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

A Phase II Study of Pancreatic Enzyme Replacement (Zenpep) on Completion Rates of Adjuvant Chemotherapy Among Subjects With Resected Pancreatic Ductal Adenocarcinoma

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

Study Overview

• Status: Terminated
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: Pancrelipase

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Drug: 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.; Other Names: Zenpep

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Pancreatic Enzyme Replacement Therapy on the Completion Rate of Adjuvant Chemotherapy and Radiation After Surgery for Early Stage Pancreatic Cancer	Completion, or not, of all doses of chemotherapy and fractions of radiation prescribed by the treating oncologist prior to the start of adjuvant treatment	40 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initiation Rate of Adjuvant Treatment for Resected Pancreatic Cancer	Percentage of subjects with resected pancreatic cancer starting adjuvant treatment by postoperative day 84	84 days after surgery
Subject Adherence to Pancreatic Enzyme Replacement Therapy as Determined by Pill Count	Pill count performed by study staff to be compared to subject meal and pill diary to determine percent adherence to prescribed regimen	52 weeks
Subject Adherence to Pancreatic Enzyme Replacement Therapy During Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer	Pill count performed by study staff will be compared to subject meal and pill diary to determine percent adherence to prescribed regimen	52 weeks
Measure Serum Albumin Levels Before and After Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer	Quantify serum albumin (g/dl ) to correlate pancreatic enzyme replacement therapy with nutrition status before and after surgery and adjuvant therapy for early stage pancreatic cancer	52 weeks
Measure Body Weight Before and After Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer	Measure body weight (in kg) at regular intervals throughout study participation to investigate whether pancreatic enzyme replacement therapy improves nutrition status during surgery and adjuvant treatment for early stage pancreatic cancer	52 weeks
Evaluate Quality of Life Before and After Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer Using the EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L) Questionnaire	Subjects to complete EQ-5D-5L at regular intervals throughout study participation. The scale consists of 5 questions, one each to assess mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each question has answers ranging from No Problems (level 1) to Extreme Problems (level 5). Subjects also to rate their overall health on a given day using the EuroQoL Visual Analog Scale (EQ-VAS) as a part of the EQ-5D-5L, which consists of marking on a visual scale from 0-100 (with 100 being best imaginable health and 0 being worst health imaginable).	52 weeks
Monitor the Incidence and Severity of Complications After Surgery for Early Stage Pancreatic Cancer	Incidence and severity of postoperative complications graded by Clavien-Dindo classification	84 days after surgery
Measure Grip Strength Before and After Surgery and Adjuvant Treatment for Early-stage Pancreatic Cancer	Standard grip strength dynamometer measurements at regular intervals throughout the study	52 weeks

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Allergan
• Investigators: Principal Investigator: Arthur James Moser, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 13, 2018
• Primary Completion (ACTUAL): October 1, 2019
• Study Completion (ACTUAL): October 1, 2019

Study Registration Dates

• First Submitted: February 15, 2018
• First Submitted That Met QC Criteria: March 12, 2018
• First Posted (ACTUAL): March 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Pancreatic Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Adenocarcinoma; Pancreatic Neoplasms; Gastrointestinal Agents; Pancrelipase; Pancreatin
• Other Study ID Numbers: 17-450

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No