Spots Global Cancer Trial Database for Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer
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Trial Identification
Brief Title: Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer
Official Title: PHASE II TRIAL WITH DOCETAXEL IN PATIENTS WITH RELAPSING GERM CELL CANCER
Study ID: NCT00002903
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 II trial to study the effectiveness of docetaxel in treating patients with recurrent or refractory germ cell cancer.
Detailed Description: OBJECTIVES: I. Determine whether partial or complete responses can be achieved with docetaxel (TXT) in patients with recurrent or refractory disseminated germ cell cancer previously treated with standard-dose chemotherapy. II. Assess the probability of actual response warranting further evaluation of the therapeutic effectiveness of TXT in the case that partial or complete tumor responses are achieved in this patient population. III. Characterize further the toxic effects of TXT in these patients. 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, 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, , 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, 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: Emma Geertruida Elisabeth De Vries, MD, PhD
Affiliation: University Medical Center Groningen
Role: STUDY_CHAIR
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