Clinical Trial: Ecteinascidin 743 in Treating Patients With Malignant Mesothelioma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Phase II Study Of ET-743 In Patients With Unresectable Malignant Pleural Mesothelioma

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 malignant mesothelioma that cannot be removed by surgery.

Detailed Summary:

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.

Sponsor: PharmaMar

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: PharmaMar

Dates:
Date Received: December 7, 2001
Date Started: July 2001
Date Completion:
Last Updated: February 23, 2015
Last Verified: June 2013