Multicenter Phase II-trial to Investigate Safety and Efficacy of an Adjuvant Therapy With Gemcitabine and Erbitux® in Patients With R0 or R1 Resected Pancreatic Cancer
The available data of the presented studies indicate a possible benefit from adjuvant
chemotherapy for patients with resected pancreatic cancer. The optimal therapy regimen has
yet to be determined.
Based on the experiences with cetuximab (Erbitux®)and gemcitabine in advanced pancreatic
cancer and with gemcitabine as adjuvant therapy, the aim of this study is to evaluate the
feasibility of the combined treatment of cetuximab and gemcitabine in patients with R0 or
R1-resectable pancreatic cancer and to evaluate if the disease free survival can be
increased by the addition of an EGFR-targeted therapy.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
disease free survival
18 months after registration
Thomas M Gress, Prof.Dr. med
Klinik für Gastroenterologie, Endokrinologie und Stoffwechsel, University of Marburg
Germany: Federal Institute for Drugs and Medical Devices