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 malignant mesothelioma that cannot be removed by surgery.
OBJECTIVES: I. Determine partial and complete response rates in patients with unresectable malignant mesothelioma treated with ecteinascidin 743. II. Determine the toxicity profile of this drug in these patients. III. Determine the pharmacokinetic/pharmacodynamic relationships of this drug in these patients. IV. Determine the duration of response, time to disease progression, 6-month progression-free survival, time to treatment failure, and overall survival of patients treated with this drug. V. Assess the quality of life of these patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive ecteinascidin 743 IV over 3 hours on day 1. Treatment repeats every 3 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR. Quality of life is assessed at baseline and at the beginning of each course of therapy. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 20-36 patients will be accrued for this study within 12-24 months.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
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