Ecteinascidin 743 in Treating Adults With Advanced Solid Tumors
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00002904
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (49)
Ludwig Boltzmann - Institute for Applied Cancer Research
🇦🇹Vienna (Wien), Austria
Institut Jules Bordet
🇧🇪Brussels (Bruxelles), Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Rigshospitalet
🇩🇰Copenhagen, Denmark
Herlev Hospital - University Hospital of Copenhagen
🇩🇰Herlev, Denmark
Institut Bergonie
🇫🇷Bordeaux, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Centre Georges-Francois Leclerc
🇫🇷Dijon, France
Centre Oscar Lambret
🇫🇷Lille, France
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