Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03469258
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : March 7, 2019
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
A James Moser, Dana-Farber Cancer Institute

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


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Pancrelipase Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 67 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Phase II Study of Pancreatic Enzyme Replacement (Zenpep) on Completion Rates of Adjuvant Chemotherapy Among Subjects With Resected Pancreatic Ductal Adenocarcinoma
Actual Study Start Date : April 13, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


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 Name: Zenpep




Primary Outcome Measures :
  1. Effect of pancreatic enzyme replacement therapy on the completion rate of adjuvant chemotherapy and radiation after surgery for early stage pancreatic cancer [ Time Frame: 40 weeks ]
    Completion, or not, of all doses of chemotherapy and fractions of radiation prescribed by the treating oncologist prior to the start of adjuvant treatment


Secondary Outcome Measures :
  1. Initiation rate of adjuvant treatment for resected pancreatic cancer [ Time Frame: 84 days after surgery ]
    Percentage of subjects with resected pancreatic cancer starting adjuvant treatment by postoperative day 84

  2. Subject adherence to pancreatic enzyme replacement therapy as determined by pill count [ Time Frame: 52 weeks ]
    Pill count performed by study staff to be compared to subject meal and pill diary to determine percent adherence to prescribed regimen

  3. Subject adherence to pancreatic enzyme replacement therapy during surgery and adjuvant treatment for early stage pancreatic cancer [ Time Frame: 52 weeks ]
    Pill count performed by study staff will be compared to subject meal and pill diary to determine percent adherence to prescribed regimen

  4. Measure serum albumin levels before and after surgery and adjuvant treatment for early stage pancreatic cancer [ Time Frame: 52 weeks ]
    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

  5. Measure body weight before and after surgery and adjuvant treatment for early stage pancreatic cancer [ Time Frame: 52 weeks ]
    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

  6. 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 [ Time Frame: 52 weeks ]
    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).

  7. Monitor the incidence and severity of complications after surgery for early stage pancreatic cancer [ Time Frame: 84 days after surgery ]
    Incidence and severity of postoperative complications graded by Clavien-Dindo classification

  8. Measure grip strength before and after surgery and adjuvant treatment for early-stage pancreatic cancer [ Time Frame: 52 weeks ]
    Standard grip strength dynamometer measurements at regular intervals throughout the study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03469258


Contacts
Layout table for location contacts
Contact: AJ Moser, MD 617 632 1030 pancreas@bidmc.harvard.edu
Contact: Leanne Ianniello 617 975 7409 lianniel@bidmc.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: AJ Moser       pancreas@bidmc.harvard.edu   
Principal Investigator: Arthur James Moser, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Allergan
Investigators
Layout table for investigator information
Principal Investigator: Arthur James Moser, MD Beth Israel Deaconess Medical Center

Layout table for additonal information
Responsible Party: A James Moser, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03469258     History of Changes
Other Study ID Numbers: 17-450
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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

Keywords provided by A James Moser, Dana-Farber Cancer Institute:
Pancreatic Cancer

Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Adenocarcinoma
Carcinoma
Digestive System Diseases
Endocrine System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents