Combination Chemotherapy in Treating Men With Germ Cell Cancer

March 5, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Randomized Phase II/III Study of Taxol/Paclitaxel-BEP Versus BEP in Patients With Intermediate Prognosis Germ Cell Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

498

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1100
        • Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
  • Belgium
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Edegem, Belgium, B-2650
        • Universitair Ziekenhuis Antwerpen
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
  • Denmark
      • Aarhus, Denmark, DK-8000
        • Aarhus Universitetshospital - Aarhus Sygehus
      • Copenhagen, Denmark, 2100
        • Rigshospitalet - Copenhagen University Hospital
  • France
      • Caen, France, 14076
        • Centre Regional Francois Baclesse
      • Toulouse, France, 31052
        • Institut Claudius Regaud
      • Villejuif, France, F-94805
        • Institut Gustave Roussy
  • Germany
      • Berlin, Germany, D-12200
        • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
      • Bonn, Germany, D-53105
        • Universitaetsklinikum Bonn
      • Duisburg, Germany, D-47166
        • St. Johannes Hospital - Medical Klinik II
      • Essen, Germany, D-45122
        • Universitaetsklinikum Essen
      • Greifswald, Germany, D-17487
        • Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
      • Hagen, Germany, D-58095
        • Allgemeines Krankenhaus Hagen
      • Halle, Germany, DOH-06112
        • Universitaetsklinikum Halle
      • Hamburg, Germany, D-20246
        • University Medical Center Hamburg - Eppendorf
      • Homburg, Germany, D-66421
        • Universitaetsklinikum des Saarlandes
      • Kassel, Germany, D-34125
        • Klinikum Kassel
      • Ludwigshafen am Rhein, Germany, D-67063
        • Klinikum der Stadt Ludwigshafen am Rhein
      • Magdeburg, Germany, D-39120
        • Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
      • Mannheim, Germany, D-68135
        • Klinikum der Stadt Mannheim
      • Marburg, Germany, D-35033
        • Universitaetsklinikum Giessen und Marburg GmbH - Marburg
      • Muenster, Germany, D-48149
        • Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
      • Munich, Germany, D-81675
        • Klinikum rechts der Isar - Technische Universitaet Muenchen
      • Nuremberg, Germany, D-90419
        • Klinikum Nuernberg - Klinikum Nord
      • Regensburg, Germany, D-93053
        • Klinikum der Universitaet Regensburg
      • Schwerin, Germany, D-19049
        • Klinikum Schwerin
      • Tuebingen, Germany, D-72076
        • Southwest German Cancer Center at Eberhard-Karls-University
  • Hungary
      • Budapest, Hungary, 1125
        • National Institute of Oncology
  • Israel
      • Zerifin, Israel, 70300
        • Assaf Harofeh Medical Center
  • Italy
      • Varese, Italy, 21100
        • Ospedale di Circolo e Fondazione Macchi
  • Netherlands
      • 's-Hertogenbosch, Netherlands, 5211 NL
        • Jeroen Bosch Ziekenhuis
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum at University of Amsterdam
      • Leiden, Netherlands, 2300 CA
        • Leiden University Medical Center
      • Nijmegen, Netherlands, NL-6500 HB
        • Universitair Medisch Centrum St. Radboud - Nijmegen
      • Rotterdam, Netherlands, 3000 CA
        • University Medical Center Rotterdam at Erasmus Medical Center
      • Rotterdam, Netherlands, 3008 AE
        • Daniel Den Hoed Cancer Center at Erasmus Medical Center
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht
  • Norway
      • Oslo, Norway, N-0310
        • Norwegian Radium Hospital
  • Poland
      • Warsaw, Poland, 02 781
        • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
  • Slovakia
      • Bratislava, Slovakia, 833 10
        • National Cancer Institute - Bratislava
  • Spain
      • Barcelona, Spain, 08907
        • Institut Catala d'Oncologia
      • Barcelona, Spain, 08025
        • Hospital de la Santa Cruz i Sant Pau
      • Barcelona, Spain, 08035
        • Vall d'Hebron University Hospital
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28040
        • Hospital Universitario San Carlos
      • Malaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Reus, Spain, 43201
        • Hospital Sant Joan de Reus
      • Sevilla, Spain, E- 41013
        • Hospital Universidad Virgen Del Rocio
      • Valencia, Spain, 46009
        • Hospital Universitario La Fe
      • Zaragoza, Spain, 50009
        • Hospital Clinico Universitario Lozano Blesa
  • United Kingdom
    • England
      • Cambridge, England, United Kingdom, CB2 2QQ
        • Addenbrooke's Hospital
      • Cheltenham, England, United Kingdom, GL53 7AN
        • Gloucestershire Oncology Centre at Cheltenham General Hospital
      • Leeds, England, United Kingdom, LS9 7TF
        • Leeds Cancer Centre at St. James's University Hospital
      • London, England, United Kingdom, EC1A 7BE
        • Saint Bartholomew's Hospital
      • London, England, United Kingdom, WC1E 6AU
        • University College Hospital - London
      • Manchester, England, United Kingdom, M20 4BX
        • Christie Hospital
      • Nottingham, England, United Kingdom, NG5 1PB
        • Nottingham City Hospital NHS Trust
      • Preston, England, United Kingdom, PR2 9HT
        • Rosemere Cancer Centre at Royal Preston Hospital
      • Reading, England, United Kingdom, RG1 5AN
        • Berkshire Cancer Centre at Royal Berkshire Hospital
      • Sheffield, England, United Kingdom, S1O 2SJ
        • Cancer Research Centre at Weston Park Hospital
      • Southampton, England, United Kingdom, SO14 0YG
        • Royal South Hants Hospital
      • Sutton, England, United Kingdom, SM2 5PT
        • Royal Marsden - Surrey
      • Westcliff-On-Sea, England, United Kingdom, SS0 0RY
        • Southend University Hospital NHS Foundation Trust
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary
      • Glasgow, Scotland, United Kingdom, G11 6NT
        • Western Infirmary
      • Glasgow, Scotland, United Kingdom, G12 0YN
        • Gartnavel General Hospital
    • Wales
      • Cardiff, Wales, United Kingdom, CF4 7XL
        • Velindre Cancer Center at Velindre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 50 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Failure-free survival as measured by Logrank

Secondary Outcome Measures

Outcome Measure
Response to treatment as measured by normalized markers without residual viable cancer after CT scan or surgery
Overall survival as measured by Logrank at end of each course, at 6 weeks after completion of study treatment, every 6 months up to year 5, and then annually thereafter
Disease-free survival as measured by Logrank at end of each course, at 6 weeks after completion of study treatment, every 6 months up to year 5, and then annually thereafter
Toxicity as measured by NCI-CTC v2.0 at end of each course, at 6 weeks after completion of study treatment, every 6 months up to year 5, and then annually thereafter
Quality of life as measured by Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline, during treatment, and at years 1 and 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1998

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

March 6, 2012

Last Update Submitted That Met QC Criteria

March 5, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-30983

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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