Clinical trial NCT04098237: Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency
Official title: Pancreatic-enzyme Replacement Therapy With Pancreaze (Pancrelipase) Delayed-release in Addition to Standard of Care for Borderline Resectable, Locally Advanced, and Advanced Pancreatic Adenocarcinoma Patients (PANCAX-3) With Cachexia and Exocrine Pancreatic Insufficiency
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Pancreatic Adenocarcinoma
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: VIVUS LLC
First posted: 2019-09-23
Enrollment: 36
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: The objective of this study is to assess weight stability, functional changes, and quality of life when Pancreaze (pancrelipase) delayed-release 84,000-lipase units (capsules), for main meals, and 42,000-lipase units (capsules), for snacks, are added to standard of care in patients with exocrine pancreatic insufficiency due to pancreatic adenocarcinoma. This will be the first prospective study of this particular formulation in addition to standard of care in advanced pancreatic cancer patients. We will treat 40 consecutive patients with borderline resectable, locally advanced and advanced pancreatic cancer patients who present with weight loss and exocrine pancreatic insufficiency with this advanced formulation of Pancreaze.


Eligibility criteria: Inclusion Criteria:

1. Borderline resectable, locally advanced, and advanced pancreatic cancer patients (can include new or recurrent diagnosis) referred to SOCCI-CSMC (Samuel Oschin Cancer Center - Cedars Sinai Medical Center)
2. Age ≥ 18 years.
3. ECOG performance status 0-1 or Karnofsky PS \>60%
4. Clinical diagnosis of exocrine pancreatic insufficiency
5. Cachexia defined as at least 5% weight loss in the presence of chronic illness, within any 6-month period prior to screening OR as documented by the medical physician based on standard diagnosis of cachexia
6. Life expectancy of greater than 3 months, in the opinion of the investigator.
7. Patients must have normal organ and marrow function as defined below:

   * Absolute Neutrophil Count (ANC) ≥ 500/mcL
   * Platelets ≥ 50,000/mcL
   * Total bilirubin ≤ 5X upper limit of normal (ULN)
   * AST(SGOT)/ALT(SGPT) ≤ 5 X ULN
   * Creatinine OR creatinine clearance ≤ 3 times the upper limit of normal OR ≥ 30 mL/min/1.73 m² for patients with creatinine levels above normal.
   * Note: Patients with biliary stents are eligible provided that all other inclusion criteria are met.
8. Woman of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of signing the informed consent form, for the duration of study participation, and for at least 30 days after discontinuing from study treatment.
9. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
2. Women who are pregnant or are breastfeeding
3. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
4. Unable to swallow intact capsules
5. Fibrosing colonopathy: Patients with history of fibrosing colonopathy have been reported to experience advancement to colonic strictures with doses of lipase\>6000 units/kg/meal over prolonged periods of time.
6. History of chronic illness associated with malabsorption or nutrient deficiency including but not limited to chronic pancreatitis, cystic fibrosis, celiac disease, Crohn's disease, pernicious anemia and/or prior intestinal resection.
7. Coexistent other primary malignancy
8. Pregnancy, breastfeeding, or of childbearing potential and not willing to use methods of birth control during the study
9. Active drug abuse or intoxication with any substance including alcohol (blood alcohol content \>0.08%, legal driving limit)
10. Known allergy to any of the active ingredients in pancreatic enzyme supplementation
11. Concurrent use of pancreatic enzyme supplementation or over the counter supplements which contain lipase, protease, and amylase as active ingredients

Primary outcomes:
measure: Feasibility of Completing Pancreatic Enzyme Replacement Therapy During the First 8 Weeks of the Study: Daily Compliance Diary
timeFrame: 8 weeks
Secondary outcomes:
measure: Mean Change in Weight From Baseline Through the End-of-study Visit
timeFrame: 6 months
measure: Mean Change in Calories Consumed From Baseline Through the End-of-study Visit
timeFrame: 6 months
measure: Mean Change in Stool Frequency From Baseline Through Cycle 3 Day 1
timeFrame: 8 weeks
measure: Mean Change in Stool Consistency From Baseline Through Cycle 3 Day 1
timeFrame: 8 weeks
measure: Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin A
timeFrame: 6 months
measure: Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin D
timeFrame: 6 months
measure: Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin E
timeFrame: 6 months
measure: Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin K
timeFrame: 6 months
measure: Mean Change in Serum Levels of Fat-soluble Vitamins From Baseline - Vitamin K PT
timeFrame: 6 months
measure: Change in Microbiome From Baseline
timeFrame: 8 weeks
measure: Mean Change in Daily Activity (Steps Taken) From Baseline
timeFrame: 6 months
measure: Mean Change in Daily Activity (Stairs Climbed) From Baseline
timeFrame: 6 months
measure: Mean Change in Sleep Disturbance From Baseline
timeFrame: 6 months
measure: Mean Change in Duration of Sleep Disturbances From Baseline
timeFrame: 6 months
measure: Mean Change in Average Heart Rate From Baseline
timeFrame: 6 months
measure: Mean Change in Peak Heart Rate From Baseline
timeFrame: 6 months
measure: Mean Change in Daily Active Minutes From Baseline
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Andrew Hendifar, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: