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

Inclusion Criteria

• •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