Final analysis of a randomized phase II study of bevacizumab (B) and gemcitabine (G) plus cetuximab (C) or erlotinib (E) in patients (pts) with advanced pancreatic cancer (PC)

Abstract

4502 Background: Targeting several critical pathways may be more effective than single pathway blockade in a resistant cancer like PC. In preclinical PC models, combining EGFR + VEGF targeted agents is synergistic. Methods: We conducted a multicenter, randomized phase II trial of dual targeted therapy, GBC or GBE, in advanced PC pts who had: no prior therapy for metastatic disease, PS 0–2, measurable disease, no bleeding risk or duodenal invasion. Primary endpoint: response; 2 parallel, Simon 2-stage designs. Baseline correlatives: plasma VEGF, serum VEGFR2. All pts received G 1000 mg/m2 over 30’ days (D) 1, 8, 15 Q28D; B 10 mg/kg D 1, 15 Q28D. Pts, stratified by PS and site, were randomized to C 400 mg/m2 D1 then 250 mg/m2 Q7D, or E 150 mg D1–5, 8- 12, 15–26 Q28D. Results: 139 evaluable pts (GBC/GBE 68/71) enrolled at 16 sites 9/04–2/07. Pt characteristics: median age 63/63 (range 36–83/39–86); male 49%/70%; PS 0 35%/48%, 1 59%/46%, 2 6%/6%. Cycles: 343/373 (median 4/4; range 1–18/1–18). Grade 3/4 toxici...