Malignant Mesothelioma Clinical Trial
Official title:
Phase II Study Of ET-743 In Patients With Unresectable Malignant Pleural Mesothelioma
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.
;
Primary Purpose: Treatment
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