High Dose Omeprazole in Patients With Pancreatic Cancer

Study Overview
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Brief Summary
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The purpose of this study is to test the safety of high dose omeprazole and see what effects that it has on patients with exocrine pancreatic cancer.

Detailed Description
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During this study patients will receive treatment of omeprazole at the dose depending on group enrollment Group A will receive omeprazole 80 mg, twice a day for 14 days unless unacceptable toxicity Group B, will receive omeprazole 20 mg, once a day for 14 days Patients will receive treatment for 2 3 weeks during the study, and 2 months of follow up. Total accrual is anticipated to take 2 years.

Official Title
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A Phase 0 Study of High Dose Omeprazole in Patients With Pancreatic Cancer Planning to Undergo Surgical Therapy for Evaluating Changes of Biomarkers

Conditions
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Exocrine Pancreatic Cancer

Intervention / Treatment
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* Drug: Omeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed exocrine pancreatic cancer with pathology confirmed as adenocarcinoma Patient is a candidate for surgical resection of pancreatic cancer ≥ 18 years old at the time of informed consent ECOG Performance Status 0-2 Patients with or without neoadjuvant chemotherapy will be eligible Ability to provide written informed consent and HIPAA authorization Women of childbearing potential definition must have a negative pregnancy test within 14 days of registration. All women (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) are considered to have childbearing potential unless they meet one of the following criteria: Prior hysterectomy or bilateral oophorectomy; Has not had menses at any time in the preceding 24 consecutive months Adequate organ function for surgical therapy Exclusion Criteria: Patients with pancreatic malignant tumor histologically confirmed as neuroendocrine or any other type of malignancies Positive pregnancy test, pregnant, or breastfeeding Known hypersensitivity to any component of the formulation or substituted benzimidazoles Any other clinically significant laboratory abnormality that would compromise patient safety or the outcome of the study Any clinically significant and/or uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study Medical condition that might affect the absorption of study medications in the opinion of the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A (High Dose)<br>Omeprazole, 80 mg, PO, BID for 2 weeks prior to surgical therapy of pancreatectomy. All 30 subjects in Arm A to be enrolled prior to Arm B cohort enrollment. | Drug: Omeprazole<br>* Treatment will consist of Omeprazole 2 weeks prior to surgical therapy of pancreatectomy.<br>|
| Placebo Comparator: Arm B (Normal Dose)<br>Omeprazole, 20 mg, PO, QD for 2 weeks prior to surgical therapy of pancreatectomy. | Drug: Omeprazole<br>* Treatment will consist of Omeprazole 2 weeks prior to surgical therapy of pancreatectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion | Proportion of subjects receiving study treatment without adverse events that would significantly delay the surgery | 2 years | 
| Safety and Tolerability | Frequency and severity of treatment related adverse events per CTCAE v5 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| v-ATPase LC3-I and LC3-II expression | v-ATPase LC3-I and LC3-II expression on pancreatic tumor | 2 years | 
| pH | pH of tumor tissue | 2 years | 
| Correlation | Correlation of biomarker changes with potential cancer cell apoptosis | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic cancer, omeprazole