Ecteinascidin 743 in Treating Patients With Previously Treated Metastatic Osteosarcoma

Phase 2

Completed

• Conditions: Sarcoma

• Registration Number: NCT00005625
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 1999-12
• Study First Submitted: 2000-05-02
• Primary Completion: 2003-09
• Study Completion: 2003-09
• Study First Submitted QC: 2004-04-16
• Study First Posted: 2004-04-19
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-18
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States