Phase I study of weekly docetaxel and cisplatin arterial infusion for recurrent head and neck cancer.

BACKGROUND We planned a phase I study of weekly arterial infusion of docetaxel and cisplatin via a superficial temporal artery for recurrent head and neck cancer to determine the optimal dose. METHODS The dose of cisplatin was fixed and the dose of docetaxel was escalated from 8 mg/m(2) , with an increase of 2 mg/m(2) per step, to identify the maximum tolerated dose (MTD). In total, 4 courses of weekly chemotherapy were administered. RESULTS Twelve patients were recruited to this trial. The MTD of docetaxel was 14 mg/m(2) . At this dose level, dose-limiting toxicity was observed in 2 of 3 patients. One patient experienced grade 3 leukopenia, while the other experienced grade 3 leukopenia. Myelosuppression was the dose-limiting toxicity for this regimen. CONCLUSION The recommended dose for weekly arterial infusion of docetaxel was identified as 12 mg/m(2) combined with weekly cisplatin at 40 mg/m(2) , with 4 courses of each.