Sarcoma Clinical Trial
Official title:
Phase II Study of ET-743 Therapy in Metastatic Osteosarcoma
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 previously treated metastatic osteosarcoma.
OBJECTIVES: I. Determine the partial and complete response rate in patients with previously
treated metastatic osteosarcoma when treated with ecteinascidin 743. II. Further
characterize the toxicity profile and the pharmacokinetic-pharmacodynamic relationships of
this drug in this patient population.
OUTLINE: This is a multicenter study. Patients receive ecteinascidin 743 IV over 24 hours.
Treatment continues every 6 weeks in the absence of unacceptable toxicity or disease
progression for at least 2-6 courses. Patients with a complete response (CR) receive at
least 2 additional courses after documented CR. Patients are followed every 3 months until
disease progression. All patients are followed until death after disease progression.
PROJECTED ACCRUAL: A total of 25-33 patients will be accrued for this study.
;
Primary Purpose: Treatment
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