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.
Papers 1
- Registry-listed results paperMulticenter phase II trial to investigate safety and efficacy of gemcitabine combined with cetuximab as adjuvant therap… DOI 10.1093/annonc/mdt270↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.