Phase II Study Of ET-743 In Patients With Unresectable Malignant Pleural Mesothelioma
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.
Interventional
Primary Purpose: Treatment
Lee M. Krug, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
MSKCC-01084
NCT00027508
July 2001
February 2002
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Brigham and Women's Hospital | Boston, Massachusetts 02115 |