FOLFIRINOX With Digoxin in Patients With Resectable Pancreatic Cancer

Inclusion Criteria:

• Pathologically confirmed pancreatic adenocarcinoma. Participants must haveresectable disease with no evidence of distant metastasis.

• 19 years of age or older.

• Eastern Cooperative Oncology Group (ECOG) Performance Scale (PS) of 0-1 (fullyactive to restricted in strenuous activity).

• Chemotherapy for malignancies other than pancreatic cancer completed > 5 years agoand is no evidence of the prior malignancy at time of study entry.

• Radiographically assessable disease.

• Initial absolute neutrophil count (ANC) greater than or equal to 1000/μL andplatelet count greater than or equal to 100,000/μL.

• Normal serum potassium, magnesium and corrected calcium level.

• Serum creatinine less than or equal to 2.0 mg/dL.

• Total bilirubin <= 1.5 mg/dL [unless the participant has Gilbert disease withelevated non-conjugated (indirect) bilirubin; in such cases, the indirect bilirubinshould be <= 1.0 mg/dL].

• If participant has biliary obstruction, biliary decompression will be required.Either endoscopic placement of biliary stent or percutaneous transhepatic drainageare acceptable. Once biliary drainage has been established, institution of FOLFOXtherapy may proceed when the total bilirubin falls to <= 5.0 mg/dL. The addition ofirinotecan will be delayed until the total bilirubin is 1.5 mg/dL or lower.

• Awareness of the neoplastic nature of his/her disease and willingly provide written,informed consent after being informed of the procedure to be followed, theexperimental nature of the therapy, alternatives, potential benefits, side-effects,risks, and discomforts.

• No prior chemotherapy for pancreatic cancer.

Exclusion Criteria:

• Unable to undergo staging laparoscopy, such as a prior history of multiple abdominaloperations in which laparoscopy may not be technically feasible or might bepotentially harmful.

• A contra-indication to receiving digoxin therapy (e.g., AV block, sick sinussyndrome, bradycardia, hypersensitivity to digoxin or digitalis preparations).

• Uncontrolled inter-current illness including, but not limited to ongoing or activeinfection requiring intravenous antibiotics, symptomatic congestive heart failure,unstable angina pectoris, or serious, uncontrolled cardiac arrhythmia, that mightjeopardize the ability of the participant to receive the therapy in this study withreasonable safety.

• Pregnant and nursing women (risk posed by chemotherapy agents). Female participantsof childbearing potential must have a negative urine pregnancy test before receivingthe first dose of study drug.

• Prior malignancy except for adequately treated basal cell or squamous cell skincancer, adequately treated non-invasive carcinomas, or other cancers from which theparticipant has been disease-free least 5 years.

• Known HIV infection or active hepatitis B or C infection (concern for increasedtoxicity).

• Active autoimmune disease [e.g., rheumatoid arthritis (RA), systemic lupuserythematosus (SLE), ulcerative colitis (UC), Crohn's Disease, multiple sclerosis (MS), ankylosing spondylitis (AS)].

• Recognized acquired, hereditary, or congenital immunodeficiency disease includingcellular immunodeficienciess, hypogammaglobulinemia, or dysgammaglobulinemia.