Combination Chemotherapy in Treating Men With Germ Cell Cancer

NCT00003643 | Unknown Phase 2

• 1 other identifier: EORTC-30983
• Study Type: interventional
• Target: 498
• Locations: 14 countries
• Sites: 69

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Failure-free survival as measured by Logrank

Secondary Outcomes (5)

• 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

Interventions

bleomycin sulfate BIOLOGICAL

filgrastim BIOLOGICAL

cisplatin DRUG

etoposide DRUG

paclitaxel DRUG

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (69)

Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital

Vienna, A-1100, Austria

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Aarhus Universitetshospital - Aarhus Sygehus

Aarhus, DK-8000, Denmark

Location

Rigshospitalet - Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

Berlin, D-12200, Germany

Location

Universitaetsklinikum Bonn

Bonn, D-53105, Germany

Location

St. Johannes Hospital - Medical Klinik II

Duisburg, D-47166, Germany

Location

Universitaetsklinikum Essen

Essen, D-45122, Germany

Location

Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet

Greifswald, D-17487, Germany

Location

Allgemeines Krankenhaus Hagen

Hagen, D-58095, Germany

Location

Universitaetsklinikum Halle

Halle, DOH-06112, Germany

Location

University Medical Center Hamburg - Eppendorf

Hamburg, D-20246, Germany

Location

Universitaetsklinikum des Saarlandes

Homburg, D-66421, Germany

Location

Klinikum Kassel

Kassel, D-34125, Germany

Location

Klinikum der Stadt Ludwigshafen am Rhein

Ludwigshafen am Rhein, D-67063, Germany

Location

Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

Magdeburg, D-39120, Germany

Location

Klinikum der Stadt Mannheim

Mannheim, D-68135, Germany

Location

Universitaetsklinikum Giessen und Marburg GmbH - Marburg

Marburg, D-35033, Germany

Location

Klinikum Rechts Der Isar - Technische Universitaet Muenchen

Munich, D-81675, Germany

Location

Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster

Münster, D-48149, Germany

Location

Klinikum Nuernberg - Klinikum Nord

Nuremberg, D-90419, Germany

Location

Klinikum der Universitaet Regensburg

Regensburg, D-93053, Germany

Location

Klinikum Schwerin

Schwerin, D-19049, Germany

Location

Southwest German Cancer Center at Eberhard-Karls-University

Tübingen, D-72076, Germany

Location

National Institute of Oncology

Budapest, 1125, Hungary

Location

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5211 NL, Netherlands

Location

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

University Medical Center Rotterdam at Erasmus Medical Center

Rotterdam, 3000 CA, Netherlands

Location

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Rotterdam, 3008 AE, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw

Warsaw, 02 781, Poland

Location

National Cancer Institute - Bratislava

Bratislava, 833 10, Slovakia

Location

Hospital de la Santa Cruz i Sant Pau

Barcelona, 08025, Spain

Location

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

Location

Institut Catala D'Oncologia

Barcelona, 08907, Spain

Location

Hospital Universitario San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Sant Joan de Reus

Reus, 43201, Spain

Location

Hospital Universidad Virgen Del Rocio

Seville, E- 41013, Spain

Location

Hospital Universitario La Fe

Valencia, 46009, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Gloucestershire Oncology Centre at Cheltenham General Hospital

Cheltenham, England, GL53 7AN, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

University College Hospital - London

London, England, WC1E 6AU, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Rosemere Cancer Centre at Royal Preston Hospital

Preston, England, PR2 9HT, United Kingdom

Location

Berkshire Cancer Centre at Royal Berkshire Hospital

Reading, England, RG1 5AN, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Royal South Hants Hospital

Southampton, England, SO14 0YG, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Southend University Hospital NHS Foundation Trust

Westcliff-on-Sea, England, SS0 0RY, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Western Infirmary

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Gartnavel General Hospital

Glasgow, Scotland, G12 0YN, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF4 7XL, United Kingdom

Location

MeSH Terms

Conditions

Teratoma; Testicular Germ Cell Tumor; Testicular Neoplasms; Seminoma; Endodermal Sinus Tumor; Carcinoma, Embryonal

Interventions

Bleomycin; Filgrastim; Cisplatin; Etoposide; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Germinoma; Mesonephroma

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Proteins; Biological Factors; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Ronald De Wit, MD, PhD

  Daniel Den Hoed Cancer Center at Erasmus Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: October 1, 1998
• Last Updated: March 6, 2012

Record last verified: 2012-03

Locations

FR (3); IL (1); DK (2); IT (1); NL (7); AU (1); NO (1); GB (17); DE (20); BE (3); SL (1); HU (1); PL (1); ES (10)