Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017056
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2001-06-06
Brief Title:
BMS-247550 in Treating Patients With Recurrent Metastatic Stomach Cancer That Has Been Previously Treated With Chemotherapy
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Study Of Epothilone Analog BMS-247550 In Patients With Metastatic Gastric Adenocarcinoma Previously Treated With A Fluoropyrimidine AndOr Platinum
Status:
COMPLETED
Status Verified Date:
2013-06
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 metastatic stomach cancer that has been previously treated with chemotherapy
PURPOSE Phase II trial to study the effectiveness of BMS-247550 in treating patients who have recurrent metastatic stomach cancer that has been previously treated with chemotherapy
Detailed Description:
OBJECTIVES I Determine the clinical activity of BMS-247550 in terms of response rate in patients with recurrent metastatic gastric cancer previously treated with a fluoropyrimidine or platinum regimen II Determine the safety of this drug in this patient population III Determine the duration of response time to progression and survival of patients treated with this drug
OUTLINE This is a multicenter study Patients receive BMS-247550 IV over 1 hour on day 1 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 after CR Patients are followed every 3 months
PROJECTED ACCRUAL A total of 21-58 patients will be accrued for this study within 12 months
OUTLINE This is a multicenter study Patients receive BMS-247550 IV over 1 hour on day 1 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 after CR Patients are followed every 3 months
PROJECTED ACCRUAL A total of 21-58 patients will be accrued for this study within 12 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-G01-1950 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068645 | REGISTRY | None | None |