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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 unresectable advanced or metastatic soft tissue sarcoma.
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
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:56:53-0400
A Study to Provide Access to Trabectedin in Participants With Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Persistent or Recurrent Disease and Who Are Not Expected to Benefit From Currently Available Standard of Care Treatment
The purpose of this study is to facilitate access to trabectedin for eligible previously treated patients with soft tissue sarcoma (STS), who cannot be expected to benefit from currently a...
The purpose of the study is to determine the effects of trabectedin on the heart's electrical cycle as measured by electrocardiograms (ECGs) in patients with advanced cancer. The study wil...
Two arm, randomized, open-label study, to determine the best time to secondary resistance between responding patients who discontinue treatment and resumed Trabectedin at the time of progr...
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An experimental sarcoma of mice.
An experimental sarcoma of mice.
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Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...