Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency

Inclusion criteria

• Borderline resectable, locally advanced, and advanced pancreatic cancer patients (can include new or recurrent diagnosis) referred to SOCCI-CSMC (Samuel Oschin Cancer Center - Cedars Sinai Medical Center)
• Age ≥ 18 years.
• ECOG performance status 0-1 or Karnofsky PS >60%
• Clinical diagnosis of exocrine pancreatic insufficiency
• Cachexia defined as at least 5% weight loss in the presence of chronic illness, within any 6-month period prior to screening OR as documented by the medical physician based on standard diagnosis of cachexia
• Life expectancy of greater than 3 months, in the opinion of the investigator.
• Patients must have normal organ and marrow function as defined below:

• Absolute Neutrophil Count (ANC) ≥ 500/mcL
• Platelets ≥ 50,000/mcL
• Total bilirubin ≤ 5X upper limit of normal (ULN)
• AST(SGOT)/ALT(SGPT) ≤ 5 X ULN
• Creatinine OR creatinine clearance ≤ 3 times the upper limit of normal OR ≥ 30 mL/min/1.73 m² for patients with creatinine levels above normal.
• Note: Patients with biliary stents are eligible provided that all other inclusion criteria are met.
• Woman of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of signing the informed consent form, for the duration of study participation, and for at least 30 days after discontinuing from study treatment.
• Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Women who are pregnant or are breastfeeding
• Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
• Unable to swallow intact capsules
• Fibrosing colonopathy: Patients with history of fibrosing colonopathy have been reported to experience advancement to colonic strictures with doses of lipase>6000 units/kg/meal over prolonged periods of time.
• History of chronic illness associated with malabsorption or nutrient deficiency including but not limited to chronic pancreatitis, cystic fibrosis, celiac disease, Crohn's disease, pernicious anemia and/or prior intestinal resection.
• Coexistent other primary malignancy
• Pregnancy, breastfeeding, or of childbearing potential and not willing to use methods of birth control during the study
• Active drug abuse or intoxication with any substance including alcohol (blood alcohol content >0.08%, legal driving limit)
• Known allergy to any of the active ingredients in pancreatic enzyme supplementation
• Concurrent use of pancreatic enzyme supplementation or over the counter supplements which contain lipase, protease, and amylase as active ingredients