BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
- Conditions
- Prostate Cancer
- Registration Number
- NCT00016393
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
🇺🇸Hines, Illinois, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita
🇺🇸Wichita, Kansas, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Scroll for more (18 remaining)USC/Norris Comprehensive Cancer Center and Hospital🇺🇸Los Angeles, California, United States