Phase II Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody C225 in Combination With Gemcitabine in Patients With Advanced Pancreatic Cancer
OBJECTIVES: I. Determine objective response, time to progression, survival, clinical benefit
response, and quality of life of patients with locally advanced, metastatic, or recurrent
adenocarcinoma of the pancreas when treated with cetuximab and gemcitabine. II. Determine
the safety and toxicity profile of this regimen in this patient population.
OUTLINE: This is a multicenter study. Patients receive a test dose of cetuximab IV over 10
minutes followed by a 30 minute observation period. Following observation, patients receive
a loading dose of cetuximab IV over 1-2 hours followed 1 hour later by gemcitabine IV over
30 minutes weekly for 7 weeks. Following 1 week of rest, patients with stable or responding
disease continue treatment for a maximum of 6 months. During subsequent courses, patients
receive maintenance doses of cetuximab IV over 1 hour weekly for 8 weeks. Gemcitabine IV is
administered over 30 minutes weekly for 3 weeks, followed by 1 week of rest, and then
repeated for a total treatment course of 8 weeks. Treatment continues in the absence of
unacceptable toxicity or disease progression. Quality of life is assessed at baseline, after
each course of therapy, and at 3 months after therapy. Patients are followed every 3 months
until evidence of disease progression.
PROJECTED ACCRUAL: A minimum of 40 patients will be accrued for this study within 8 months.
Primary Purpose: Treatment
Albert F. LoBuglio, MD
University of Alabama at Birmingham
United States: Federal Government