A prospective, non-randomized phase II trial of Trastuzumab and Capecitabine in patients with HER2 expressing metastasized pancreatic cancer

摘要: Pancreatic cancer is the fourth most common cause of related death in Western countries. Advantages surgical techniques, radiation and chemotherapy had almost no impact on long term survival affected patients. Therefore, need for better treatment strategies urgent. HER2, a receptor tyrosine kinase EGFR family, involved signal transduction pathways leading to cell growth differentiation overexpressed number cancers, including breast pancreatic cancer. While HER2 has already been successfully used as target, there are only limited data evaluating effects inhibiting kinases patients with Here we report design prospective, non-randomized multi-centered Phase II clinical study Fluoropyrimidine-carbamate Capecitabine (Xeloda ®) monoclonal anti-HER2 antibody Trastuzumab (Herceptin®) non-resectable, overexpressing Patients eligible will receive infusions day 1, 8 15 concomitant oral intake from 1 14 each three week cylce. Cycles be repeated until tumor progression. A total 37 enrolled an interim analysis after 23 Primary end point determine progression free 12 weeks bimodal chemotherapeutic agent Trastuzumab. Secondary points include patient's survival, toxicity analysis, quality life, correlation overexpression response and, finally, CA19-9 plasma levels intervals.