A phase II study of mitoxantrone in advanced squamous cell cancer of the head and neck.

Twenty patients with advanced squamous cell carcinomas (SCC) of the head and neck were entered into a phase II study of mitoxantrone at a dosage of either 12 mg/m2 or 14 mg/m2 given at 3 weekly intervals. None of the patients had received prior chemotherapy. One patient had a partial remission. Two patients died from unrelated causes. One patient withdrew from the trial prior to receiving any chemotherapy. Sixteen patients either failed to respond or progressed during the course of the treatment. Side effects included nausea and vomiting in 6 patients and neutropenia in 6 patients. This study failed to detect a significant response of squamous cell carcinomas of the head and neck to mitoxantrone therapy at the described doses.