Finding studies
Finding studies
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Lead
Hoosier Cancer Research Network
With
OUTLINE: This is a multi-center trial. Subjects will be stratified prior to randomization based on previous administration of chemotherapy. Subjects will randomize to aprepitant or placebo with their first study cycle of chemotherapy and then cross over to opposite treatment with the second study cycle. Cisplatin-based regimen for germ cell tumors containing 20mg/m2/day IV days 1 through 5, first day of chemotherapy administration is day 1. Permitted treatment regimens: Regimen 1 (BEP) Cisplatin (20mg/m2/day) IV on days 1 to 5 Etoposide (100 mg/m2/day) IV on days 1 to 5 Bleomycin 30 U/IV on days 1, 8, 15 Regimen 2 (EP) Cisplatin (20mg/m2/day) IV on days 1 to 5 Etoposide (100 mg/m2/day) IV on days 1 to 5 Regimen 3 (VIP) Cisplatin (20mg/m2/day) IV on days 1 to 5 Ifosfamide (1200 mg/m2/day) IV on days 1 to 5 (with mesna uroprophylaxis at 100% ifosfamide dosing) Etoposide (75 mg/m2/day) IV on days 1 to 5 Regimen 4 (VeIP) Cisplatin (20mg/m2/day) IV on days 1 to 5 Ifosfamide (1200 mg/m2/day) IV on days 1 to 5 (with mesna uroprophylaxis at 100% ifosfamide dosing) Vinblastine (0.11 mg/kg/day) IV on days 1 and 2 Regimen 5 (EC) Cisplatin (20mg/m2/day) IV on days 1 to 5 Epirubicin (90 mg/m2/day) IV on day 1 Patients are treated on study for two cycles. At the completion of protocol therapy patients will receive additional chemotherapy at the discretion of the treating investigator. If a patient requires discontinuation of one medication or more on a regimen, the patient must be discontinued from the study. Performance Status: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin \< 3 x upper limit of normal * Aspartate aminotransferase (AST, SGOT) \< 3 x upper limit of normal * Alanine aminotransferase (ALT, SGPT) \< 3 x upper limit of normal * Alk Phos \< 3 x upper limit of normal Renal: * Serum Creatinine \<2 mg/dL Pulmonary: * Not specified
Age
15–any
Sex
MALE
Healthy volunteers
Not accepted
