Study of Bevacizumab in Combination With 5-FU, Oxaliplatin and External Beam Radiation Followed by Gemcitabine and Bevacizumab for Locally Advanced Pancreatic Cancer
Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring EBRT, advanced pancreatic cancer
Eligibility Criteria
Inclusion Criteria: Histologically and radiologically confirmed locally advanced pancreatic ductal adenocarcinoma and have not received prior therapy Disease is measurable by CT scan Age >= to 18 years Life expectancy of 4 months or longer ANC >/= 1,500mm/cm3 Hemoglobin >/= 9g/dl Platelet count >/= 100,000/cm3 Total bilirubin </= 2 times control SGOT/SGPT </= 2.5 times upper limit of normal Serum creatinine < 2mg/dl No evidence of metastatic disease by laparoscopy Exclusion Criteria: History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk for complications No secondary malignancies other than non-melanoma skin cancers or carcinoma in-situ of the cervix within past 5 years Patients with pre-existing peripheral neuropathy of grade 2 or greater Pregnant or lactating women Current, recent (within 4 weeks of study entry) or planned participation in an experimental drug study Blood pressure of >150/100 mmHg Unstable angina New York Heart Association Grade II or greater congestive heart failure History of myocardial infarction or stroke within 6 months Clinically significant peripheral vascular disease Evidence of bleeding diathesis or coagulopathy Presence of central nervous system or brain metastases Major surgical procedure, open biopsy,m or significant traumatic injury within 28 days prior to day 0 Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to day 0 Urine protein creatinine ratio > or = to 1.0 at screening History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 0 Serious, non-healing wound, ulcer, or bone fracture
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Regimen Level 1
Regimen Level 2
Radiation/Oxaliplatin/5-FU
Radiation/Oxaliplatin/Bevacizumab/5-FU