Phase II Study of ET-743 Given as a Three Hour Intravenous Infusion in Patients With Advanced and/or Metastatic Soft Tissue Sarcoma Previously Treated With Chemotherapy
OBJECTIVES: I. Determine the rate of clinical benefit, in terms of the incidence of
objective partial and complete response, stable disease, or minor response of more than 3
months duration, in patients with previously treated, unresectable advanced or metastatic
soft tissue sarcoma treated with ecteinascidin 743. II. Determine the progression-free
survival, overall survival, and response duration in patients treated with this drug. III.
Determine the toxicity profile of this drug in these patients. IV. Determine the
pharmacokinetic-pharmacodynamic relationship of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to number of prior
cytotoxic therapies for advanced disease (1-2 vs more than 2). Patients receive
ecteinascidin 743 IV over 3 hours on day 1. Treatment repeats every 3 weeks for at least 2
courses in the absence of disease progression or unacceptable toxicity. Patients are
followed every 3 months.
PROJECTED ACCRUAL: A total of 36-76 patients (18-38 per stratum) will be accrued for this
study within 13 months.
Primary Purpose: Treatment
Robert Maki, MD, PhD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|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|