BMS-247550 in Treating Patients With Metastatic Colorectal Cancer
- Conditions
- Colorectal Cancer
- Interventions
- Registration Number
- NCT00033306
- Lead Sponsor
- University of Alabama at Birmingham
- 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 metastatic colorectal cancer.
- Detailed Description
OBJECTIVES:
* Determine the clinical activity of BMS-247550, as measured by the tumor response rate, in patients with metastatic colorectal cancer previously treated with a fluoropyrimidine and irinotecan.
* Determine the safety of this drug in these patients.
* Determine the response duration, time to progression, and survival in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive BMS-247550 IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive up to 4 additional courses of treatment beyond CR.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 19-55 patients will be accrued for this study within 6 months.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BMS-247550 Fluoropyrimidine - BMS-247550 ixabepilone - BMS-247550 Irinotecan -
- Primary Outcome Measures
Name Time Method Determine the clinical activity of BMS-247550, as measured by the tumor response rate, in patients with metastatic colorectal cancer previously treated with a fluoropyrimidine and irinotecan. baseline to survival
- Secondary Outcome Measures
Name Time Method Determine the safety of this drug in these patients. baseline to survival Determine the response duration, time to progression, and survival in patients treated with this drug. baseline to survival
Trial Locations
- Locations (2)
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Georgia Cancer Specialists
🇺🇸Atlanta, Georgia, United States