Ecteinascidin 743 in Treating Patients With Advanced Soft Tissue Sarcoma

Phase 2

Completed

• Conditions: Brain and Central Nervous System Tumors; Endometrial Cancer; Gastrointestinal Stromal Tumor; Ovarian Cancer; Sarcoma; Small Intestine Cancer

• Registration Number: NCT00003939
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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 ecteinascidin 743 in treating patients who have advanced soft tissue sarcoma.

Detailed Description

OBJECTIVES: I. Determine the therapeutic activity of ecteinascidin 743 in patients with advanced soft tissue sarcomas. II. Determine the duration of response in these patients. III. Determine the acute side effects in these patients.

OUTLINE: This is a multicenter study. Patients receive ecteinascidin 743 (ET-743) IV over 24 hours every 3 weeks. Treatment continues for at least 2-6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression and every 12 weeks after disease progression.

PROJECTED ACCRUAL: Approximately 28-44 patients will be accrued for this study.

Study Timeline

• Study First Submitted: 1999-11-01
• Primary Completion: 2000-11
• Study First Submitted QC: 2004-06-02
• Study First Posted: 2004-06-03
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-20
• Last Update Posted: 2012-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified