Ecteinascidin 743 in Treating Patients With Previously Treated Metastatic Osteosarcoma
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|ClinicalTrials.gov Identifier: NCT00005625|
Recruitment Status : Completed
First Posted : April 19, 2004
Last Update Posted : June 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: trabectedin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Study of ET-743 Therapy in Metastatic Osteosarcoma|
|Study Start Date :||December 1999|
|Actual Primary Completion Date :||September 2003|
|Actual Study Completion Date :||September 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005625
|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|