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)
Centre Oscar Lambret
🇫🇷Lille, France
Martin Luther Universitaet
🇩🇪Halle Saale, Germany
Universitats-Krankenhaus Eppendorf
🇩🇪Hamburg, Germany
Rambam Medical Center
🇮🇱Haifa, Israel
Academisch Ziekenhuis der Vrije Universiteit
🇳🇱Amsterdam, Netherlands
Antoni van Leeuwenhoekhuis
🇳🇱Amsterdam, Netherlands
St. Radboud University Hospital
🇳🇱Nijmegen, Netherlands
Instituto Portugues de Oncologia de Francisco Gentil
🇵🇹Lisbon, Portugal
University Hospital
🇨ðŸ‡Basel, Switzerland
Ospedale San Giovanni
🇨ðŸ‡Bellinzona, Switzerland
Royal Marsden NHS Trust
🇬🇧London, England, United Kingdom
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Kantonsspital - Saint Gallen
🇨ðŸ‡Saint Gallen, Switzerland
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Centre Eugene Marquis
🇫🇷Rennes, France
Hopital Paul Brousse
🇫🇷Villejuif, France
Klinikum Nurnberg
🇩🇪Nuremberg (Nurnberg), Germany
Schneider Children's Medical Center of Israel
🇮🇱Petah-Tikva, Israel
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
CHU de la Timone
🇫🇷Marseille, France
CRLCC Nantes - Atlantique
🇫🇷Nantes-Saint Herblain, France
Institut Gustave Roussy
🇫🇷Villejuif, France
University of Ioannina
🇬🇷Ioannina, Greece
Centro di Riferimento Oncologico - Aviano
🇮🇹Aviano, Italy
Herlev Hospital - University Hospital of Copenhagen
🇩🇰Herlev, Denmark
Institut Curie - Section Medicale
🇫🇷Paris, France
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Istituti Fisioterapici Ospitalieri - Roma
🇮🇹Rome, Italy
Norwegian Radium Hospital
🇳🇴Oslo, Norway
San Raffaele Hospital
🇮🇹Rome, Italy
Rotterdam Cancer Institute
🇳🇱Rotterdam, Netherlands
Rigshospitalet
🇩🇰Copenhagen, Denmark
Ludwig Boltzmann - Institute for Applied Cancer Research
🇦🇹Vienna (Wien), Austria
Institut Jules Bordet
🇧🇪Brussels (Bruxelles), Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Institut Bergonie
🇫🇷Bordeaux, France
Centre Leon Berard
🇫🇷Lyon, France
Centre Georges-Francois Leclerc
🇫🇷Dijon, France
Istituto Nazionale per lo Studio e la Cura dei Tumori
🇮🇹Naples (Napoli), Italy
Centre Alexis Vautrin
🇫🇷Vandoeuvre-les-Nancy, France
Centre Henri Becquerel
🇫🇷Rouen, France
Istituto Europeo Di Oncologia
🇮🇹Milano, Italy
Institut Claudius Regaud
🇫🇷Toulouse, France
Academisch Ziekenhuis Groningen
🇳🇱Groningen, Netherlands
Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Inselspital, Bern
🇨ðŸ‡Bern, Switzerland
Clinique De Genolier
🇨ðŸ‡Genolier, Switzerland
Newcastle General Hospital
🇬🇧Newcastle Upon Tyne, England, United Kingdom
Beatson Oncology Centre
🇬🇧Glasgow, Scotland, United Kingdom