Spots Global Cancer Trial Database for Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma

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Trial Identification

Brief Title: Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma

Official Title: Exatecan As Second-Line Treatment In Advanced Adult Soft Tissue Sarcoma: A Phase II - Study Of The EORTC Soft Tissue And Bone Sarcoma Group

Study ID: NCT00041236

Conditions

Sarcoma

Interventions

exatecan mesylate

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 exatecan mesylate in treating patients who have advanced soft tissue sarcoma.

Detailed Description: OBJECTIVES: * Determine the anticancer activity of exatecan mesylate, in terms of objective response and duration of response, in patients with advanced soft tissue sarcoma. * Determine the safety of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to histological diagnosis (leiomyosarcoma vs other histologies). Patients receive exatecan mesylate IV over 30 minutes daily on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression. After disease progression, patients are followed every 12 weeks for survival. PROJECTED ACCRUAL: A total of 32-50 patients (16-25 per stratum) will be accrued for this study.