BMS-247550 in Treating Patients With Metastatic Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00033306|
Recruitment Status : Terminated
First Posted : August 6, 2003
Last Update Posted : August 5, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: ixabepilone Drug: Fluoropyrimidine Drug: Irinotecan||Phase 2|
- 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 (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||July 2005|
|Actual Study Completion Date :||July 2005|
|Experimental: BMS-247550||Drug: ixabepilone Drug: Fluoropyrimidine Drug: Irinotecan|
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00033306
|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|