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A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) With High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors
Australian & New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP)
Patients enrolled in this trial will be randomised into one of two arms. In Arm A, patients will receive 4 cycles of TIP chemotherapy, administered every 21 days. Paclitaxel will be administered intravenously at a 250mg/m^2 dose on Day 1; Ifosfamide will be administered intravenously at a 1500mg/m^2 dose on Days 2-5; Cisplatin will be administered intravenously at a 25mg/m^2 dose on Days 2-5; and pedylated G-CSF 6mg will be administered subcutaneously on Day 6 or 7, or G-CSF as defined in the protocol on Days 6-18. In Arm B, patients will receive 5 cycles of the TI-CE treatment regimen. In cycles 1-2, patients will receive Paclitaxel 200mg/m^2 intravenously over 3 hours on Day 1; Ifosfamide 2000mg/m^2 intravenously on Days 1-3; G-CSF 10 ug/kg subcutaneously on Day 4 or Day 6 (cycle 1) and on Day 4 or Day 5 (cycle 2); and leukapheresis every 14 days. In cycles 3-5, patients will receive Carboplatin daily on Days 1-3; Etopside 400mg/m^2 daily on Days 1-3; stem cell reinfusion on Day 5; and pegylated G-CSF 6mg subcutaneously or G-CSF at appproximately 5ug/kg daily on Days 5-15.