BMS-247550 in Treating Patients With Metastatic Colorectal Cancer
Recruitment status was Active, not recruiting
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study Of Epothilone Analog BMS-247550 In Patients With Metastatic Colorectal Cancer Previously Treated With A Fluoropyrimidine And Irinotecan|
|Study Start Date:||February 2002|
- 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.
|United States, Alabama|
|University of Alabama at Birmingham Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294-3300|
|United States, Georgia|
|Georgia Cancer Specialists|
|Atlanta, Georgia, United States, 30342|
|Study Chair:||Andres Forero-Torres, MD, CSU||University of Alabama at Birmingham|