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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00003643
Other study ID # EORTC-30983
Secondary ID EORTC-30983
Status Active, not recruiting
Phase Phase 2/Phase 3
First received November 1, 1999
Last updated March 5, 2012
Start date October 1998

Study information

Verified date March 2012
Source European Organisation for Research and Treatment of Cancer - EORTC
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 498
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 16 Years to 50 Years
Eligibility 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 Design

Allocation: Randomized, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
bleomycin sulfate

filgrastim

Drug:
cisplatin

etoposide

paclitaxel


Locations

Country Name City State
Austria Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital Vienna
Belgium Institut Jules Bordet Brussels
Belgium Universitair Ziekenhuis Antwerpen Edegem
Belgium U.Z. Gasthuisberg Leuven
Denmark Aarhus Universitetshospital - Aarhus Sygehus Aarhus
Denmark Rigshospitalet - Copenhagen University Hospital Copenhagen
France Centre Regional Francois Baclesse Caen
France Institut Claudius Regaud Toulouse
France Institut Gustave Roussy Villejuif
Germany Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin Berlin
Germany Universitaetsklinikum Bonn Bonn
Germany St. Johannes Hospital - Medical Klinik II Duisburg
Germany Universitaetsklinikum Essen Essen
Germany Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet Greifswald
Germany Allgemeines Krankenhaus Hagen Hagen
Germany Universitaetsklinikum Halle Halle
Germany University Medical Center Hamburg - Eppendorf Hamburg
Germany Universitaetsklinikum des Saarlandes Homburg
Germany Klinikum Kassel Kassel
Germany Klinikum der Stadt Ludwigshafen am Rhein Ludwigshafen am Rhein
Germany Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg Magdeburg
Germany Klinikum der Stadt Mannheim Mannheim
Germany Universitaetsklinikum Giessen und Marburg GmbH - Marburg Marburg
Germany Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster Muenster
Germany Klinikum Rechts Der Isar - Technische Universitaet Muenchen Munich
Germany Klinikum Nuernberg - Klinikum Nord Nuremberg
Germany Klinikum der Universitaet Regensburg Regensburg
Germany Klinikum Schwerin Schwerin
Germany Southwest German Cancer Center at Eberhard-Karls-University Tuebingen
Hungary National Institute of Oncology Budapest
Israel Assaf Harofeh Medical Center Zerifin
Italy Ospedale di Circolo e Fondazione Macchi Varese
Netherlands Jeroen Bosch Ziekenhuis 's-Hertogenbosch
Netherlands Academisch Medisch Centrum at University of Amsterdam Amsterdam
Netherlands Leiden University Medical Center Leiden
Netherlands Universitair Medisch Centrum St. Radboud - Nijmegen Nijmegen
Netherlands Daniel Den Hoed Cancer Center at Erasmus Medical Center Rotterdam
Netherlands University Medical Center Rotterdam at Erasmus Medical Center Rotterdam
Netherlands University Medical Center Utrecht Utrecht
Norway Norwegian Radium Hospital Oslo
Poland Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw Warsaw
Slovakia National Cancer Institute - Bratislava Bratislava
Spain Hospital de la Santa Cruz i Sant Pau Barcelona
Spain Institut Catala D'Oncologia Barcelona
Spain Vall d'Hebron University Hospital Barcelona
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario San Carlos Madrid
Spain Hospital Universitario Virgen de la Victoria Malaga
Spain Hospital Sant Joan de Reus Reus
Spain Hospital Universidad Virgen Del Rocio Sevilla
Spain Hospital Universitario La Fe Valencia
Spain Hospital Clinico Universitario Lozano Blesa Zaragoza
United Kingdom Aberdeen Royal Infirmary Aberdeen Scotland
United Kingdom Addenbrooke's Hospital Cambridge England
United Kingdom Velindre Cancer Center at Velindre Hospital Cardiff Wales
United Kingdom Gloucestershire Oncology Centre at Cheltenham General Hospital Cheltenham England
United Kingdom Gartnavel General Hospital Glasgow Scotland
United Kingdom Western Infirmary Glasgow Scotland
United Kingdom Leeds Cancer Centre at St. James's University Hospital Leeds England
United Kingdom Saint Bartholomew's Hospital London England
United Kingdom University College Hospital - London London England
United Kingdom Christie Hospital Manchester England
United Kingdom Nottingham City Hospital NHS Trust Nottingham England
United Kingdom Rosemere Cancer Centre at Royal Preston Hospital Preston England
United Kingdom Berkshire Cancer Centre at Royal Berkshire Hospital Reading England
United Kingdom Cancer Research Centre at Weston Park Hospital Sheffield England
United Kingdom Royal South Hants Hospital Southampton England
United Kingdom Royal Marsden - Surrey Sutton England
United Kingdom Southend University Hospital NHS Foundation Trust Westcliff-On-Sea England

Sponsors (1)

Lead Sponsor Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  France,  Germany,  Hungary,  Israel,  Italy,  Netherlands,  Norway,  Poland,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Failure-free survival as measured by Logrank No
Secondary Response to treatment as measured by normalized markers without residual viable cancer after CT scan or surgery No
Secondary 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 No
Secondary 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 No
Secondary 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 Yes
Secondary Quality of life as measured by Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline, during treatment, and at years 1 and 2 No
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