BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
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.
|Study Design:||Masking: None (Open Label)
Primary Purpose: Treatment
|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|
|Study Start Date:||June 2001|
|Study Completion Date:||April 2006|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00016393
Show 28 Study Locations
|Study Chair:||Maha Hadi A. Hussain, MD||University of Michigan Cancer Center|
|OverallOfficial:||Primo N. Lara, MD||University of California, Davis|