Ecteinascidin 743 in Treating Adults With Advanced Solid Tumors

June 29, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Chris Twelves, MD, BMedSci, FRCP, University of Glasgow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1996

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

September 2, 2004

First Posted (Estimate)

September 3, 2004

Study Record Updates

Last Update Posted (Estimate)

July 2, 2012

Last Update Submitted That Met QC Criteria

June 29, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-16951

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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