Combination Chemotherapy in Treating Men With Germ Cell Cancer

Testicular Germ Cell Tumor Clinical Trial

Official title:

Randomized Phase II/III Study of Taxol/Paclitaxel-BEP Versus BEP in Patients With Intermediate Prognosis Germ Cell Cancer

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
• 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

• Extragonadal Germ Cell Tumor
• Neoplasms, Germ Cell and Embryonal
• Teratoma
• Testicular Germ Cell Tumor
• Testicular Neoplasms

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