Ecteinascidin 743 in Treating Patients With Previously Treated 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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of ET-743 Therapy in Metastatic Osteosarcoma|
|Study Start Date:||December 1999|
|Primary Completion Date:||September 2003 (Final data collection date for primary outcome measure)|
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.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Richard Gorlick, MD||Memorial Sloan-Kettering Cancer Center|