Study of Pancreatic Enzyme Replacement on Completion of Adjuvant Chemotherapy for Resected Pancreatic Adenocarcinoma

NCT ID: NCT03469258

Last Updated: 2020-08-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-13
• Study Completion Date: 2019-10-01

Brief 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

Detailed Description

The FDA (the U.S. Food and Drug Administration) has approved Zenpep as a treatment option for PEI. 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.

In this research study, the investigators are studying whether Zenpep will improve the ability of patients to complete adjuvant treatment for their pancreatic cancer after surgery to remove their tumor. The investigators are also studying if Zenpep will have an effect on nutrition status and quality of life for pancreatic cancer patients after they have had surgery to remove their tumor.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Zenpep

• Pancrelipase (Zenpep) will be administered with every meal (breakfast, lunch, dinner) and snack(s), continuously.
• Participants will begin pancrelipase on the day of enrollment and continue therapy until 1 year after surgery per calendar date

Group Type: EXPERIMENTAL

Pancrelipase

Intervention Type: DRUG

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.

Interventions

Pancrelipase

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 Type: DRUG

Other Intervention Names

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

A James Moser

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arthur James Moser, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17-450

Identifier Type: -

Identifier Source: org_study_id