Irinotecan and UFT/leucovorin in patients with advanced cancers

The combination of irinotecan and fluorouracil (5-FU) is synergistic when a pplied to human colon cancer cell lines in vitro and appears to be schedule -dependent: maximal activity occurs when irinotecan is administered prior t o 5-FU. In this phase I study, irinotecan is administered in combination wi th UFT and leucovorin in patients with advanced solid tumors. Irinotecan is given as a 90-minute intravenous infusion on day 1 followed by twice-daily UFT plus oral leucovorin on days 2 through 15, Cycles are repeated every 2 1 days. Five patients have been treated to date; four are evaluable for tox icity, Starting doses were irinotecan 200 mg/m(2)/day, UFT 200 mg/m2/day, a nd leucovorin 60 mg/day, Preliminary results indicate that irinotecan in co mbination with UFT plus leucovorin is well tolerated at the initial doses ( described in this article).