A cooperative-phase II study of 5-FU tablet at a dose of 200 to 300 mg/day (b.i.d. or t.i.d) on 27 patients with bladder cancer was performed at Yokohama City University and other affiliated hospitals. The therapeutic responses were evaluated by Koyama-Saito's criteria in 24 out of 27 patients, and 3 PR, 2 MR, 16 NC and 3 PD were obtained. The overall response rate was 12.5% (3/24). All of the responders received 5-FU tablets at a daily dose of 300 mg. Side effects were found in 2 out of 26 patients (7.7%). These were slight gastrointestinal symptoms. These results suggest that 5-FU tablet is a useful drug for bladder cancer.