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Ecteinascidin 743 in Treating Patients With Malignant Mesothelioma

Phase 2
Terminated
Conditions
Malignant Mesothelioma
Registration Number
NCT00027508
Lead Sponsor
PharmaMar
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 Description

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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
Not specified
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
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (4)

Memorial Sloan-Kettering Cancer Center

🇺🇸

New York, New York, United States

Dana-Farber Cancer Institute

🇺🇸

Boston, Massachusetts, United States

Brigham and Women's Hospital

🇺🇸

Boston, Massachusetts, United States

Massachusetts General Hospital Cancer Center

🇺🇸

Boston, Massachusetts, United States

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