Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan in Treating Patients with Pancreatic Cancer That Has Spread to Other Places in the Body

Inclusion Criteria

• Subjects must have histologically or cytologically confirmed untreated metastatic pancreatic adenocarcinoma. Subjects with islet cell neoplasms are excluded. Subjects with mixed histology will be excluded
• Subject has one or more tumors measurable by computed tomography (CT) scan using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Magnetic resonance imaging (MRI) is acceptable if a CT scan is contraindicated.
• Male or non-pregnant and non-lactating female of age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status =< 1. ECOG 0 indicates that the patient is fully active and able to carry on all pre-disease activities without restriction; and, ECOG 1 indicates that the patient is restricted in physically strenuous activity but is ambulatory and able to carry out work of a light or sedentary nature
• Absolute neutrophil count >= 1,500/mcL
• Platelets >= 100 x 10^9/L
• Hemoglobin >= 8 g/dL
• Total bilirubin within normal institutional limits (=< 1.5 X upper limit of normal [ULN] if resolving biliary obstruction)
• Alkaline phosphatase =< 5 X ULN
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN (=< 5 X ULN for subjects with documented liver metastases)
• Creatinine within normal limits (creatinine clearance >= 60 mL/min/1.73 m^2 for subjects with creatinine levels above institutional normal)
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Patients who will be considered for surgery are ineligible
• Subjects who have had any prior chemotherapy for pancreatic cancer or prior chemotherapy within 5 years of enrollment for other cancer diagnoses
• Subjects who have had radiotherapy for pancreatic cancer
• Subjects who are receiving or have received any other investigational agents within 28 days prior to day 1 of treatment in this study
• Subject has undergone major surgery, other than diagnostic surgery (i.e. surgery done to obtain a biopsy for diagnosis or an aborted Whipple), within 28 days prior to day 1 of treatment in this study
• Subject has known brain metastases
• History of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, nab-paclitaxel, capecitabine, cisplatin, or irinotecan
• Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Subject has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the subject to receive an experimental research drug
• Subject has a known history of infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
• Subject is pregnant or breast feeding
• Subject is unwilling or unable to comply with study procedures
• Subject with clinically significant wound