search
Back to results

Combination Chemotherapy in Treating Men With Germ Cell Cancer

Primary Purpose

Extragonadal Germ Cell Tumor, Teratoma, Testicular Germ Cell Tumor

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
bleomycin sulfate
filgrastim
cisplatin
etoposide
paclitaxel
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extragonadal Germ Cell Tumor focused on measuring stage III malignant testicular germ cell tumor, testicular seminoma, testicular embryonal carcinoma, testicular choriocarcinoma, testicular yolk sac tumor, testicular embryonal carcinoma and teratoma, testicular embryonal carcinoma and teratoma with seminoma, testicular embryonal carcinoma and yolk sac tumor, testicular embryonal carcinoma and yolk sac tumor with seminoma, testicular embryonal carcinoma and seminoma, testicular yolk sac tumor and teratoma, testicular yolk sac tumor and teratoma with seminoma, testicular choriocarcinoma and yolk sac tumor, testicular choriocarcinoma and embryonal carcinoma, testicular choriocarcinoma and teratoma, testicular choriocarcinoma and seminoma, stage IV extragonadal non-seminomatous germ cell tumor, stage IV extragonadal seminoma, testicular immature teratoma, testicular mature teratoma, adult teratoma

Eligibility Criteria

16 Years - 50 Years (Child, Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
  • Institut Jules Bordet
  • Universitair Ziekenhuis Antwerpen
  • U.Z. Gasthuisberg
  • Aarhus Universitetshospital - Aarhus Sygehus
  • Rigshospitalet - Copenhagen University Hospital
  • Centre Regional Francois Baclesse
  • Institut Claudius Regaud
  • Institut Gustave Roussy
  • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
  • Universitaetsklinikum Bonn
  • St. Johannes Hospital - Medical Klinik II
  • Universitaetsklinikum Essen
  • Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
  • Allgemeines Krankenhaus Hagen
  • Universitaetsklinikum Halle
  • University Medical Center Hamburg - Eppendorf
  • Universitaetsklinikum des Saarlandes
  • Klinikum Kassel
  • Klinikum der Stadt Ludwigshafen am Rhein
  • Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
  • Klinikum der Stadt Mannheim
  • Universitaetsklinikum Giessen und Marburg GmbH - Marburg
  • Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen
  • Klinikum Nuernberg - Klinikum Nord
  • Klinikum der Universitaet Regensburg
  • Klinikum Schwerin
  • Southwest German Cancer Center at Eberhard-Karls-University
  • National Institute of Oncology
  • Assaf Harofeh Medical Center
  • Ospedale di Circolo e Fondazione Macchi
  • Jeroen Bosch Ziekenhuis
  • Academisch Medisch Centrum at University of Amsterdam
  • Leiden University Medical Center
  • Universitair Medisch Centrum St. Radboud - Nijmegen
  • University Medical Center Rotterdam at Erasmus Medical Center
  • Daniel Den Hoed Cancer Center at Erasmus Medical Center
  • University Medical Center Utrecht
  • Norwegian Radium Hospital
  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
  • National Cancer Institute - Bratislava
  • Hospital de la Santa Cruz i Sant Pau
  • Vall d'Hebron University Hospital
  • Institut Catala D'Oncologia
  • Hospital Universitario San Carlos
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario Virgen de la Victoria
  • Hospital Sant Joan de Reus
  • Hospital Universidad Virgen Del Rocio
  • Hospital Universitario La Fe
  • Hospital Clinico Universitario Lozano Blesa
  • Addenbrooke's Hospital
  • Gloucestershire Oncology Centre at Cheltenham General Hospital
  • Leeds Cancer Centre at St. James's University Hospital
  • Saint Bartholomew's Hospital
  • University College Hospital - London
  • Christie Hospital
  • Nottingham City Hospital NHS Trust
  • Rosemere Cancer Centre at Royal Preston Hospital
  • Berkshire Cancer Centre at Royal Berkshire Hospital
  • Cancer Research Centre at Weston Park Hospital
  • Royal South Hants Hospital
  • Royal Marsden - Surrey
  • Southend University Hospital NHS Foundation Trust
  • Aberdeen Royal Infirmary
  • Western Infirmary
  • Gartnavel General Hospital
  • Velindre Cancer Center at Velindre Hospital

Outcomes

Primary Outcome Measures

Failure-free survival as measured by Logrank

Secondary Outcome Measures

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

Full Information

First Posted
November 1, 1999
Last Updated
March 5, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
search

1. Study Identification

Unique Protocol Identification Number
NCT00003643
Brief Title
Combination Chemotherapy in Treating Men With Germ Cell Cancer
Official Title
Randomized Phase II/III Study of Taxol/Paclitaxel-BEP Versus BEP in Patients With Intermediate Prognosis Germ Cell Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extragonadal Germ Cell Tumor, Teratoma, Testicular Germ Cell Tumor
Keywords
stage III malignant testicular germ cell tumor, testicular seminoma, testicular embryonal carcinoma, testicular choriocarcinoma, testicular yolk sac tumor, testicular embryonal carcinoma and teratoma, testicular embryonal carcinoma and teratoma with seminoma, testicular embryonal carcinoma and yolk sac tumor, testicular embryonal carcinoma and yolk sac tumor with seminoma, testicular embryonal carcinoma and seminoma, testicular yolk sac tumor and teratoma, testicular yolk sac tumor and teratoma with seminoma, testicular choriocarcinoma and yolk sac tumor, testicular choriocarcinoma and embryonal carcinoma, testicular choriocarcinoma and teratoma, testicular choriocarcinoma and seminoma, stage IV extragonadal non-seminomatous germ cell tumor, stage IV extragonadal seminoma, testicular immature teratoma, testicular mature teratoma, adult teratoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Allocation
Randomized
Enrollment
498 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
bleomycin sulfate
Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Primary Outcome Measure Information:
Title
Failure-free survival as measured by Logrank
Secondary Outcome Measure Information:
Title
Response to treatment as measured by normalized markers without residual viable cancer after CT scan or surgery
Title
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
Title
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
Title
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
Title
Quality of life as measured by Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline, during treatment, and at years 1 and 2

