Pancrelipase in Treating Pancreatic Exocrine Insufficiency in Participants with Resected Pancreatic Cancer
This phase II trial studies how well pancrelipase works in treating pancreatic exocrine insufficiency in participants with pancreatic cancer that has been removed by surgery (resected). Pancreatic exocrine insufficiency is the inability to properly digest food due to a lack of digestive enzymes (proteins that speed up chemical reactions in the body) made by the pancreas organ. Pancrelipase may replace these enzymes when the body does not have enough of its own as a result of surgery and/or pancreatic cancer.
Inclusion Criteria
- STAGE I ENROLLMENT CRITERIA PRIOR TO SURGERY
- Participant must be a candidate for standard of care surgical resection of a mass suspected or proven to be pancreatic adenocarcinoma (PDAC) and its World Health Organization (WHO) variants
- A signed surgical consent to perform elective pancreatic resection is sufficient documentation of eligibility for standard of care surgical resection
- All standard of care pancreatic resections are eligible, including potential concurrent vascular resection and reconstruction with or without vein grafting
- Suspicious masses may be located anywhere within the pancreas
- Pathological confirmation of pancreatic adenocarcinoma (PDAC) is NOT required prior to enrollment if the resection specimen is the planned source tissue for confirmatory pathology
- Participants with prior biopsy or cytology confirmation of pancreatic adenocarcinoma are eligible
- Participant must be a candidate for standard of care adjuvant treatment according to their treating oncologist
- The anticipated treatment regimen and duration will be confirmed and recorded by study staff during the enrollment process
- Participants receiving preoperative/neoadjuvant chemotherapy and/or radiation therapy for pancreatic cancer are eligible if additional chemotherapy and/or radiotherapy is planned in the adjuvant setting. * Participants must not have completed more than half of the planned chemotherapy in the neoadjuvant setting
- Study staff shall confirm that potential participants are willing to consider adjuvant treatment after surgery. Participants who absolutely refuse to consider adjuvant treatment during the enrollment process are ineligible
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Participant must tolerate oral intake as their sole source of nutrition
- Hemoglobin > 7.0 g/dL
- Platelets >= 40,000/mL
- Creatinine < 2.5 mg/dL or; creatinine clearance >= 20 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal
- Ability to understand and willingness to provide written informed consent
- POSTOPERATIVE VISIT 1: VERIFICATION OF ELIGIBILITY
- Pancreatic resection performed
- ECOG performance status =< 2
- Able to tolerate oral intake as their sole source of nutrition
- Able to self-administer study drug **Note: Subjects who reside in Skilled Nursing Facilities or rehabilitation centers after surgery are not barred from participation so long as they are tolerating oral nutrition and can self-administer study drug provided to them by the SNF/rehab staff
- STAGE II ELIGIBILITY CRITERIA
- Final pathology must be pancreatic adenocarcinoma or WHO variants of PDAC or mixed histology if the predominant histology is adenocarcinoma
- Participant unwilling to take study drug or receive adjuvant therapy following surgical resection of disease, which equates to withdrawal of study consent for stage 2
Exclusion Criteria
- STAGE I EXCLUSION CRITERIA
- Any prior surgical resection , or attempted resection, of the pancreas for PDAC
- Surgical biopsies of the pancreas are permitted
- Any prior treatment for local recurrence or metastasis due to pancreatic adenocarcinoma (i.e. salvage chemo- or radiotherapy or re-resection for recurrence are not permitted)
- Participant unable to tolerate oral nutrition as the sole source of caloric intake at the time of enrollment, (i.e. no supplemental tube feeding or total parenteral nutrition)
- History of prior or concurrent malignancy, requiring treatment =< 3 years prior to enrollment. Exceptions: * Curatively treated non-melanoma skin cancer, cervical cancer in situ, or prostatic intraepithelial neoplasia, or prostate cancer that do not require ongoing treatment
- 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 adjuvant therapy required by this study to assess the primary endpoint is teratogenic. Pancrelipase is category C. Animal reproduction studies have not been conducted on pancrelipase, and minimal data is available
- 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 receiving any other investigational agents
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03469258.
PRIMARY OBJECTIVE:
I. To assess the effect of pancreatic enzyme replacement (pancrelipase [Zenpep]) therapy on the completion of standard of care adjuvant therapy among participants with resected pancreatic adenocarcinoma (PDAC).
SECONDARY OBJECTIVES:
I. To assess the effect of pancreatic enzyme replacement (Zenpep) therapy on the initiation rate of standard of care adjuvant therapy.
II. To assess subject adherence to pancreatic enzyme replacement therapy.
III. To evaluate the frequency of study-drug related dose modifications and severity of drug related adverse events during stage 1.
IV. To evaluate the incidence and severity of postoperative complications during stage 1.
V. To evaluate the effect of pancreatic enzyme replacement therapy on nutrition status during postoperative recovery and adjuvant treatment.
VI. To assess quality of life as measured by the European Quality of Life Five Dimension Five Level scale (EQ-5D-5L) during postoperative recovery and adjuvant treatment.
VII. To evaluate grip strength, nutritional status and Eastern Cooperative Oncology Group (ECOG) performance during postoperative recovery and adjuvant treatment.
OUTLINE:
Participants receive pancrelipase orally (PO) with every meal and snack. Treatment continues for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up for 52 weeks.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorArthur James Moser
- Primary ID17-450
- Secondary IDsNCI-2018-00779
- ClinicalTrials.gov IDNCT03469258