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

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
• 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
• ALT or 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 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