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald De Wit, MD, PhD
Organizational Affiliation
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
City
Vienna
ZIP/Postal Code
A-1100
Country
Austria
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Aarhus Universitetshospital - Aarhus Sygehus
City
Aarhus
ZIP/Postal Code
DK-8000
Country
Denmark
Facility Name
Rigshospitalet - Copenhagen University Hospital
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
Facility Name
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
D-12200
Country
Germany
Facility Name
Universitaetsklinikum Bonn
City
Bonn
ZIP/Postal Code
D-53105
Country
Germany
Facility Name
St. Johannes Hospital - Medical Klinik II
City
Duisburg
ZIP/Postal Code
D-47166
Country
Germany
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
D-45122
Country
Germany
Facility Name
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
City
Greifswald
ZIP/Postal Code
D-17487
Country
Germany
Facility Name
Allgemeines Krankenhaus Hagen
City
Hagen
ZIP/Postal Code
D-58095
Country
Germany
Facility Name
Universitaetsklinikum Halle
City
Halle
ZIP/Postal Code
DOH-06112
Country
Germany
Facility Name
University Medical Center Hamburg - Eppendorf
City
Hamburg
ZIP/Postal Code
D-20246
Country
Germany
Facility Name
Universitaetsklinikum des Saarlandes
City
Homburg
ZIP/Postal Code
D-66421
Country
Germany
Facility Name
Klinikum Kassel
City
Kassel
ZIP/Postal Code
D-34125
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen am Rhein
City
Ludwigshafen am Rhein
ZIP/Postal Code
D-67063
Country
Germany
Facility Name
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
City
Magdeburg
ZIP/Postal Code
D-39120
Country
Germany
Facility Name
Klinikum der Stadt Mannheim
City
Mannheim
ZIP/Postal Code
D-68135
Country
Germany
Facility Name
Universitaetsklinikum Giessen und Marburg GmbH - Marburg
City
Marburg
ZIP/Postal Code
D-35033
Country
Germany
Facility Name
Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
D-48149
Country
Germany
Facility Name
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
City
Munich
ZIP/Postal Code
D-81675
Country
Germany
Facility Name
Klinikum Nuernberg - Klinikum Nord
City
Nuremberg
ZIP/Postal Code
D-90419
Country
Germany
Facility Name
Klinikum der Universitaet Regensburg
City
Regensburg
ZIP/Postal Code
D-93053
Country
Germany
Facility Name
Klinikum Schwerin
City
Schwerin
ZIP/Postal Code
D-19049
Country
Germany
Facility Name
Southwest German Cancer Center at Eberhard-Karls-University
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
National Institute of Oncology
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Assaf Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Ospedale di Circolo e Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
Jeroen Bosch Ziekenhuis
City
's-Hertogenbosch
ZIP/Postal Code
5211 NL
Country
Netherlands
Facility Name
Academisch Medisch Centrum at University of Amsterdam
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300 CA
Country
Netherlands
Facility Name
Universitair Medisch Centrum St. Radboud - Nijmegen
City
Nijmegen
ZIP/Postal Code
NL-6500 HB
Country
Netherlands
Facility Name
University Medical Center Rotterdam at Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
Daniel Den Hoed Cancer Center at Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3008 AE
Country
Netherlands
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Norwegian Radium Hospital
City
Oslo
ZIP/Postal Code
N-0310
Country
Norway
Facility Name
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
City
Warsaw
ZIP/Postal Code
02 781
Country
Poland
Facility Name
National Cancer Institute - Bratislava
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
Facility Name
Hospital de la Santa Cruz i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Vall d'Hebron University Hospital
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Institut Catala D'Oncologia
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Sant Joan de Reus
City
Reus
ZIP/Postal Code
43201
Country
Spain
Facility Name
Hospital Universidad Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
E- 41013
Country
Spain
Facility Name
Hospital Universitario La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Gloucestershire Oncology Centre at Cheltenham General Hospital
City
Cheltenham
State/Province
England
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Saint Bartholomew's Hospital
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
University College Hospital - London
City
London
State/Province
England
ZIP/Postal Code
WC1E 6AU
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Nottingham City Hospital NHS Trust
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Rosemere Cancer Centre at Royal Preston Hospital
City
Preston
State/Province
England
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Berkshire Cancer Centre at Royal Berkshire Hospital
City
Reading
State/Province
England
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Facility Name
Cancer Research Centre at Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Facility Name
Royal South Hants Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO14 0YG
Country
United Kingdom
Facility Name
Royal Marsden - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Southend University Hospital NHS Foundation Trust
City
Westcliff-On-Sea
State/Province
England
ZIP/Postal Code
SS0 0RY
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Western Infirmary
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Gartnavel General Hospital
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Velindre Cancer Center at Velindre Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF4 7XL
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Combination Chemotherapy in Treating Men With Germ Cell Cancer

We'll reach out to this number within 24 hrs