Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033306
Status:
TERMINATED
Last Update Posted:
2013-08-05
First Post:
2002-04-09
Brief Title:
BMS-247550 in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G02-2051 | None | None | None |
| UAB-0145 | None | None | None |
| BMS-CA163-012 | None | None | None |
| UAB-F011029021 | None | None | None |