Ecteinascidin 743 in Treating Adults With Advanced Solid Tumors
|ClinicalTrials.gov Identifier: NCT00002904|
Recruitment Status : Completed
First Posted : September 3, 2004
Last Update Posted : July 2, 2012
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating adults with advanced solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: trabectedin||Phase 1|
OBJECTIVES: I. Estimate the maximum tolerated dose (MTD) of ecteinascidin-743 (ET-743) when administered as a single intravenous infusion every 21 days in adults with solid tumors not amenable to standard therapy. II. Describe the qualitative and quantitative toxic effects of ET-743, and study the predictability, duration, intensity, onset, reversibility, and dose-relationship of these toxic effects in these patients. III. Propose a safe dose for a phase II study based on the MTD determined on this study. IV. Assess the pharmacokinetics of ET-743 at different dose levels. V. Document any antitumor effects of ET-743 in these patients.
OUTLINE: This is a multicenter study. All patients receive ET-743 IV over 3 hours every 21 days for 4 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ET-743 until the maximum tolerated dose is determined. Patients are followed at 1 month, then every 3 months until disease progression.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study over 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Official Title:||PHASE I CLINICAL AND PHARMACOKINETIC STUDY TO DETERMINE THE SAFETY OF ECTEINASCIDIN-743 (ET-743) ADMINISTERED AS A SINGLE INTRAVENOUS INFUSION OVER 60 MINUTES EVERY 21 DAYS IN PATIENTS WITH SOLID TUMORS|
|Study Start Date :||February 1996|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002904
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|Study Chair:||Chris Twelves, MD, BMedSci, FRCP||University of Glasgow|