Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016965
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2001-06-06
Brief Title:
BMS-247550 in Treating Patients With Advanced Pancreatic Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Epothilone B Analogue BMS-247550 NSC 710428 Every 21 Days in Patients With Advanced Pancreas Cancer
Status:
COMPLETED
Status Verified Date:
2003-04
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 advanced pancreatic cancer
PURPOSE Phase II trial to study the effectiveness of BMS-247550 in treating patients who have advanced pancreatic cancer
Detailed Description:
OBJECTIVES
Determine the 6-month survival rate and time to treatment failure in patients with advanced pancreatic adenocarcinoma treated with BMS-247550
Determine the frequency and severity of toxic effects of this drug in these patients
Determine the complete and partial response in those patients with measurable disease treated with this drug
Determine the pharmacokinetic profile of this drug in these patients
OUTLINE This is a multicenter study
Patients receive BMS-247550 IV over 3 hours on day 1 Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression
Patients are followed every 6 months for 2 years and then annually until 3 years after registration
PROJECTED ACCRUAL A total of 25-55 patients will be accrued for this study
Determine the 6-month survival rate and time to treatment failure in patients with advanced pancreatic adenocarcinoma treated with BMS-247550
Determine the frequency and severity of toxic effects of this drug in these patients
Determine the complete and partial response in those patients with measurable disease treated with this drug
Determine the pharmacokinetic profile of this drug in these patients
OUTLINE This is a multicenter study
Patients receive BMS-247550 IV over 3 hours on day 1 Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression
Patients are followed every 6 months for 2 years and then annually until 3 years after registration
PROJECTED ACCRUAL A total of 25-55 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SWOG-S0107 | None | None | None |