Spots Global Cancer Trial Database for BMS-247550 in Treating Patients With Recurrent Metastatic Stomach Cancer That Has Been Previously Treated With Chemotherapy

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Trial Identification

Brief Title: BMS-247550 in Treating Patients With Recurrent Metastatic Stomach Cancer That Has Been Previously Treated With Chemotherapy

Official Title: A Phase II Study Of Epothilone Analog BMS-247550 In Patients With Metastatic Gastric Adenocarcinoma Previously Treated With A Fluoropyrimidine And/Or Platinum

Study ID: NCT00017056

Conditions

Esophageal Cancer

Gastric Cancer

Interventions

ixabepilone

Study Description

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.

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.