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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Georgia Cancer Specialists
Atlanta, Georgia, United States
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.
Time frame: baseline to survival
Determine the safety of this drug in these patients.
Time frame: baseline to survival
Determine the response duration, time to progression, and survival in patients treated with this drug.
Time frame: baseline to survival
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