A phase I study of combination chemotherapy with gemcitabine and oral UFT for advanced non-small cell lung cancer

Abstract

A phase I study was carried out to determine the optimal dose and administration schedule for combined UFT plus gemcitabine therapy in patients with non-small cell lung cancer. Twenty-four patients (including II patients previously treated with cispratin as the key drug) received oral UFT 400 mg m-2 on days 1 to 14 with intravenous infusions of gemcitabine (800 mg m-2 on days 8 and 15, or 900 mg m-2 on days 8 and 15, or 900 mg m-2 on days 1, 8 and 15). The most appropriate dosing option appeared to be 400 mg m-2 per day of oral UFT for 14 consecutive days with 900 mg m-2 gemcitabine on days 8 and 15. Eight of the 24 patients achieved partial response. The combination chemotherapy UFT and gemcitabine was well tolerated and may benefit patients with advanced non-small cell lung cancer. A multicentre phase II study using a 3-weekly regimen is in progress. © 2002 Cancer Research UK.