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A prospective study was carried out to determine the effectiveness and tolerance of ftorafur (2.25 g/m2 daily for 5 days, repeated every 4 weeks) in previously treated patients with advanced squamous cell cancers of the head and neck. Seventeen patients were entered in the study; 15 were evaluable for drug toxicity, and 14 were evaluable for response. Three patients had mild nausea, three had mild-to-moderate lethargy, two had nonspecific generalized weakness, and two had severe stomatitis. Of 15 patients three experienced leukopenia (causing death in one) and four had thrombocytopenia (life-threatening to one). Response to treatment included: progressive disease (nine patients), stable disease (four), and complete response (one with no previous radiotherapy or chemotherapy).