Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022477
Status:
COMPLETED
Last Update Posted:
2013-09-05
First Post:
2001-08-10
Brief Title:
BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Phase II Study Of Epothilone B Analog BMS-247550 NSC 710428D In Patients With Advanced Colorectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-09
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 recurrent or metastatic colorectal cancer
PURPOSE Phase II trial to study the effectiveness of BMS-247550 in treating patients who have recurrent or metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Determine the objective response rate in patients with locally recurrent or metastatic colorectal cancer treated with BMS-247550
Determine the toxicity of this drug in these patients
Determine the duration of response median and overall survival and time to progression in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive BMS-247550 IV over 3 hours on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 weeks
PROJECTED ACCRUAL A total of 21-50 patients will be accrued for this study within 8-10 months
Determine the objective response rate in patients with locally recurrent or metastatic colorectal cancer treated with BMS-247550
Determine the toxicity of this drug in these patients
Determine the duration of response median and overall survival and time to progression in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive BMS-247550 IV over 3 hours on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 weeks
PROJECTED ACCRUAL A total of 21-50 patients will be accrued for this study within 8-10 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-3670 | None | None | None |
| UCCRC-11003B | None | None | None |