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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Men With Germ Cell Cancer  Combination Chemotherapy in Treating Men With Germ Cell Cancer
Combination Chemotherapy in Treating Men With Germ Cell Cancer
For Condition: extragonadal germ cell tumor,Testicular Cancer
Status: Recruiting
Sponsor(s): EORTC Genito-Urinary Tract Cancer Cooperative Group ,
Synopsis: 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: Randomizedphase II/III trial to compare the effectiveness of two regimens of combination chemotherapy in treating men who have germ cell cancer.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/50 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RonaldWit, , Daniel Den Hoed Cancer Center at Erasmus Medical Center
Bristol Haematology and Oncology Centre *Recruiting*
Bristol, England, BS2 8ED
United Kingdom
Recruiting Contact Person 44-117-923-0000
Academisch Medisch Centrum *Recruiting*
Amsterdam, , 1105 AZ
Netherlands
Recruiting Contact Person 31-20-566-9111
Norwegian Radium Hospital *Recruiting*
Oslo, , N-0310
Norway
Recruiting Contact Person 47-22-93-4000
Hospital Clinico Universitario *Recruiting*
Zaragoza, , 50009
Spain
Recruiting Contact Person 34-350-418
Hospital Universitario San Carlos *Recruiting*
Madrid, , 28040
Spain
Recruiting Contact Person 34-330-3000
Institut Catala d'Oncologia - Hospital Duran i Reynals *Recruiting*
Barcelona, , 08907
Spain
Recruiting Contact Person 34-3-357-652
Hospital Sant Joan de Reus *Recruiting*
Reus, , 43201
Spain
Recruiting Contact Person 34-977-310-300
Hospital Universitario 12 de Octubre *Recruiting*
Madrid, , 28041
Spain
Recruiting Contact Person 34-390-8003
St. Johannes Hospital - Medical Klinik II *Recruiting*
Duisburg, , D-47166
Germany
Recruiting Contact Person 49-203-546-2480
Charite - Universitaetsmedizin Berlin *Recruiting*
Berlin, , D-12200
Germany
Recruiting Contact Person 49-30-7980
Klinikum der Universitaet Regensburg *Recruiting*
Regensburg, , D-93053
Germany
Recruiting Contact Person 49-941-7047-7110
Universitair Ziekenhuis Antwerpen *Recruiting*
Edegem, , B-2650
Belgium
Recruiting Contact Person 32-03-821-3300
Klinikum der Stadt Ludwigshafen am Rhein *Recruiting*
Ludwigshafen am Rhein, , D-67063
Germany
Recruiting Contact Person 49-621-503-3800
Universitaetsklinikum Essen *Recruiting*
ESSEN, , D-45122
Germany
Recruiting Contact Person 49-201-72-311
Saint Bartholomew's Hospital *Recruiting*
London, England, EC1A 7BE
United Kingdom
Recruiting Contact Person 44-207-601-8391
Klinikum Schwerin *Recruiting*
Schwerin, , D-19049
Germany
Recruiting Contact Person 49-385-892-6601
Institut Claudius Regaud *Recruiting*
Toulouse, , 31052
France
Recruiting Contact Person 33-5-6142-4242
Institut Jules Bordet *Recruiting*
Brussels, , 1000
Belgium
Recruiting Contact Person 32-2-541-3111
University Hospital - Rotterdam Dijkzigt *Recruiting*
Rotterdam, , 3000 CA
Netherlands
Recruiting Contact Person 31-10-463-9222
Martin Luther Universitaet *Recruiting*
Halle, , DOH-06112
Germany
Recruiting Contact Person 49-345-5570
Daniel Den Hoed Cancer Center at Erasmus Medical Center *Recruiting*
Rotterdam, , 3008 AE
Netherlands
Recruiting Contact Person 31-10-439-1911
Academisch Ziekenhuis Utrecht *Recruiting*
Utrecht, , 3584 CX
Netherlands
Recruiting Contact Person 31-30-250-9111
Klinikum Nuernberg - Klinikum Nord *Recruiting*
Nuremberg, , D-90419
Germany
Recruiting Contact Person 49-911-398-2460
Universitatsklinik - Saarland *Recruiting*
Homburg, , D-66421
Germany
Recruiting Contact Person 49-6841-162-3002
Centre Regional Francois Baclesse *Recruiting*
Caen, , 14076
France
Recruiting Contact Person 33-2-3145-5000
Kaiser Franz Josef Hospital *Recruiting*
Vienna, , A-1100
Austria
Recruiting Contact Person 43-1-601-9152
Institut Gustave Roussy *Recruiting*
Villejuif, , F-94805
France
Recruiting Contact Person 33-1-4211-4211
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology *Recruiting*
Warsaw, , 02 781
Poland
Recruiting Contact Person 48-22-546-2169
University of Marburg *Recruiting*
Marburg, , D-35033
Germany
Recruiting Contact Person 49-6421-286-2768
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Contact Person 32-16-33-2211
Assaf Harofeh Medical Center *Recruiting*
