Prostate Cancer Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who
have prostate cancer that has not responded to hormone therapy.
OBJECTIVES:
- Determine the prostate-specific antigen response to BMS-247550 in patients with
hormone-refractory prostate cancer.
- Determine the overall survival and progression-free survival rate in patients treated
with this drug.
- Determine the objective response rate (confirmed and unconfirmed complete and partial
responses) in those patients with measurable disease treated with this drug.
- Evaluate the qualitative and quantitative toxic effects of this regimen in these
patients.
OUTLINE: This is a multicenter study.
Patients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days in the
absence of disease progression or unacceptable toxicity. Patients achieving a complete
response (CR) receive 2 additional courses beyond CR.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 25-45 patients will be accrued for this study within 5-9
months.
;
Masking: Open Label, Primary Purpose: Treatment
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