RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III non-seminomatous germ cell tumors.

Condition	Treatment or Intervention	Phase
extragonadal germ cell tumor Testicular Cancer	Drug: bleomycin  Drug: cisplatin  Drug: etoposide  Drug: ifosfamide  Drug: oxaliplatin  Drug: paclitaxel  Procedure: chemotherapy	Phase III

Further Study Details: 

OBJECTIVES:

• Compare progression-free survival rates of patients with poor prognosis stage II or III non-seminomatous germ cell tumors with an unfavorable decrease of tumor markers after treatment with 1 course of bleomycin, etoposide, and cisplatin followed by subsequent treatment with 3 additional courses of bleomycin, etoposide, and cisplatin OR dose-dense sequential combination chemotherapy.
• Compare overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study.

Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients with a favorable decrease of tumor markers after 1 course of BEP receive 3 additional courses of BEP. Patients with an unfavorable decrease of tumor markers after 1 course of BEP are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive 3 additional courses of BEP.
• Arm II: Patients receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide.

PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study.

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of non-seminomatous germ cell tumors (NSGCT) as evidenced by 1 of the following criteria:
• Histologically confirmed NSGCT
• Clinical evidence of disease AND high serum human chorionic gonadotropin (HCG) or alpha-fetoprotein (AFP) levels
• Clinical stage II-III disease (disseminated disease)
• Testicular, retroperitoneal, or mediastinal primary site
• Poor prognosis disease, meeting 1 of the following criteria:
• Mediastinal primary site
• Non-pulmonary visceral metastases
• One of the following lab values:
• HCG > 50,000 UI/L
• AFP > 10,000 ng/mL
• Lactate dehydrogenase > 10 times upper limit of normal (ULN)

PATIENT CHARACTERISTICS: Age

• Over 16

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Absolute granulocyte count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 1.5 times ULN

Renal

• Creatinine clearance > 60 mL/min

Other

• No other prior malignancy except basal cell skin cancer
• No HIV positivity

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

France
      C.H.U. de Brest, Brest,  29609,  France; Recruiting
      Centre Alexis Vautrin, Vandoeuvre-les-Nancy,  54511,  France; Recruiting
      Centre Antoine Lacassagne, Nice,  06189,  France; Recruiting
      Centre Eugene Marquis, Rennes,  35042,  France; Recruiting
      Centre Henri Becquerel, Rouen,  76038,  France; Recruiting
      Centre Hospitalier de Rodez, Rodez,  12027,  France; Recruiting
      Centre Leon Berard, Lyon,  69008,  France; Recruiting
      Centre Medico-Chirurgical Foch, Suresnes,  92151,  France; Recruiting
      Centre Oscar Lambret, Lille,  59020,  France; Recruiting
      Centre Paul Papin, Angers,  49100,  France; Recruiting
      Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle, Montpellier,  34298,  France; Recruiting
      Centre Regional Francois Baclesse, Caen,  14076,  France; Recruiting
      CHU de Grenoble - Hopital de la Tronche, Grenoble,  38043,  France; Recruiting
      CRLCC Nantes - Atlantique, Nantes-Saint Herblain,  44805,  France; Recruiting
      Hopital Notre-Dame de Bon Secours, Metz,  57038,  France; Recruiting
      Hopital Tenon, Paris,  75970,  France; Recruiting
      Institut Claudius Regaud, Toulouse,  31052,  France; Recruiting
      Institut Gustave Roussy, Villejuif,  F-94805,  France; Recruiting
      Institut Jean Godinot, Reims,  51056,  France; Recruiting

Study chairs or principal investigators

Karim Fizazi, MD, PhD,  Institut Gustave Roussy   

Study ID Numbers:  CDR0000416124; FRE-FNCLCC-GETUG-13/0206; EU-20502; NCT00104676
Record last reviewed:  February 2005
Last Updated:  March 15, 2005
Record first received:  March 3, 2005
ClinicalTrials.gov Identifier:  NCT00104676
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08