Phase II study of doxifluridine in advanced squamous cell carcinoma of the head and neck.

We conducted a phase II trial with 5'-deoxy-5-fluoridine (doxifluridine) in advanced squamous cell carcinoma of the head and neck. The drug was given at the dose of 4 g/m2 daily X 5 every 3 weeks. Twenty eligible patients entered this trial, 12 being evaluable for response to doxifluridine. The majority of these patients received previous treatment for cancer. One complete and two partial remissions were observed (25%). Drug-induced toxicity consisted mainly of myelosuppression, mild nausea and vomiting, stomatitis and central nervous system side-effects. Other dosages or schedules for doxifluridine administration might be explored in poor-risk patients.