Pancreatic Cancer Research

Clinical trialPhase 2Completed

Safety and Efficacy Therapy of Gemcitabine and Erbitux® to R0 or R1 Resected Pancreatic Cancer

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

Outcome
Finished, no results posted
Phase
Phase 2
Status
Completed
Study type
Interventional
Start
October 2006
Expected end
January 2012
Enrollment
76 participants
Sites
8
Primary outcomes
disease free survival
Sponsor
Other
Results posted
No
Last update
2 October 2015

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Brief summary public domain (ClinicalTrials.gov)

This is an open-label, non-randomized Phase II study to evaluate immunochemotherapy in patients with R0 OR R1-resected pancreatic cancer.

Detailed description public domain (ClinicalTrials.gov)

Available study data indicated 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 was 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.