combination chemotherapy in treating patients with stage ii or stage iii germ cell tumors

Conditions: Extragonadal Germ Cell Tumor; Teratoma; Testicular Germ Cell Tumor

Summary: 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.

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 260 patients will be accrued for this study.

Eligibility 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

Keywords: stage ii malignant testicular germ cell tumor stage iii malignant testicular germ cell tumor testicular choriocarcinoma and embryonal carcinoma testicular choriocarcinoma and teratoma testicular choriocarcinoma and yolk sac tumor testicular choriocarcinoma testicular embryonal carcinoma and teratoma testicular embryonal carcinoma and yolk sac tumor testicular embryonal carcinoma testicular yolk sac tumor and teratoma testicular yolk sac tumor stage ii extragonadal non-seminomatous germ cell tumor stage iii extragonadal non-seminomatous germ cell tumor testicular immature teratoma testicular mature teratoma adult teratoma