Combination Chemotherapy in Treating Men With Germ Cell Cancer

Last updated: March 5, 2012
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Overall Status: Trial Status Unknown

Phase

2/3

Condition

Germ Cell Tumors

Cancer/tumors

Neoplasms

Treatment

N/A

Clinical Study ID

NCT00003643
EORTC-30983
EORTC-30983
  • Ages 16-50
  • Male

Study Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy may be more effective for germ cell cancer.

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.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS:

  • 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

Study Design

Total Participants: 498
Study Start date:
October 01, 1998
Estimated Completion Date:

Study Description

OBJECTIVES:

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.

Connect with a study center

  • Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital

    Vienna, A-1100
    Austria

    Site Not Available

  • Institut Jules Bordet

    Brussels, 1000
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650
    Belgium

    Site Not Available

  • U.Z. Gasthuisberg

    Leuven, B-3000
    Belgium

    Site Not Available

  • Aarhus Universitetshospital - Aarhus Sygehus

    Aarhus, DK-8000
    Denmark

    Site Not Available

  • Rigshospitalet - Copenhagen University Hospital

    Copenhagen, 2100
    Denmark

    Site Not Available

  • Centre Regional Francois Baclesse

    Caen, 14076
    France

    Site Not Available

  • Institut Claudius Regaud

    Toulouse, 31052
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif, F-94805
    France

    Site Not Available

  • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, D-12200
    Germany

    Site Not Available

  • Universitaetsklinikum Bonn

    Bonn, D-53105
    Germany

    Site Not Available

  • St. Johannes Hospital - Medical Klinik II

    Duisburg, D-47166
    Germany

    Site Not Available

  • Universitaetsklinikum Essen

    Essen, D-45122
    Germany

    Site Not Available

  • Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet

    Greifswald, D-17487
    Germany

    Site Not Available

  • Allgemeines Krankenhaus Hagen

    Hagen, D-58095
    Germany

    Site Not Available

  • Universitaetsklinikum Halle

    Halle, DOH-06112
    Germany

    Site Not Available

  • University Medical Center Hamburg - Eppendorf

    Hamburg, D-20246
    Germany

    Site Not Available

  • Universitaetsklinikum des Saarlandes

    Homburg, D-66421
    Germany

    Site Not Available

  • Klinikum Kassel

    Kassel, D-34125
    Germany

    Site Not Available

  • Klinikum der Stadt Ludwigshafen am Rhein

    Ludwigshafen am Rhein, D-67063
    Germany

    Site Not Available

  • Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

    Magdeburg, D-39120
    Germany

    Site Not Available

  • Klinikum der Stadt Mannheim

    Mannheim, D-68135
    Germany

    Site Not Available

  • Universitaetsklinikum Giessen und Marburg GmbH - Marburg

    Marburg, D-35033
    Germany

    Site Not Available

  • Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster

    Muenster, D-48149
    Germany

    Site Not Available

  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen

    Munich, D-81675
    Germany

    Site Not Available

  • Klinikum Nuernberg - Klinikum Nord

    Nuremberg, D-90419
    Germany

    Site Not Available

  • Klinikum der Universitaet Regensburg

    Regensburg, D-93053
    Germany

    Site Not Available

  • Klinikum Schwerin

    Schwerin, D-19049
    Germany

    Site Not Available

  • Southwest German Cancer Center at Eberhard-Karls-University

    Tuebingen, D-72076
    Germany

    Site Not Available

  • National Institute of Oncology

    Budapest, 1125
    Hungary

    Site Not Available

  • Assaf Harofeh Medical Center

    Zerifin, 70300
    Israel

    Site Not Available

  • Ospedale di Circolo e Fondazione Macchi

    Varese, 21100
    Italy

    Site Not Available

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5211 NL
    Netherlands

    Site Not Available

  • Academisch Medisch Centrum at University of Amsterdam

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Leiden University Medical Center

    Leiden, 2300 CA
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum St. Radboud - Nijmegen

    Nijmegen, NL-6500 HB
    Netherlands

    Site Not Available

  • Daniel Den Hoed Cancer Center at Erasmus Medical Center

    Rotterdam, 3008 AE
    Netherlands

    Site Not Available

  • University Medical Center Rotterdam at Erasmus Medical Center

    Rotterdam, 3000 CA
    Netherlands

    Site Not Available

  • University Medical Center Utrecht

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

  • Norwegian Radium Hospital

    Oslo, N-0310
    Norway

    Site Not Available

  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw

    Warsaw, 02 781
    Poland

    Site Not Available

  • National Cancer Institute - Bratislava

    Bratislava, 833 10
    Slovakia

    Site Not Available

  • Hospital de la Santa Cruz i Sant Pau

    Barcelona, 08025
    Spain

    Site Not Available

  • Institut Catala D'Oncologia

    Barcelona, 08907
    Spain

    Site Not Available

  • Vall d'Hebron University Hospital

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Victoria

    Malaga, 29010
    Spain

    Site Not Available

  • Hospital Sant Joan de Reus

    Reus, 43201
    Spain

    Site Not Available

  • Hospital Universidad Virgen Del Rocio

    Sevilla, E- 41013
    Spain

    Site Not Available

  • Hospital Universitario La Fe

    Valencia, 46009
    Spain

    Site Not Available

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009
    Spain

    Site Not Available

  • Addenbrooke's Hospital

    Cambridge, England CB2 2QQ
    United Kingdom

    Site Not Available

  • Gloucestershire Oncology Centre at Cheltenham General Hospital

    Cheltenham, England GL53 7AN
    United Kingdom

    Site Not Available

  • Leeds Cancer Centre at St. James's University Hospital

    Leeds, England LS9 7TF
    United Kingdom

    Site Not Available

  • Saint Bartholomew's Hospital

    London, England EC1A 7BE
    United Kingdom

    Site Not Available

  • University College Hospital - London

    London, England WC1E 6AU
    United Kingdom

    Site Not Available

  • Christie Hospital

    Manchester, England M20 4BX
    United Kingdom

    Site Not Available

  • Nottingham City Hospital NHS Trust

    Nottingham, England NG5 1PB
    United Kingdom

    Site Not Available

  • Rosemere Cancer Centre at Royal Preston Hospital

    Preston, England PR2 9HT
    United Kingdom

    Site Not Available

  • Berkshire Cancer Centre at Royal Berkshire Hospital

    Reading, England RG1 5AN
    United Kingdom

    Site Not Available

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England S1O 2SJ
    United Kingdom

    Site Not Available

  • Royal South Hants Hospital

    Southampton, England SO14 0YG
    United Kingdom

    Site Not Available

  • Royal Marsden - Surrey

    Sutton, England SM2 5PT
    United Kingdom

    Site Not Available

  • Southend University Hospital NHS Foundation Trust

    Westcliff-On-Sea, England SS0 0RY
    United Kingdom

    Site Not Available

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland AB25 2ZN
    United Kingdom

    Site Not Available

  • Gartnavel General Hospital

    Glasgow, Scotland G12 0YN
    United Kingdom

    Site Not Available

  • Western Infirmary

    Glasgow, Scotland G11 6NT
    United Kingdom

    Site Not Available

  • Velindre Cancer Center at Velindre Hospital

    Cardiff, Wales CF4 7XL
    United Kingdom

    Site Not Available

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