Ecteinascidin 743 in Treating Patients With Advanced Soft Tissue Sarcoma
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.
|Brain and Central Nervous System Tumors Endometrial Cancer Gastrointestinal Stromal Tumor Ovarian Cancer Sarcoma Small Intestine Cancer||Drug: trabectedin||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study on ET-743 in Advanced Soft Tissue Sarcomas of the Adult|
|Primary Completion Date:||November 2000 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003939
|Study Chair:||Axel Le Cesne, MD||Gustave Roussy, Cancer Campus, Grand Paris|