Conatumumab, Gemcitabine Hydrochloride, Capecitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed adenocarcinoma of the pancreas
• •* Locally advanced disease
• •* With and without regional adenopathy
• •Unresectable disease based on institutional standardized criteria of unresectability OR medically inoperable
• •No distant metastatic disease, second malignancy, or peritoneal seeding
• •PATIENT CHARACTERISTICS:
• •Zubrod performance status 0-1
• •Absolute granulocyte count ≥ 1,500/mm³
• •Platelet count ≥ 100,000/mm³
• •Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)
• •Serum creatinine ≤ 1.5 mg/dL
• •ALT or AST \< 3 times upper limit of normal (ULN)
• •Total bilirubin \< 3.0 mg/dL
• •Alkaline phosphatase \< 3 times ULN
• •Amylase ≤ 2 times ULN
• •Lipase ≤ 2 times ULN
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for ≥ 3 months after the last study drug administration (for women) or for ≥ 6 months after the last study drug administration (for men)
• •Able to swallow oral medications
• •No other invasive malignancy within the past 2 years, except for nonmelanomatous skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
• •No severe, active co-morbidity, including any of the following:
• •* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within the past 30 days
• •* Transmural myocardial infarction within the past 3 months
• •* Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
• •* Any other cardiac condition that, in the opinion of the treating physician, would make study treatment unreasonably hazardous for the patient
• •* Acute bacterial or fungal infection requiring IV antibiotics
• •* Uncontrolled malabsorption syndrome significantly affecting gastrointestinal function
• •* Any unresolved bowel or bile duct obstruction
• •* Major resection of the stomach or small bowel that could affect the absorption of capecitabine
• •* AIDS based upon current CDC definition
• •* HIV testing is not required for study entry
• •No prior allergic reaction to capecitabine or gemcitabine hydrochloride
• •PRIOR CONCURRENT THERAPY:
• •No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
• •No prior treatment with TRAIL-receptor agonists
• •No prior systemic chemotherapy for pancreatic cancer
• •More than 2 years since prior chemotherapy for malignancies other than pancreatic cancer
• •More than 28 days since prior major surgery (e.g., biliary or gastric bypass)
• •* Insertion of a vascular access device, exploratory laparotomy, or laparoscopy are not considered major surgery
• •No concurrent intensity-modulated radiotherapy
• •No other concurrent chemotherapy
• •No other concurrent monoclonal antibody therapy
• •No concurrent sorivudine, brivudine A, or cimetidine
• •No concurrent participation in another clinical trial
• •Concurrent oral anticoagulants (e.g., warfarin) allowed provided INR is monitored