Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer
- Conditions
- Extragonadal Germ Cell TumorOvarian CancerTesticular Germ Cell Tumor
- Registration Number
- NCT00002903
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (49)
Herlev Hospital - University Hospital of Copenhagen
🇩🇰Herlev, Denmark
Istituto Europeo Di Oncologia
🇮🇹Milano, Italy
Rambam Medical Center
🇮🇱Haifa, Israel
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Centro di Riferimento Oncologico - Aviano
🇮🇹Aviano, Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
🇮🇹Naples, Italy
San Raffaele Hospital
🇮🇹Rome, Italy
Antoni van Leeuwenhoekhuis
🇳🇱Amsterdam, Netherlands
Rotterdam Cancer Institute
🇳🇱Rotterdam, Netherlands
Norwegian Radium Hospital
🇳🇴Oslo, Norway
University Hospital
🇨ðŸ‡Basel, Switzerland
Inselspital, Bern
🇨ðŸ‡Bern, Switzerland
Royal Marsden NHS Trust
🇬🇧London, England, United Kingdom
Centre Eugene Marquis
🇫🇷Rennes, France
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Ludwig Boltzmann - Institute for Applied Cancer Research
🇦🇹Vienna, Austria
Institut Jules Bordet
🇧🇪Brussels, Belgium
Centre Alexis Vautrin
🇫🇷Vandoeuvre-les-Nancy, France
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Rigshospitalet
🇩🇰Copenhagen, Denmark
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Centre Oscar Lambret
🇫🇷Lille, France
Institut Bergonie
🇫🇷Bordeaux, France
Institut Curie - Section Medicale
🇫🇷Paris, France
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
🇫🇷Dijon, France
Centre Leon Berard
🇫🇷Lyon, France
CHU de la Timone
🇫🇷Marseille, France
Centre Henri Becquerel
🇫🇷Rouen, France
CRLCC Nantes - Atlantique
🇫🇷Nantes-Saint Herblain, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Hopital Paul Brousse
🇫🇷Villejuif, France
Martin Luther Universitaet
🇩🇪Halle Saale, Germany
Universitats-Krankenhaus Eppendorf
🇩🇪Hamburg, Germany
Klinikum Nurnberg
🇩🇪Nuremberg (Nurnberg), Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Clinique De Genolier
🇨ðŸ‡Genolier, Switzerland
Kantonsspital - Saint Gallen
🇨ðŸ‡Saint Gallen, Switzerland
Newcastle General Hospital
🇬🇧Newcastle Upon Tyne, England, United Kingdom
Beatson Oncology Centre
🇬🇧Glasgow, Scotland, United Kingdom
Istituti Fisioterapici Ospitalieri - Roma
🇮🇹Rome, Italy
Academisch Ziekenhuis der Vrije Universiteit
🇳🇱Amsterdam, Netherlands
University Medical Center Nijmegen
🇳🇱Nijmegen, Netherlands
Instituto Portugues de Oncologia de Francisco Gentil
🇵🇹Lisbon, Portugal
University of Ioannina
🇬🇷Ioannina, Greece
Schneider Children's Medical Center of Israel
🇮🇱Petah-Tikva, Israel
Institut Gustave Roussy
🇫🇷Villejuif, France
Academisch Ziekenhuis Groningen
🇳🇱Groningen, Netherlands
Ospedale San Giovanni
🇨ðŸ‡Bellinzona, Switzerland
Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom