Clinical trial NCT03469258: Study of Pancreatic Enzyme Replacement on Completion of Adjuvant Chemotherapy for Resected Pancreatic Adenocarcinoma
Official title: A Phase II Study of Pancreatic Enzyme Replacement (Zenpep) on Completion Rates of Adjuvant Chemotherapy Among Subjects With Resected Pancreatic Ductal Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: Pancreatic Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2018-03-19
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Effect of Pancreatic Enzyme Replacement Therapy on the Completion Rate of Adjuvant Chemotherapy and Radiation After Surgery for Early Stage Pancreatic Cancer
timeFrame: 40 weeks
Secondary outcomes:
measure: Initiation Rate of Adjuvant Treatment for Resected Pancreatic Cancer
timeFrame: 84 days after surgery
measure: Subject Adherence to Pancreatic Enzyme Replacement Therapy as Determined by Pill Count
timeFrame: 52 weeks
measure: Subject Adherence to Pancreatic Enzyme Replacement Therapy During Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer
timeFrame: 52 weeks
measure: Measure Serum Albumin Levels Before and After Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer
timeFrame: 52 weeks
measure: Measure Body Weight Before and After Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer
timeFrame: 52 weeks
measure: 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
timeFrame: 52 weeks
measure: Monitor the Incidence and Severity of Complications After Surgery for Early Stage Pancreatic Cancer
timeFrame: 84 days after surgery
measure: Measure Grip Strength Before and After Surgery and Adjuvant Treatment for Early-stage Pancreatic Cancer
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Arthur James Moser, MD
role: PRINCIPAL_INVESTIGATOR
References: