Combination Chemotherapy in Treating Men With Germ Cell Cancer
NCT ID: NCT00003643
Last Updated: 2012-03-06
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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UNKNOWN
PHASE2/PHASE3
498 participants
INTERVENTIONAL
1998-10-31
Brief Summary
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PURPOSE: This randomized phase II/III trial is studying two different regimens of combination chemotherapy and comparing how well they work in treating men with germ cell cancer.
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Detailed Description
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Phase II
* Compare the complete response rates in men with intermediate prognosis germ cell cancer treated with bleomycin, cisplatin, and etoposide (BEP) vs bleomycin, cisplatin, etoposide, and paclitaxel (T-BEP).
* Define the toxicity profile of T-BEP in these patients.
Phase III
* Compare the disease-free survival of patients treated with these regimens.
* Compare the complete response rates and overall survival of patients treated with these regimens.
* Compare symptoms and aspects of quality of life at baseline and after treatment in patients treated with these regimens.
* Compare the acute and intermediate (1-2 years) side effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to histology (seminoma vs non-seminoma) and hospital. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive cisplatin IV and etoposide IV on days 1-5 and bleomycin IV on days 1, 8, and 15.
* Arm II: Patients receive cisplatin, etoposide, and bleomycin as in arm I and paclitaxel IV over 3 hours on day 1. Patients also receive filgrastim (G-CSF) subcutaneously on days 6-15.
In both arms, treatment repeats every 3 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed before treatment randomization and at 1 and 2 years after randomization.
Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 84-164 patients (42-82 per treatment arm) will be accrued for the phase II study. A total of 498 patients (249 per treatment arm) will be accrued for the phase III study. Accrual will be completed within 4 years.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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bleomycin sulfate
filgrastim
cisplatin
etoposide
paclitaxel
Eligibility Criteria
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Inclusion Criteria
* Histologically proven germ cell cancer
* Seminoma
* Non-seminoma
* Combined
* Intermediate prognosis
* Non-seminoma:
* Testis/retroperitoneal primary
* No non-pulmonary visceral metastases
* Meets 1 of the following criteria:
* Alpha-fetoprotein (AFP) 1,000- 10,000 IU/L
* Human chorionic gonadotropin (hCG) 5,000-50,000 IU/L
* Lactic dehydrogenase (LDH) 1.5 times-10 times upper limit of normal (ULN)
* Seminoma:
* Any primary site
* Any LDH and HCG
* AFP normal
* Non-pulmonary visceral metastases present
PATIENT CHARACTERISTICS:
Age:
* 16 to 50
Sex:
* Male
Performance status:
* WHO 0-2
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.25 times ULN
* AST no greater than 2 times ULN
Renal:
* Creatinine clearance at least 40 mL/min (unless due to obstructive uropathy which can be relieved by nephrostomy)
Other:
* No pre-existing neuropathy
* No other malignancy except basal cell skin cancer
* No other serious illness or medical conditions incompatible with the protocol
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
16 Years
50 Years
MALE
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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Ronald De Wit, MD, PhD
Role: STUDY_CHAIR
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Locations
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Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
Vienna, , Austria
Institut Jules Bordet
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Aarhus Universitetshospital - Aarhus Sygehus
Aarhus, , Denmark
Rigshospitalet - Copenhagen University Hospital
Copenhagen, , Denmark
Centre Regional Francois Baclesse
Caen, , France
Institut Claudius Regaud
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, , Germany
Universitaetsklinikum Bonn
Bonn, , Germany
St. Johannes Hospital - Medical Klinik II
Duisburg, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, , Germany
Allgemeines Krankenhaus Hagen
Hagen, , Germany
Universitaetsklinikum Halle
Halle, , Germany
University Medical Center Hamburg - Eppendorf
Hamburg, , Germany
Universitaetsklinikum des Saarlandes
Homburg, , Germany
Klinikum Kassel
Kassel, , Germany
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen am Rhein, , Germany
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, , Germany
Klinikum der Stadt Mannheim
Mannheim, , Germany
Universitaetsklinikum Giessen und Marburg GmbH - Marburg
Marburg, , Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, , Germany
Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
Münster, , Germany
Klinikum Nuernberg - Klinikum Nord
Nuremberg, , Germany
Klinikum der Universitaet Regensburg
Regensburg, , Germany
Klinikum Schwerin
Schwerin, , Germany
Southwest German Cancer Center at Eberhard-Karls-University
Tübingen, , Germany
National Institute of Oncology
Budapest, , Hungary
Assaf Harofeh Medical Center
Ẕerifin, , Israel
Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Universitair Medisch Centrum St. Radboud - Nijmegen
Nijmegen, , Netherlands
University Medical Center Rotterdam at Erasmus Medical Center
Rotterdam, , Netherlands
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
Norwegian Radium Hospital
Oslo, , Norway
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
Warsaw, , Poland
National Cancer Institute - Bratislava
Bratislava, , Slovakia
Hospital de la Santa Cruz i Sant Pau
Barcelona, , Spain
Vall d'Hebron University Hospital
Barcelona, , Spain
Institut Catala D'Oncologia
Barcelona, , Spain
Hospital Universitario San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Sant Joan de Reus
Reus, , Spain
Hospital Universidad Virgen Del Rocio
Seville, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, , Spain
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom
University College Hospital - London
London, England, United Kingdom
Christie Hospital
Manchester, England, United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
Rosemere Cancer Centre at Royal Preston Hospital
Preston, England, United Kingdom
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom
Royal South Hants Hospital
Southampton, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Western Infirmary
Glasgow, Scotland, United Kingdom
Gartnavel General Hospital
Glasgow, Scotland, United Kingdom
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom
Countries
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Other Identifiers
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EORTC-30983
Identifier Type: -
Identifier Source: secondary_id
EORTC-30983
Identifier Type: -
Identifier Source: org_study_id
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