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Ecteinascidin 743 in Treating Adults With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00002904
Recruitment Status : Completed
First Posted : September 3, 2004
Last Update Posted : July 2, 2012
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

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.


Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: trabectedin Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Trabectedin





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed solid tumor that is not amenable to standard therapy No evidence of brain involvement or leptomeningeal disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: ANC at least 2,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5 mg/dL Transaminases normal (no greater than 2.5 times normal if liver metastases) Alkaline phosphatase normal (no greater than 2.5 times normal if liver or bone metastases) No history of chronic liver disease, e.g., chronic active hepatitis, cirrhosis Renal: Creatinine no greater than 1.4 mg/dL Creatinine clearance at least 60 mL/min Other: No active bacterial infection (e.g., abscess) or with fistulae No grade 2 or worse neurotoxicity No concurrent medical condition that precludes treatment No history of alcoholism, drug addiction, or psychotic disorder Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Colony-stimulating factors allowed for specific indications At least 4 weeks since prior biologic therapy, immunotherapy, or growth factors Chemotherapy: No prior intensive chemotherapy with bone marrow or stem cell support At least 4 weeks since chemotherapy (6 weeks since nitrosoureas, mitomycin, or high-dose carboplatin) Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since radiotherapy Concomitant palliative local radiotherapy allowed for existing lesion Surgery: Recovered from prior surgery Other: No concurrent investigational drug Concurrent prophylactic antiemetics allowed after first therapy course


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002904


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Locations
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Austria
Ludwig Boltzmann - Institute for Applied Cancer Research
Vienna (Wien), Austria, A-1100
Belgium
Institut Jules Bordet
Brussels (Bruxelles), Belgium, 1000
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Herlev Hospital - University Hospital of Copenhagen
Herlev, Denmark, DK-2730
France
Institut Bergonie
Bordeaux, France, 33076
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Centre Georges-Francois Leclerc
Dijon, France, 21034
Centre Oscar Lambret
Lille, France, 59020
Centre Leon Berard
Lyon, France, 69373
CHU de la Timone
Marseille, France, 13385
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, France, 44805
Institut Curie - Section Medicale
Paris, France, 75248
Centre Eugene Marquis
Rennes, France, 35062
Centre Henri Becquerel
Rouen, France, 76038
Institut Claudius Regaud
Toulouse, France, 31052
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Hopital Paul Brousse
Villejuif, France, 94804
Institut Gustave Roussy
Villejuif, France, F-94805
Germany
Martin Luther Universitaet
Halle Saale, Germany, DOH-0-6112
Universitats-Krankenhaus Eppendorf
Hamburg, Germany, D-20246
Medizinische Hochschule Hannover
Hannover, Germany, D-30625
Klinikum Nurnberg
Nuremberg (Nurnberg), Germany, D-90419
Greece
University of Ioannina
Ioannina, Greece, 45110
Israel
Rambam Medical Center
Haifa, Israel, 31096
Schneider Children's Medical Center of Israel
Petah-Tikva, Israel, 49202
Italy
Centro di Riferimento Oncologico - Aviano
Aviano, Italy, 33081
Istituto Europeo Di Oncologia
Milano, Italy, 20141
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples (Napoli), Italy, 80131
San Raffaele Hospital
Rome, Italy, 00144
Istituti Fisioterapici Ospitalieri - Roma
Rome, Italy, 00161
Netherlands
Academisch Ziekenhuis der Vrije Universiteit
Amsterdam, Netherlands, 1007 MB
Antoni van Leeuwenhoekhuis
Amsterdam, Netherlands, 1066 CX
Academisch Ziekenhuis Groningen
Groningen, Netherlands, 9713 EZ
St. Radboud University Hospital
Nijmegen, Netherlands, 6500 HB
Rotterdam Cancer Institute
Rotterdam, Netherlands, 3075 EA
Norway
Norwegian Radium Hospital
Oslo, Norway, N-0310
Portugal
Instituto Portugues de Oncologia de Francisco Gentil
Lisbon, Portugal, 1093
Spain
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Switzerland
University Hospital
Basel, Switzerland, CH-4031
Ospedale San Giovanni
Bellinzona, Switzerland, CH-6500
Inselspital, Bern
Bern, Switzerland, CH-3010
Clinique De Genolier
Genolier, Switzerland, Ch-1272
Kantonsspital - Saint Gallen
Saint Gallen, Switzerland, CH-9007
United Kingdom
Royal Marsden NHS Trust
London, England, United Kingdom, SW3 6JJ
Newcastle General Hospital
Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 9NQ
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
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Study Chair: Chris Twelves, MD, BMedSci, FRCP University of Glasgow

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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00002904     History of Changes
Other Study ID Numbers: EORTC-16951
EORTC-16951
First Posted: September 3, 2004    Key Record Dates
Last Update Posted: July 2, 2012
Last Verified: June 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
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Trabectedin
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents