Bevacizumab or Cetuximab And Gemcitabine Hydrochloride, Capecitabine, and Radiation Therapy in Treating Patients With Pacreatic Cancer That Has Been Completely Removed By Surgery
Stage IA Pancreatic Cancer, Stage IB Pancreatic Cancer, Stage IIA Pancreatic Cancer
About this trial
This is an interventional treatment trial for Stage IA Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria: Patients must have histologically or cytologically confirmed evidence of pancreatic carcinoma Patients must have had all gross disease resected (R0 or R1 resection) Patients undergoing an R2 resection are not eligible Patients must have had no prior chemotherapy or radiation therapy for pancreatic cancer and must have had no prior EGFR/VEGF inhibition Patient must have ECOG performance status of 0-2 Leukocytes >= 3,000/μL ANC >= 1,500/μL Platelets >= 100,000/μL Total bilirubin Within normal institutional limits AST (SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal Creatinine clearance >= 60 mL/min for patients with creatinine levels above institutional normal Patients must be > 4 weeks and =< 8 weeks post-surgery at time of study registration (may be up to 10 weeks post-surgery prior to start of study therapy) Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception prior to study entry Women must not be pregnant or breast-feeding; all agents used in this study as well as radiation therapy to the abdomen have the potential for teratogenic or abortifacient effects; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy Patients must not be receiving any other investigational agents Patients with known metastases are not eligible Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to cetuximab, bevacizumab or other agents used in the study are not eligible Patients with wounds that have not fully healed are not eligible Patients must not have cardiac arrhythmia Patients must have no known HIV infection Patients must not have any of the following: acinar cell carcinoma, neuroendocrine carcinoma, cystadenocarcinoma, carcinosarcoma Patients with psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude them from meeting the study requirements are not eligible Patients requiring full dose anticoagulation are not eligible Patients with a history of transient ischemic attack (TIA) or cerebrovascular accident (CVA) are not eligible Patients with a history of the following within twelve months of study entry are not eligible: Arterial thrombembolic events Unstable angina Myocardial infarction
Sites / Locations
- Eastern Cooperative Oncology Group
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (cetuximab, gemcitabine, capecitabine, radiation)
Arm II (bevacizumab, gemcitabine, capecitabine, radiation)
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).
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.