Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
Study NCT ID:
NCT00033306
Status:
TERMINATED
Last Update Posted:
2013-08-05
First Post:
2002-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BMS-247550 in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
A Phase II Study Of Epothilone Analog BMS-247550 In Patients With Metastatic Colorectal Cancer Previously Treated With A Fluoropyrimidine And Irinotecan
Status:
TERMINATED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: