Study of Pancreatic Enzyme Replacement on Completion of Adjuvant Chemotherapy for Resected Pancreatic Adenocarcinoma
Condition: Pancreatic Cancer
MeSH terms: Adenocarcinoma; Pancreatic Neoplasms
Intervention: Pancrelipase
Intervention description: Zenpep is a combination of three enzymes (proteins). These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars. Zenpep is used to replace these enzymes when the body does not have enough of its own as a result of surgery and/or pancreatic cancer.
Intervention MeSH terms: Pancrelipase; Pancreatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreatic Cancer

Summary:

      This research study is evaluating a study drug to treat pancreatic exocrine insufficiency
      (PEI) during the first year after the diagnosis of pancreatic cancer while the participant is
      recovering from surgery and receiving adjuvant treatment.

      The study drug involved in this study is:

      -Zenpep
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have histologically or cytologically confirmed pancreatic ductal
             adenocarcinoma. Variants or mixed histology will be included if the predominant
             histology is adenocarcinoma.

          -  Participants must have potentially resectable pancreatic cancer defined as: (1) no
             detectable metastases (2) signed consent for attempted resection of pancreatic cancer
             per treating surgeon.

          -  ECOG performance status ≤2.

          -  Age >18 years. Participants <18 years old are excluded from this study because
             subsequent adjuvant therapy is based on therapy guidelines in the adult population.

          -  Willingness to consider adjuvant therapy following surgical resection of disease,
             signed in the consent form attestation.

          -  Ability to understand and willingness to provide written informed consent.

          -  Pre-operative laboratory values adequate to undergo resection of pancreatic cancer, as
             defined below:

               -  Hemoglobin > 7.0 g/dL;

               -  Platelets ≥ 40,000/mL;

               -  Creatinine < 2.5 mg/dL or; Creatinine clearance ≥ 20 mL/min/1.73 m2 for
                  participants with creatinine levels above institutional normal.

        Exclusion Criteria:

          -  Pancreatic resection not performed. Intraoperative findings and unforeseen medical
             exigent circumstances may preclude pancreatic resection. Such outcomes include
             undetected metastases or vascular involvement, which preclude resection with intent to
             cure, as well as perioperative medical events including cardiopulmonary complications.

          -  Final pathology other than pancreatic ductal adenocarcinoma or primary component other
             than adenocarcinoma.

          -  Any prior chemotherapy and/or radiation for pancreatic cancer at the time of study
             enrollment, including neoadjuvant chemotherapy and/or radiation therapy.

          -  Second malignancy with active disease.

          -  History of allergic reactions or hypersensitivity attributed to compounds of similar
             chemical or biologic composition to pancrelipase

          -  Pregnant women are excluded from this study because subsequent adjuvant therapy needed
             for the primary endpoint is teratogenic. Pancrelipase is category C. Animal
             reproduction studies have not been conducted on pancrelipase and minimal data is
             available.

          -  Participants unable to self-administer pancrelipase.

          -  Uncontrolled intercurrent illness including, but not limited to, symptomatic
             congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric
             illness/social situations that would limit compliance with study requirements.

          -  Participants who are receiving any other investigational agents.

          -  Participant unable to tolerate oral nutrition.