Phase I trial of weekly docetaxel and concurrent radiotherapy for head and neck cancer in elderly patients or patients with complications

OBJECTIVE: We planned a phase I study of radiotherapy combined with weekly docetaxel for elderly patients or patients with complications to find out the optimal dose. METHODS: Five consecutive weekly administrations of docetaxel were accompanied by radiotherapy for patients diagnosed with squamous cell carcinoma of the head and neck. The starting dose of docetaxel was 10 mg/m(2) with escalation at 2 mg/m(2) per step. RESULTS: Fifteen patients were enrolled in this trial. The maximal tolerated dose was 14 mg/m(2), so the recommended dose was determined as 12 mg/m(2). Hematological toxicity was sufficiently weak. Common dose-limiting toxicity was stomatitis within the radiation field. CONCLUSIONS: This protocol was thought to be practical for elderly patients or those with medical complications.