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Phase II/III Randomized Study of Bleomycin, Cisplatin, and Etoposide (BEP) Versus Bleomycin, Cisplatin, Etoposide, and Paclitaxel (T-BEP) in Men With Intermediate Prognosis Germ Cell Cancer
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Combination Chemotherapy in Treating Men With Germ Cell Cancer
Basic Trial Information
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Sponsor
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Protocol IDs
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Phase III, Phase II
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Treatment
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Active
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16 to 50
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Other
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EORTC-30983
NCT00003643
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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.
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
Prior/Concurrent Therapy:
Biologic therapy: Chemotherapy: Endocrine therapy: Radiotherapy: Surgery: Patient Characteristics:
Age: Sex: Performance status: Life expectancy: Hematopoietic: - WBC at least 3,000/mm3
- Platelet count at least 100,000/mm3
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
Expected Enrollment 498A 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. Outcomes Primary Outcome(s)Failure-free survival as measured by Logrank
Secondary Outcome(s)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
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.
Trial Contact Information
Trial Lead Organizations European Organization for Research and Treatment of Cancer | | | | Ronald De Wit, MD, PhD, Study coordinator | | | |
Trial Sites
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| Austria |
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Vienna |
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| | | | Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital |
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| Belgium |
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Brussels |
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| | | | Institut Jules Bordet |
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Edegem |
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| | | Universitair Ziekenhuis Antwerpen |
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Leuven |
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| | | U.Z. Gasthuisberg |
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| Denmark |
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Aarhus |
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| | | | Aarhus Universitetshospital - Aarhus Sygehus |
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Copenhagen |
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| | | Rigshospitalet - Copenhagen University Hospital |
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| France |
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Caen |
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| | | | Centre Regional Francois Baclesse |
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Toulouse |
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| | | Institut Claudius Regaud |
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Villejuif |
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| | | Institut Gustave Roussy |
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| Germany |
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Berlin |
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| | | | Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin |
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Bonn |
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| | | Universitaetsklinikum Bonn |
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Duisburg |
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| | | St. Johannes Hospital - Medical Klinik II |
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Essen |
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| | | Universitaetsklinikum Essen |
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Greifswald |
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| | | Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet |
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Hagen |
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| | | Allgemeines Krankenhaus Hagen |
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Halle |
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| | | Universitaetsklinikum Halle |
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Hamburg |
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| | | University Medical Center Hamburg - Eppendorf |
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Homburg |
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| | | Universitaetsklinikum des Saarlandes |
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Kassel |
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| | | Klinikum Kassel |
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Ludwigshafen am Rhein |
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| | | Klinikum der Stadt Ludwigshafen am Rhein |
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Magdeburg |
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| | | Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg |
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Mannheim |
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| | | Klinikum der Stadt Mannheim |
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Marburg |
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| | | Universitaetsklinikum Giessen und Marburg GmbH - Marburg |
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Muenster |
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| | | Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster |
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Munich |
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| | | Klinikum Rechts Der Isar - Technische Universitaet Muenchen |
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Nuremberg |
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| | | Klinikum Nuernberg - Klinikum Nord |
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Regensburg |
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| | | Klinikum der Universitaet Regensburg |
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Schwerin |
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| | | Klinikum Schwerin |
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Tuebingen |
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| | | Southwest German Cancer Center at Eberhard-Karls-University |
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| Hungary |
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Budapest |
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| | | | National Institute of Oncology |
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| Israel |
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Zerifin |
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| | | | Assaf Harofeh Medical Center |
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| Italy |
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Varese |
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| | | | Ospedale di Circolo e Fondazione Macchi |
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| Netherlands |
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Amsterdam |
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| | | | Academisch Medisch Centrum at University of Amsterdam |
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Leiden |
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| | | Leiden University Medical Center |
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Nijmegen |
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| | | Universitair Medisch Centrum St. Radboud - Nijmegen |
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Rotterdam |
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| | | Daniel Den Hoed Cancer Center at Erasmus Medical Center |
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| | | University Medical Center Rotterdam at Erasmus Medical Center |
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's-Hertogenbosch |
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| | | Jeroen Bosch Ziekenhuis |
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Utrecht |
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| | | University Medical Center Utrecht |
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| Norway |
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Oslo |
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| | | | Norwegian Radium Hospital |
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| Poland |
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Warsaw |
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| | | | Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw |
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| Slovakia |
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Bratislava |
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| | | | National Cancer Institute - Bratislava |
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| Spain |
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Barcelona |
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| | | | Hospital de la Santa Cruz i Sant Pau |
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| | | Institut Catala D'Oncologia |
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| | | Vall d'Hebron University Hospital |
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Madrid |
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| | | Hospital Universitario 12 de Octubre |
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| | | Hospital Universitario San Carlos |
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Malaga |
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| | | Hospital Universitario Virgen de la Victoria |
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Reus |
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| | | Hospital Sant Joan de Reus |
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Sevilla |
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| | | Hospital Universidad Virgen Del Rocio |
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Valencia |
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| | | Hospital Universitario La Fe |
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Zaragoza |
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| | | Hospital Clinico Universitario Lozano Blesa |
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| United Kingdom |
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| England |
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Cambridge |
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| | | | | Addenbrooke's Hospital |
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Cheltenham |
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| | | Cheltenham General Hospital |
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Leeds |
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| | | Leeds Cancer Centre at St. James's University Hospital |
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London |
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| | | Saint Bartholomew's Hospital |
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| | | University College Hospital - London |
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Manchester |
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| | | Christie Hospital |
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Nottingham |
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| | | Nottingham City Hospital NHS Trust |
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Preston |
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| | | Royal Preston Hospital |
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Reading |
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| | | Berkshire Cancer Centre at Royal Berkshire Hospital |
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Sheffield |
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| | | Cancer Research Centre at Weston Park Hospital |
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Southampton |
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| | | Royal South Hants Hospital |
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Sutton |
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| | | Royal Marsden - Surrey |
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Westcliff-On-Sea |
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| | | Southend University Hospital NHS Foundation Trust |
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| Scotland |
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Aberdeen |
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| | | | Aberdeen Royal Infirmary |
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Glasgow |
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| | | Gartnavel General Hospital |
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| | | Western Infirmary |
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| Wales |
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Cardiff |
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| | | | Velindre Cancer Center at Velindre Hospital |
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| Registry Information | | | Official Title | | Randomized Phase II/III Study of Taxol/Paclitaxel-BEP Versus BEP in Patients with Intermediate Prognosis Germ Cell Cancer | | | Trial Start Date | | 1998-10-14 | | | Registered in ClinicalTrials.gov | | NCT00003643 | | | Date Submitted to PDQ | | 1998-10-27 | | | Information Last Verified | | 2008-04-13 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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