) (IND 59699) Administered Every 21 Days in Patients with Hormone Refractory Prostate Cancer

Closed
Phase
Accrual
100%
Published
Abbreviated Title
Advanced Prostate
Activated
06/15/2001
Closed
11/15/2003
Participants
NCORP, Members, UCOP, Medical Oncologists, Surgeons, Pathologists

Research committees

Genitourinary Cancer

Treatment

BMS-247550

Eligibility Criteria Expand/Collapse

Pt must have histologic adenocarcinoma of the prostatewhich is measurable or evaluable Stage D1 or D2. Pts must have metastatic PCa deemed unresponsive or refractory to hormone therapy by criteria in Section 5.2 of the protocol. PSA >/= 5 ng/ml w/in 14 days prior to registration. Mx disease w/in 28 days; non-mx disease w/in 42 days. Pt must have baseline serum sample and agree to have submitted per Section 15.2. CT abd/pelvis w/in 28 days, bone scan w/in 42. Castrated & willing to continue/restart LHRH. At least 28 days out from flutamide or ketoconazole, 42 for bicalutamide or nilutamide. Prior RT >/=28 days prior to reg and to < 30% of bone marrow okay. No prior strontium or samarium. No prior chemo. One prior biologic. PS 0-2. AGC >/= 1500, PLT >/= 100,000, bili </= IULN, SGOT/SGPT </= 2.5 x IULN, creat </= 2.0 or CalcCrCl >/= 40 w/in 7 days. No unconventional therapy (St. John's Wort, PC-SPES). Not planning to begin bisphosphonates. No hx of brain mets.

Publication Information Expand/Collapse

2009

Cooperative group trials - Southwest Oncology Group (SWOG) innovations in advanced prostate cancer [PMID21085622; PMC2981166]

TB Dorff;C Tangen;ED Crawford;DP Petrylak;CS Higano;D Raghavan;DI Quinn;NJ Vogelzang;IM Thompson;MHA Hussain Therapeutic Advances in Medical Oncology 1(2):69-77;

2005

Ixabepilone (epothilone b analogue BMS-247550) is active in chemotherapy-naive patients with hormone-refractory prostate cancer: a Southwest Oncology Group trial S0111

M Hussain;CM Tangen;PN Lara;UN Vaishampayan;DP Petrylak;AD Colevas;WA Sakr;ED Crawford Journal of Clinical Oncology 23(34):8724-8729

2004

Epothilone B (Epo-B) analogue BMS-247550 (NSC# 710428) administered every 21 days in patients (pts) with hormone refractory prostate cancer (HRPC). a Southwest Oncology Group study (S0111)

M Hussain;J Faulkner;U Vaishampayan;P Lara;D Petrylak;D Colevas;W Sakr;ED Crawford Proc of the American Society of Clinical Oncology 23:383 (#4510)

Other Clinical Trials

SWOG Clinical Trial Number
S2312
SWOG Clinical Trial Number
S2210

S2210, "Targeted Neoadjuvant Treatment for Patients with Localized Prostate Cancer and Germline DNA Repair Deficiency"

Research Committee(s)
Genitourinary Cancer
Activated
08/14/2023
Accrual
7%
Open
Phase
SWOG Clinical Trial Number
S2200