[Clinical phase II study of TK-117 by Cooperative Study Group. Effects on gastric cancer]

A clinical phase II study of TK-117, one of the derivatives of FUDR, was performed in 18 patients with gastric cancer by our Cooperative Study Group of Cancer Chemotherapy. Fourteen cases were evaluable and 3 of these showed partial response, giving a response rate of 21.4%. Toxic manifestations were experienced in fifteen of 18 cases (83.3%). Gastrointestinal toxicity was major and severe, especially diarrhea, which impeded the continuation of administration. This study revealed the usefulness of TK-117 for gastric cancer, but also the necessity of overcoming its toxicity, especially gastrointestinal complications.