An Open, Randomized, Multicentre, Phase II Pilot Study

"Docetaxel (Taxotere) 75 mg/m² as a 1 hour i.v. infusion, followed immediately by cisplatin 75 mg/m² as a 1 hour i.v. infusion, on day 1 every 21 days for 6 cycles.~Dose reductions and/or treatment delays or discontinuation of treatment are planned for arm A in case of severe haematological and/or non haematological toxicities.~Premedication:~Dexamethasone 8 mg p.o. (or any other steroid commonly used) will be given -12 h, -3 h, -1 h before start of docetaxel infusion, then + 12 h, +24 h and + 36 h post infusion.~All patients should receive a prophylactic antiemetic premedication to prevent nausea and vomitus, which includes a 5-HT3 antagonist prior to start of each docetaxel infusion.~Hyperhydration Patients will require intravenous hydration according to institutional guidelines."