BMS-247550 in Treating Patients With Metastatic Stomach Cancer Previously Treated With Chemotherapy
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 stomach cancer previously treated with chemotherapy.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of Epothilone Analog BMS-247550 in Patients With Metastatic Gastric Adenocarcinoma Previously Treated With a Taxane|
|Study Start Date:||February 2001|
|Study Completion Date:||January 2003|
|Primary Completion Date:||January 2003 (Final data collection date for primary outcome measure)|
- Determine the clinical activity of BMS-247550, in terms of response rate, in patients with previously treated metastatic gastric adenocarcinoma.
- Determine the safety of this drug in these patients.
- Assess the response duration, 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 2-18 courses in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses after confirmation of CR.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 21-58 patients will be accrued for this study within 1 year.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Manish A. Shah, MD||Memorial Sloan-Kettering Cancer Center|