Ganitumab and Gemcitabine Hydrochloride Followed by Radiation Therapy, Ganitumab, Capecitabine, and Maintenance Therapy in Treating Patients With Locally Advanced Cancer of the Pancreas

You may be eligible if

• DISEASE CHARACTERISTICS:
• Pathologically confirmed (histologic or cytologic) locally advanced adenocarcinoma of the pancreas
• * Patients must have unresectable disease based on institutional standardized criteria of unresectability or medical inoperability
• Patients with or without regional adenopathy are eligible
• No distant metastases based upon the following minimum diagnostic workup:
• * History and/or physical examination, including collection of weight and vital signs, within 28 days prior to study entry
• * Abdominal and/or pelvic CT scan with IV contrast or MRI scan within 21 days prior to study entry
• * Chest CT scan or whole-body PET/CT within 21 days prior to study entry
• No second malignancy or peritoneal seeding
• PATIENT CHARACTERISTICS:
• Zubrod performance status 0-1
• Absolute neutrophil count (ANC) ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin (Hgb) ≥ 10.0 g/dL (the use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dL is acceptable)
• Glycosylated hemoglobin (HgbA1c) ≤ 8%
• Serum creatinine ≤ 1.5 mg/dL
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 3 times upper limit of normal (ULN)
• Total bilirubin \< 3.0 mg/dL
• Alkaline phosphatase \< 3 times ULN
• Fasting blood glucose \< 160 mg/dL
• * Patients with a non-fasting blood glucose \> 160 mg/dL (8.9 mmol/L) must have a fasting blood glucose ≤ 160 mg/dL (8.9 mmol/L) in order to be eligible
• No grade 2 or worse hearing impairment
• Negative serum pregnancy test (if applicable)
• Women of childbearing potential and men who are sexually active must be willing/able to use medically acceptable forms of contraception during the course of the study, and for 3 months (6 months for men) after the last study drug administration
• Not pregnant or nursing
• Ability to swallow oral medications
• At least 3 years since prior malignancy except non-melanomatous skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
• No severe active co-morbidity, defined as any of the following:
• * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
• * Transmural myocardial infarction within 6 months prior to study entry
• * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization, or precluding study therapy within 30 days before registration
• * 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
• * Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition
• * HIV testing is not required for entry into this protocol
• * Existing venous thromboembolism requiring anti-coagulation therapy
• No prior allergic reaction to capecitabine or gemcitabine hydrochloride
• PRIOR CONCURRENT THERAPY:
• No prior systemic chemotherapy for pancreatic cancer
• * Prior chemotherapy for malignancies other than pancreatic cancer is allowed provided chemotherapy was completed \> 3 years prior to study entry
• No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
• More than 28 days since any prior major surgery
• * Insertion of a vascular access device, insertion of a biliary stent, exploratory laparotomy, or laparoscopy are not considered major surgery
• No prior ganitumab
• Patients requiring concurrent oral anticoagulants (e.g., Coumadin, warfarin) are eligible provided there is increased vigilance with respect to monitoring international normalized ratio (INR)
• No concurrent participation in another clinical treatment trial
• No concurrent intensity-modulated radiotherapy
• No other concurrent therapy including the following:
• * Other investigational or approved chemotherapeutic agents
• * Other monoclonal antibody
• * Sorivudine or brivudine A
• * Cimetidine
• * G-CSF agents