Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 1 of 18 for:    "Teratoma" | "Anti-Bacterial Agents"
Previous Study | Return to List | Next Study

Combination Chemotherapy in Treating Men With Germ Cell Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003643
Recruitment Status : Unknown
Verified March 2012 by European Organisation for Research and Treatment of Cancer - EORTC.
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : March 6, 2012
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief 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.


Condition or disease Intervention/treatment Phase
Extragonadal Germ Cell Tumor Teratoma Testicular Germ Cell Tumor Biological: bleomycin sulfate Biological: filgrastim Drug: cisplatin Drug: etoposide Drug: paclitaxel Phase 2 Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 498 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Phase II/III Study of Taxol/Paclitaxel-BEP Versus BEP in Patients With Intermediate Prognosis Germ Cell Cancer
Study Start Date : October 1998





Primary Outcome Measures :
  1. Failure-free survival as measured by Logrank

Secondary Outcome Measures :
  1. Response to treatment as measured by normalized markers without residual viable cancer after CT scan or surgery
  2. 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
  3. 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
  4. 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
  5. Quality of life as measured by Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline, during treatment, and at years 1 and 2


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003643


Locations
Hide Hide 69 study locations
Layout table for location information
Austria
Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
Vienna, Austria, A-1100
Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Denmark
Aarhus Universitetshospital - Aarhus Sygehus
Aarhus, Denmark, DK-8000
Rigshospitalet - Copenhagen University Hospital
Copenhagen, Denmark, 2100
France
Centre Regional Francois Baclesse
Caen, France, 14076
Institut Claudius Regaud
Toulouse, France, 31052
Institut Gustave Roussy
Villejuif, France, F-94805
Germany
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, Germany, D-12200
Universitaetsklinikum Bonn
Bonn, Germany, D-53105
St. Johannes Hospital - Medical Klinik II
Duisburg, Germany, D-47166
Universitaetsklinikum Essen
Essen, Germany, D-45122
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, Germany, D-17487
Allgemeines Krankenhaus Hagen
Hagen, Germany, D-58095
Universitaetsklinikum Halle
Halle, Germany, DOH-06112
University Medical Center Hamburg - Eppendorf
Hamburg, Germany, D-20246
Universitaetsklinikum des Saarlandes
Homburg, Germany, D-66421
Klinikum Kassel
Kassel, Germany, D-34125
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen am Rhein, Germany, D-67063
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, Germany, D-39120
Klinikum der Stadt Mannheim
Mannheim, Germany, D-68135
Universitaetsklinikum Giessen und Marburg GmbH - Marburg
Marburg, Germany, D-35033
Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
Muenster, Germany, D-48149
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, Germany, D-81675
Klinikum Nuernberg - Klinikum Nord
Nuremberg, Germany, D-90419
Klinikum der Universitaet Regensburg
Regensburg, Germany, D-93053
Klinikum Schwerin
Schwerin, Germany, D-19049
Southwest German Cancer Center at Eberhard-Karls-University
Tuebingen, Germany, D-72076
Hungary
National Institute of Oncology
Budapest, Hungary, 1125
Israel
Assaf Harofeh Medical Center
Zerifin, Israel, 70300
Italy
Ospedale di Circolo e Fondazione Macchi
Varese, Italy, 21100
Netherlands
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands, 5211 NL
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, Netherlands, 1105 AZ
Leiden University Medical Center
Leiden, Netherlands, 2300 CA
Universitair Medisch Centrum St. Radboud - Nijmegen
Nijmegen, Netherlands, NL-6500 HB
University Medical Center Rotterdam at Erasmus Medical Center
Rotterdam, Netherlands, 3000 CA
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, Netherlands, 3008 AE
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Norway
Norwegian Radium Hospital
Oslo, Norway, N-0310
Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
Warsaw, Poland, 02 781
Slovakia
National Cancer Institute - Bratislava
Bratislava, Slovakia, 833 10
Spain
Hospital de la Santa Cruz i Sant Pau
Barcelona, Spain, 08025
Vall d'Hebron University Hospital
Barcelona, Spain, 08035
Institut Catala D'Oncologia
Barcelona, Spain, 08907
Hospital Universitario San Carlos
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario Virgen de la Victoria
Malaga, Spain, 29010
Hospital Sant Joan de Reus
Reus, Spain, 43201
Hospital Universidad Virgen Del Rocio
Sevilla, Spain, E- 41013
Hospital Universitario La Fe
Valencia, Spain, 46009
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Spain, 50009
United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, United Kingdom, GL53 7AN
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
University College Hospital - London
London, England, United Kingdom, WC1E 6AU
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom, NG5 1PB
Rosemere Cancer Centre at Royal Preston Hospital
Preston, England, United Kingdom, PR2 9HT
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, England, United Kingdom, RG1 5AN
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
Royal South Hants Hospital
Southampton, England, United Kingdom, SO14 0YG
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Southend University Hospital NHS Foundation Trust
Westcliff-On-Sea, England, United Kingdom, SS0 0RY
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Western Infirmary
Glasgow, Scotland, United Kingdom, G11 6NT
Gartnavel General Hospital
Glasgow, Scotland, United Kingdom, G12 0YN
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom, CF4 7XL
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Layout table for investigator information
Study Chair: Ronald De Wit, MD, PhD Daniel Den Hoed Cancer Center at Erasmus Medical Center

Layout table for additonal information
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00003643    
Other Study ID Numbers: EORTC-30983
EORTC-30983
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 6, 2012
Last Verified: March 2012
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
testicular embryonal carcinoma and teratoma
testicular embryonal carcinoma and teratoma with seminoma
testicular yolk sac tumor and teratoma
testicular yolk sac tumor and teratoma with seminoma
testicular choriocarcinoma and teratoma
testicular immature teratoma
testicular mature teratoma
adult teratoma
stage III malignant testicular germ cell tumor
testicular seminoma
testicular embryonal carcinoma
testicular choriocarcinoma
testicular yolk sac tumor
testicular embryonal carcinoma and yolk sac tumor
testicular embryonal carcinoma and yolk sac tumor with seminoma
testicular embryonal carcinoma and seminoma
testicular choriocarcinoma and yolk sac tumor
testicular choriocarcinoma and embryonal carcinoma
testicular choriocarcinoma and seminoma
stage IV extragonadal non-seminomatous germ cell tumor
stage IV extragonadal seminoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Teratoma
Antibiotics, Antineoplastic
Neoplasms, Germ Cell and Embryonal
Neoplasms
Neoplasms by Histologic Type
Paclitaxel
Etoposide
Albumin-Bound Paclitaxel
Bleomycin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors