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

Abstract

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/m2 with escalation at 2 mg/m2 per step. Results: Fifteen patients were enrolled in this trial. The maximal tolerated dose was 14 mg/m2, so the recommended dose was determined as 12 mg/m2. 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. © 2005 Foundation for Promotion of Cancer Research.