Spots Global Cancer Trial Database for BMS-247550 in Treating Patients With Advanced Soft Tissue Sarcoma

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Trial Identification

Brief Title: BMS-247550 in Treating Patients With Advanced Soft Tissue Sarcoma

Official Title: A Phase II Study of Epothilone B Analog (BMS-247550) in Advanced Soft Tissue Sarcomas

Study ID: NCT00022542

Conditions

Recurrent Adult Soft Tissue Sarcoma

Stage III Adult Soft Tissue Sarcoma

Stage IV Adult Soft Tissue Sarcoma

Interventions

ixabepilone

Study Description

Brief Summary: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have advanced soft tissue sarcoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Detailed Description: OBJECTIVES: I. Determine the confirmed response rate of patients with advanced soft tissue sarcoma treated with BMS-247550. II. Determine the overall survival and progression-free survival of patients treated with this drug. III. Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive BMS-247550 IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response receive 2 additional courses. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 14-29 patients will be accrued for this study within 8 months.