Spots Global Cancer Trial Database for Ecteinascidin 743 in Treating Adults With Advanced Solid Tumors
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Trial Identification
Brief Title: Ecteinascidin 743 in Treating Adults With Advanced Solid Tumors
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 ID: NCT00002904
Interventions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Centre Leon Berard, Lyon, , France
CHU de la Timone, Marseille, , France
CRLCC Nantes - Atlantique, Nantes-Saint Herblain, , France
Institut Curie - Section Medicale, Paris, , France
Centre Eugene Marquis, Rennes, , France
Centre Henri Becquerel, Rouen, , France
Institut Claudius Regaud, Toulouse, , France
Centre Alexis Vautrin, Vandoeuvre-les-Nancy, , France
Hopital Paul Brousse, Villejuif, , France
Institut Gustave Roussy, Villejuif, , France
Martin Luther Universitaet, Halle Saale, , Germany
Universitats-Krankenhaus Eppendorf, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Klinikum Nurnberg, Nuremberg (Nurnberg), , Germany
University of Ioannina, Ioannina, , Greece
Rambam Medical Center, Haifa, , Israel
Schneider Children's Medical Center of Israel, Petah-Tikva, , Israel
Centro di Riferimento Oncologico - Aviano, Aviano, , Italy
Istituto Europeo Di Oncologia, Milano, , Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori, Naples (Napoli), , Italy
San Raffaele Hospital, Rome, , Italy
Istituti Fisioterapici Ospitalieri - Roma, Rome, , Italy
Academisch Ziekenhuis der Vrije Universiteit, Amsterdam, , Netherlands
Antoni van Leeuwenhoekhuis, Amsterdam, , Netherlands
Academisch Ziekenhuis Groningen, Groningen, , Netherlands
St. Radboud University Hospital, Nijmegen, , Netherlands
Rotterdam Cancer Institute, Rotterdam, , Netherlands
Norwegian Radium Hospital, Oslo, , Norway
Instituto Portugues de Oncologia de Francisco Gentil, Lisbon, , Portugal
Hospital Universitario 12 de Octubre, Madrid, , Spain
University Hospital, Basel, , Switzerland
Ospedale San Giovanni, Bellinzona, , Switzerland
Inselspital, Bern, Bern, , Switzerland
Clinique De Genolier, Genolier, , Switzerland
Kantonsspital - Saint Gallen, Saint Gallen, , Switzerland
Royal Marsden NHS Trust, London, England, United Kingdom
Newcastle General Hospital, Newcastle Upon Tyne, England, United Kingdom
Western General Hospital, Edinburgh, Scotland, United Kingdom
Beatson Oncology Centre, Glasgow, Scotland, United Kingdom
Contact Details
Name: Chris Twelves, MD, BMedSci, FRCP
Affiliation: University of Glasgow
Role: STUDY_CHAIR
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