Zerifin, , 70300
Israel
Recruiting Contact Person 972-3-964-8040
Universitaetsklinikum Bonn *Recruiting*
Bonn, , D-53105
Germany
Recruiting Contact Person 49-228-280-3816
Hospital Clinico Universitario - Malaga *Recruiting*
Malaga, , 29010
Spain
Recruiting Contact Person 34-264-9483
Groot Ziekengasthuis 's-Hertogenbosch *Recruiting*
's-Hertogenbosch, , 5211 NL
Netherlands
Recruiting Contact Person 31-73-611-2446
Velindre Cancer Center at Velinde Hospital *Recruiting*
Cardiff, Wales, CF4 7XL
United Kingdom
Recruiting Contact Person 44-29-2061-5888
Westfaelische Wilhelms-Universitaet *Recruiting*
Muenster, , DOH-48149
Germany
Recruiting Contact Person 49-251-836-504
Aarhus Kommunehospital *Recruiting*
Aarhus, , DK-8000
Denmark
Recruiting Contact Person 45-8-612-5555
Rigshospitalet *Recruiting*
Copenhagen, , 2100
Denmark
Recruiting Contact Person 45-3-545-4268
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet *Recruiting*
Greifswald, , D-17487
Germany
Recruiting Contact Person 49-3834-77-951
Klinikum der Stadt Mannheim *Recruiting*
Mannheim, , D-68135
Germany
Recruiting Contact Person 49-621-383-2344
Hospital Universitario LA FE *Recruiting*
Valencia, , 46009
Spain
Recruiting Contact Person 34-386-2700
Universitaets-Krankenhaus Eppendorf *Recruiting*
Hamburg, , D-20246
Germany
Recruiting Contact Person 49-40-428-030
Johannes Gutenberg University *Recruiting*
Mainz, , D-55101
Germany
Recruiting Contact Person 49-6131-17-7281
Hospital Universidad Virgen Del Rocio *Recruiting*
Sevilla, , E- 41013
Spain
Recruiting Contact Person 34-4248-8181
Hospital General Universitari Vall d'Hebron *Recruiting*
Barcelona, , 08035
Spain
Recruiting Contact Person 34-3-274-6077
Ospedale di Circolo e Fondazione Macchi *Recruiting*
Varese, , 21100
Italy
Recruiting Contact Person 39-332-278-111
St. James's University Hospital *Recruiting*
Leeds, England, LS9 7TF
United Kingdom
Recruiting Contact Person 44-113-206-4904
Allgemeines Krankenhaus Hagen *Recruiting*
Hagen, , D-58095
Germany
Recruiting Contact Person 49-2331-2010
Leiden University Medical Center *Recruiting*
Leiden, , 2300 CA
Netherlands
Recruiting Contact Person 31-71-526-911
Northern Centre for Cancer Treatment at Newcastle General Hospital *Recruiting*
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
Recruiting Contact Person 44-191-273-8811
Klinikum Kassel *Recruiting*
Kassel, , D-34125
Germany
Recruiting Contact Person 49-561-80-333
Klinikum Rechts Der Isar - Technische Universitaet Muenchen *Recruiting*
Munich, , D-81675
Germany
Recruiting Contact Person 49-89-4140-4110
Western Infirmary *Recruiting*
Glasgow, Scotland, G11 6NT
United Kingdom
Recruiting Contact Person 44-141-330-4006
Academisch Ziekenhuis Groningen *Recruiting*
Groningen, , 9713 EZ
Netherlands
Recruiting Contact Person 31-50-361-6161
Otto - Von - Guericke - Universitaet Magdeburg *Recruiting*
Magdeburg, , D-39120
Germany
Recruiting Contact Person 49-391-67-2500
University Medical Center Nijmegen *Recruiting*
Nijmegen, , NL-6500 HB
Netherlands
Recruiting Contact Person 31-24-361-1111
National Institute of Oncology *Recruiting*
Budapest, , 1125
Hungary
Recruiting Contact Person 36-1-355-4411
Universitats-Hautklinik Eberhard - Karls Universitat *Recruiting*
Tuebingen, , DOH-72076
Germany
Recruiting Contact Person 49-70-7129-4574
Hospital de la Santa Cruz I Sant Pau *Recruiting*
Barcelona, , 08025
Spain
Recruiting Contact Person 34-3-47-3133
Additional Information:
Study ID Numbers: CDR0000066731; EORTC-30983
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003643
Other Extragonadal Germ Cell Tumor Studies:
1. Combination Chemotherapy With Bone Marrow Transplantation in Treating Men With Germ Cell Tumors
2. Combination Chemotherapy Followed by Bone Marrow or Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Germ Cell Tumors
3. Combination Chemotherapy in Treating Men With Germ Cell Cancer
4. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors
5. Arsenic Trioxide in Treating Men With Germ Cell Cancer
Related Studies:
Other extragonadal germ cell tumor Clinical Trials
Other Clinical Trials
Other Hamburg Clinical Trials
Combination Chemotherapy in Treating Men With Germ Cell Cancer
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