An Intergroup Randomized Phase II Study of Bevacizumab (NSC 704865) or Cetuximab (NSC 714692) in Combination With Gemcitabine and in Combination With Chemoradiation (Capecitabine and Radiation) in Patients With Completely-Resected Pancreatic Carcinoma
I. To describe the toxicity profile of cetuximab and bevacizumab when combined with
gemcitabine, before and after capecitabine plus radiation and during capecitabine plus
radiation in patients with completely-resected pancreatic carcinoma in the adjuvant setting.
II. To assess the safety profile of either cetuximab or bevacizumab plus gemcitabine in
patients with resected pancreatic cancer.
III. To obtain tissue specimens from resections of patients enrolled on study for
correlative studies and further evaluations.
I. To evaluate disease-free and overall survival for patients receiving either cetuximab or
bevacizumab in combination with gemcitabine before and after capecitabine plus radiation.
II. To assess the safety profile for patients receiving either capecitabine plus cetuximab
plus radiation, or capecitabine plus bevacizumab plus radiation.
III. To correlate changes in serum amphiregulin and TGF alpha to survival, DFS and rash for
patients receiving cetuximab.
IV. To determine the 2-year survival rate for patients receiving either cetuximab plus
gemcitabine before and after capecitabine plus cetuximab plus radiation, or bevacizumab plus
gemcitabine before and after capecitabine plus bevacizumab plus radiation.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
degree of prior resection of the pancreatic tumor (R0 vs R1). Patients are randomized to 1
of 2 treatment arms.
Arm I: Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks
1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3,
13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks
5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and
continuing for approximately 5½ weeks (25 fractions).
Arm II: Patients receive bevacizumab IV over 60-90 minutes on day 1 in weeks 1, 3, 5, 7, 9,
11, 13, 15, 17, 19, 21, and 23. Patients also receive gemcitabine hydrochloride and
capecitabine and undergo radiotherapy as in arm I.
In both arms, treatment continues in the absence of disease progression or unacceptable
After completion of study treatment, patients are followed periodically for up to 3 years.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicities graded according to the CTCAE version 3.0
Evaluated separately in each treatment arm.
Up to 23 weeks
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
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