Combination Chemotherapy With or Without Ganitumab in Treating Patients With Previously Untreated Metastatic Pancreatic Cancer

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed pancreatic ductal adenocarcinoma
• Metastatic disease to distant sites, as documented by CT scan or MRI
• Patients with locally advanced disease are NOT eligible
• At least one site of disease measurable by RECIST 1.1 criteria; defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 2 cm with conventional techniques or as ≥ 1 cm with spiral CT scan
• No known CNS metastases or carcinomatous meningitis, as determined by physical examination and/or imaging studies
• No suspected Gilbert syndrome or known homozygosity for the UGT1A1*28 allele (UGT1A1 genotyping is not required for enrollment on this study; however, patients known to be homozygous for the UGT1A1*28 allele are excluded)

PATIENT CHARACTERISTICS:

• ECOG performance status 0 or 1
• Neutrophils ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
• AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN
• INR ≤ 1.5
• Blood glucose level ≤ 160 mg/dL
• Patients with non-fasting blood glucose > 160 mg/dL must have a fasting blood glucose ≤ 160 mg/dL to be eligible
• Patients with diabetes mellitus are allowed at the discretion of the treating investigator, if blood sugars are felt to be under appropriate control
• Not pregnant or nursing
• Negative serum or urine pregnancy test
• No malignancy (other than non-melanoma skin cancer or carcinoma in situ of the cervix) diagnosed within the past 3 years or any currently active malignancy
• A malignancy is considered not "active" if all anti-cancer therapies were completed > 3 years before enrollment and there is no current evidence of persistent disease
• No neurosensory or neuromotor toxicity ≥ grade 2
• No known allergy to platinum compounds or E. coli-derived products (e.g., filgrastim, humulin, insulin, or L-asparaginase)
• No colonic or small bowel disorders with uncontrolled symptoms at baseline (for example, > 3 watery or soft stools daily in patients without colostomy or ileostomy)
• Patients with colostomy or ileostomy can be enrolled at the discretion of the investigator
• No history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within 6 months of registration
• No HIV-positive patients with a prior history of AIDS-defining illness
• No HIV-positive patients with a CD4 count of < 450 cells/mm³ at any point prior to study
• Anti-retroviral therapy must be discontinued during study treatment
• No known positivity for chronic infection with B virus (HBV)

PRIOR CONCURRENT THERAPY:

• Prior treatment with chemotherapy or radiotherapy for resected, locally advanced or metastatic pancreatic cancer is NOT allowed
• No prior treatment with inhibitors of the insulin-like growth factor 1 receptor
• No prior treatment with radiotherapy to greater than 25% of bone marrow
• Palliative radiation therapy may NOT be administered while a subject is on the study
• No major surgery within 4 weeks of the start of study treatment
• Patients must have recovered from the side effects of any major surgery at the start of study treatment
• Major surgery is defined as those surgeries that require general anesthesia
• Insertion of a vascular access device or endobiliary stent is NOT considered major surgery
• No percutaneous biliary drain (endobiliary stents are allowed)
• Warfarin for INR goal > 1.5 is prohibited
• Patients on warfarin with INR goal of ≤ 1.5 are eligible
• Hormones or other chemotherapeutic agents may NOT be administered except for steroids given for adrenal failure; hormones administered for non-disease-related conditions (e.g., insulin for diabetes); and intermittent use of dexamethasone as an antiemetic or for the prevention or treatment of ganitumab infusion reactions
• Patients receiving anti-retroviral therapy must discontinue such therapy while receiving study treatment