Gemcitabine plus sorafenib in patients with advanced pancreatic cancer: a phase II trial of the University of Chicago Phase II Consortium

摘要: Background Sorafenib, an inhibitor of B-raf, VEGFR2, and PDGFR-β, has activity against pancreatic cancer in preclinical models. In a phase I trial gemcitabine plus sorafenib, 57% patients achieved stable disease. Patients methods We conducted multi-center II sorafenib chemo-naive with histologically-confirmed, advanced cancer. received 400 mg twice daily 1,000 mg/m2 on days 1, 8 15 28 day cycle. Results Seventeen enrolled at 4 centers; 13 were evaluable for response. There no objective responses; 18% had Median overall survival was 4.0 months (95% CI: 3.4, 5.9); median progression-free 3.2 1.6, 3.6). Grade 3/4 toxicities included thrombosis patients, dehydration or hand-foot syndrome 12%, hypertension gastrointestinal bleeding 6%. Conclusion Gemcitabine is inactive