A phase II trial of capecitabine (X) and irinotecan (I), in a biweekly schedule, for patients (Pts) with advanced/metastatic colorectal cancer (MCRC)

3683 Background: X and I are active in MCRC. The combination of these 2 agents has been shown to be synergistic. We conducted a phase II study of XI combination in a biweekly schedule in previously untreated pts with MCRC to evaluate the objective response rate (ORR), safety profile, time to progression (TTP) and overall survival (OS). Methods: Patients with histologically proven MCRC, measurable disease according to RECIST, ECOG PS ≤2 and adequate bone marrow, renal and hepatic functions were included. No prior chemotherapy (except adjuvant therapy) was allowed. Pts received I 175 mg/m2 iv D1 followed by oral X 1000 mg/m2 twice daily from D2–8. For patients >65 years, I and X were reduced to 140 mg/m2 and 750 mg/m2 twice daily, respectively. Cycles were repeated every 14 days. Toxicity was evaluated every cycle using NCI toxicity criteria. Results: 32 pts were enrolled to date: M/F, 22/10, median age was 68 years (49–80), 18 (56%) of pts were > 65 years, ECOG PS 0–1: 91%. Primary tumor sites were colon 4...