Advanced colorectal carcinoma

3655 Background: The purpose of this study was to compare the activity and toxicity of a CPT-11, LV, 5-FU combination with a standard regimen of 5-FU and low dose LV. Methods: One hundred and twelve patients, all with measurable disease and previously untreated with chemotherapy for advanced disease, have been randomized so far; 55 patients (group A) received LV 20mg/m2 i.i. bolus and 5-FU 425 mg/m2 i.i. bolus in days 1–5, with cycles repeated every 28 days. 57 patients (Group Â) received CPT-11 80mg/m2 (30–90min i.i. infusion), followed by LV 20mg/m2 i.i. bolus and 5-FU 425mg/m2 i.i. bolus in days 1, 8, 15, 22, 29, and 36, with cycles repeated every 8 weeks. Response was assessed every 3 months or when clinically indicated. The primary end point of this study was the overall objective tumor response rate (CR and PR). The study was designed principally to determine whether CPT-11, LV and 5-FU was a least as active as 5-FU/LV in the induction of tumor responses. A sample size of 302 patients per treatment ...