Bevacizumab or Cetuximab And Gemcitabine Hydrochloride, Capecitabine, and Radiation Therapy in Treating Patients With Pacreatic Cancer That Has Been Completely Removed By Surgery
Condition: Stage IA Pancreatic Cancer; Stage IB Pancreatic Cancer; Stage IIA Pancreatic Cancer; Stage IIB Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: cetuximab; gemcitabine hydrochloride; capecitabine; radiation therapy; bevacizumab; laboratory biomarker analysis
Intervention description: Given IV; Given IV; Given orally; Undergo radiation therapy; Given IV; Correlative studies
Intervention MeSH terms: Bevacizumab; Antineoplastic Agents, Immunological; Cetuximab; Gemcitabine; Capecitabine; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 137.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial is studying bevacizumab to see how well it works compared to
      cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in
      treating patients with pancreatic cancer that has been completely removed by surgery.
      Monoclonal antibodies, such as bevacizumab and cetuximab, can block tumor growth in different
      ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
      help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the
      growth of tumor cells by blocking blood flow to the tumor. Cetuximab may also stop the growth
      of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in
      chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth
      of tumor cells, either by killing the cells or by stopping them from dividing. Radiation
      therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab or cetuximab together
      with gemcitabine, capecitabine, and radiation therapy after surgery may kill any tumor cells
      that remain after surgery. It is not yet known whether bevacizumab is more effective than
      cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in
      treating 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