Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer
NCT ID: NCT00002903
Last Updated: 2012-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
1995-07-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients with recurrent or refractory germ cell cancer.
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Detailed Description
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OUTLINE: Patients receive intravenous docetaxel over 1 hour every 3 weeks until disease progression, unacceptable toxicity, or at least 3 courses beyond documentation of complete response. Patients may receive concurrent radiotherapy provided not all indicator lesions are included in irradiated field. Resection of residual mature teratoma is allowed no sooner than 8 weeks after therapy provided tumor markers are normalized for at least 4 weeks.
PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.
Conditions
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Study Design
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TREATMENT
Interventions
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docetaxel
Eligibility Criteria
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Inclusion Criteria
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior high dose chemotherapy with or without stem cell transplant At least 3 weeks since chemotherapy and past WBC and platelet nadirs Endocrine therapy: Not specified Radiotherapy: Not amenable to curative radiotherapy At least 3 weeks since radiotherapy and recovered Surgery: Not amenable to surgery
18 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Emma Geertruida Elisabeth De Vries, MD, PhD
Role: STUDY_CHAIR
University Medical Center Groningen
Locations
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Ludwig Boltzmann - Institute for Applied Cancer Research
Vienna, , Austria
Institut Jules Bordet
Brussels, , 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 de Lute Contre le Cancer,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
Vandœuvre-lès-Nancy, , France
Hopital Paul Brousse
Villejuif, , France
Institut Gustave Roussy
Villejuif, , France
Martin Luther Universitaet
Halle, , Germany
Universitats-Krankenhaus Eppendorf
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , 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
Milan, , Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, , Italy
San Raffaele Hospital
Rome, , Italy
Istituti Fisioterapici Ospitalieri - Roma
Rome, , Italy
Antoni van Leeuwenhoekhuis
Amsterdam, , Netherlands
Academisch Ziekenhuis der Vrije Universiteit
Amsterdam, , Netherlands
Academisch Ziekenhuis Groningen
Groningen, , Netherlands
University Medical Center Nijmegen
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
Sankt 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
Countries
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Other Identifiers
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EORTC-16945T
Identifier Type: -
Identifier Source: secondary_id
EORTC-16945T
Identifier Type: -
Identifier Source: org_study_id
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