Ecteinascidin 743 in Treating Adults With Advanced Solid Tumors

NCT00002904 | Completed Phase 1

• 1 other identifier: EORTC-16951
• Study Type: interventional
• Target: 40
• Locations: 14 countries
• Sites: 49

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

trabectedin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (49)

Ludwig Boltzmann - Institute for Applied Cancer Research

Vienna (Wien), A-1100, Austria

Location

Institut Jules Bordet

Brussels (Bruxelles), 1000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Herlev Hospital - University Hospital of Copenhagen

Herlev, DK-2730, Denmark

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre Georges-Francois Leclerc

Dijon, 21034, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

CHU de la Timone

Marseille, 13385, France

Location

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, 44805, France

Location

Institut Curie - Section Medicale

Paris, 75248, France

Location

Centre Eugene Marquis

Rennes, 35062, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Hopital Paul Brousse

Villejuif, 94804, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Martin Luther Universitaet

Halle, DOH-0-6112, Germany

Location

Universitats-Krankenhaus Eppendorf

Hamburg, D-20246, Germany

Location

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

Klinikum Nurnberg

Nuremberg (Nurnberg), D-90419, Germany

Location

University of Ioannina

Ioannina, 45110, Greece

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Schneider Children's Medical Center of Israel

Petah Tikva, 49202, Israel

Location

Centro di Riferimento Oncologico - Aviano

Aviano, 33081, Italy

Location

Istituto Europeo Di Oncologia

Milan, 20141, Italy

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Naples (Napoli), 80131, Italy

Location

San Raffaele Hospital

Rome, 00144, Italy

Location

Istituti Fisioterapici Ospitalieri - Roma

Rome, 00161, Italy

Location

Academisch Ziekenhuis der Vrije Universiteit

Amsterdam, 1007 MB, Netherlands

Location

Antoni van Leeuwenhoekhuis

Amsterdam, 1066 CX, Netherlands

Location

Academisch Ziekenhuis Groningen

Groningen, 9713 EZ, Netherlands

Location

St. Radboud University Hospital

Nijmegen, 6500 HB, Netherlands

Location

Rotterdam Cancer Institute

Rotterdam, 3075 EA, Netherlands

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

Instituto Portugues de Oncologia de Francisco Gentil

Lisbon, 1093, Portugal

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

University Hospital

Basel, CH-4031, Switzerland

Location

Ospedale San Giovanni

Bellinzona, CH-6500, Switzerland

Location

Inselspital, Bern

Bern, CH-3010, Switzerland

Location

Clinique De Genolier

Genolier, Ch-1272, Switzerland

Location

Kantonsspital - Saint Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Royal Marsden NHS Trust

London, England, SW3 6JJ, United Kingdom

Location

Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Western General Hospital

Edinburgh, Scotland, EH4 9NQ, United Kingdom

Location

Beatson Oncology Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

MeSH Terms

Interventions

Trabectedin

Intervention Hierarchy (Ancestors)

Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Chris Twelves, MD, BMedSci, FRCP

  University of Glasgow

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: September 3, 2004
• Study Start: February 1, 1996
• Last Updated: July 2, 2012

Record last verified: 2012-06

Locations

FR (14); IL (2); NO (1); GR (1); DK (2); AU (1); DE (4); BE (3); CH (5); GB (4); IT (5); PT (1); NL (5); ES (1)