Status:
TERMINATED
Study of Pancreatic Enzyme Replacement on Completion of Adjuvant Chemotherapy for Resected Pancreatic Adenocarcinoma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Allergan
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 pancr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03469258
Start Date
April 13 2018
End Date
October 1 2019
Last Update
August 3 2020
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115