This is an open-label, non-randomized Phase II study to evaluate immunochemotherapy in patients with R0 OR R1-resected pancreatic cancer.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Cetuximab: Loading dose of 400 mg/m2, followed by weekly doses of 250 mg/m2. Cetuximab will be administered once weekly for up to 6 months (treatment duration: 24 weeks) Gemcitabine: 1000 mg/m2 administered on days 1, 8, 15 Cycles will be repeated on day 29, up to 6 treatment cycles will be administered Mode of administration: Intravenous infusion
Interdisziplinäres Tumorzentrum (Comprehensive Cancer Center)
Fulda, Germany
Nationales Centrum für Tumorerkrankungen (NCT), Universitätsklinikum Heidelberg
Heidelberg, Germany
Klinik für Innere Medizin II, Klinikum der Universität Jena
Jena, Germany
disease free survival
Time frame: 18 months after registration
Overall survival
Quality of life
Incidence of Adverse Events
Time frame: 19 months since registration
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Allgemein-, Viszeral- und Thoraxchirurgie, Klinikum Kassel
Kassel, Germany
Abt. für Chirurgie, Universitätsklinikum Mannheim gGmbH
Mannheim, Germany
Klinikum Giessen und Marburg, Standort Marburg
Marburg, Germany
II Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, TU München
Munich, Germany
Klinik- und Poliklinik für Innere Medizin I, Klinikum der Universität Regensburg
Regensburg, Germany