Phase II study of bevacizumab (BEV), weekly (wkly) intermittent capecitabine (Cap), and oxaliplatin (Ox) on an every-2-week schedule for patients (Pts) with untreated advanced colorectal cancer (CRC)

4061 Background: CapOx and Bev is becoming a standard regimen for advanced CRC utilizing Cap on a d 1–14 schedule every 3 wks. However optimal doses and schedules of Cap with Ox and Bev needs continued evaluation. Intermittent wkly Cap (3,500 mg/m2, d 1–7) with Ox (85 mg/m2) every 2 wks compared to the standard CapOx regimen in untreated advanced CRC has shown superior response and progression free survival (PFS) in Europe (JCO 21,1307; 2003). Methods: This phase II trial was designed to evaluate weekly intermittent Cap with Ox and Bev (A-ICOX regimen) in US pts with CRC. The primary endpoint was to detect a 50% improvement in median PFS from 8 to 12 months. Study required 40 patients, with 81% power (1-sided level 0.1 log-rank test). Cap was initially administered at dose of 2,500 mg/m2 in two divided doses on d 1–7 (n=11) and was increased to 3,000 mg/m2 dose (n=29), based on tolerability of the lower dose. The dose of Ox was 85 mg/m2 and Bev 5 mg/kg. Cycles were repeated every 2 wks. Preliminary data r...