A Phase II Trial of Cetuximab, Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-metastatic Pancreatic Adenocarcinoma
This is an open-label, non-randomized, combination study of cetuximab, gemcitabine, 5-FU,
and external beam radiotherapy in patients with locally advanced, non-metastatic pancreatic
All patients will be assessed by history and physical examination including weight, vital
signs, and performance status within 14 days of initiation of therapy. Baseline hematologic
and biochemical profiles, including CBC with differential, alkaline phosphatase, bilirubin,
SGOT (AST), BUN, creatinine, and CA 19-9 will be completed within 14 days of initiation of
During cycle I (chemoradiation), gemcitabine (200 mg/m2) and cetuximab 400mg/m2 initial dose
followed by 250mg/m2 IV weekly will be given with continuous infusion 5-FU (200 mg/m2/day)
delivered 5 of every 7 days and concurrent external beam radiation therapy. Cetuximab,
gemcitabine and 5-FU will begin on the first week of external beam radiotherapy and will
continue throughout the course of external beam radiation therapy, and will be discontinued
following the conclusion of external beam radiation therapy. All patients will have a
central venous access device placed to facilitate chemotherapy administration.
During cycles 2 through 5 (chemotherapy), gemcitabine will be administered at a dose of 1000
mg/m2 over 30 minutes followed by cetuximab at a dose of 250mg/m2 over 30 minutes weekly for
3 weeks followed by one-week rest for four cycles.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess progression-free survival of patients with locally advanced pancreatic cancer who are treated with concurrent gemcitabine, 5-FU, cetuximab and external beam radiation therapy.
Venu Bathini, MD
University of Massachusetts, Worcester
United States: Institutional Review Board