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Clinical Trial Record

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High Dose Omeprazole in Patients With Pancreatic Cancer

2021-09-07

2026-09

2027-09

60

Study Overview

High Dose Omeprazole in Patients With Pancreatic Cancer

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.

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 12-14 days unless unacceptable toxicity * Group B, will receive omeprazole 20 mg, once a day for 12-14 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.

  • Exocrine Pancreatic Cancer
  • DRUG: Omeprazole
  • OU-SCC-Omeprazole

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2021-03-29  

N/A  

2025-08-07  

2021-06-10  

N/A  

2025-08-11  

2021-06-18  

N/A  

2025-08  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Arm A (High Dose)

Omeprazole, 80 mg, PO, BID for 12-14 days prior to surgical therapy of pancreatectomy. All 30 subjects in Arm A to be enrolled prior to Arm B cohort enrollment.

DRUG: Omeprazole

  • Treatment will consist of Omeprazole 12-14 days prior to surgical therapy of pancreatectomy.
PLACEBO_COMPARATOR: Arm B (Normal Dose)

Omeprazole, 20 mg, PO, QD for 12-14 days prior to surgical therapy of pancreatectomy.

DRUG: Omeprazole

  • Treatment will consist of Omeprazole 12-14 days prior to surgical therapy of pancreatectomy.
Primary Outcome MeasuresMeasure DescriptionTime Frame
ProportionProportion of subjects receiving study treatment without adverse events that would significantly delay the surgery2 years
Safety and TolerabilityFrequency and severity of treatment related adverse events per CTCAE v52 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
v-ATPase LC3-I and LC3-II expressionv-ATPase LC3-I and LC3-II expression on pancreatic tumor2 years
pHpH of tumor tissue2 years
CorrelationCorrelation of biomarker changes with potential cancer cell apoptosis2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: SCC IIT Office

Phone Number: 405-271-8777

Email: SCC-IIT-Office@ouhsc.edu

Study Contact Backup

Name: Ingrid Block

Phone Number: 405-271-8777

Email:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:

  • Newly diagnosed exocrine pancreatic cancer with either pathology, histology, or radiology imaging documented 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
  • Candidate for surgery per standard of care of per surgeon's discretion

    • 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Ajay Jain, MD, University of Oklahoma

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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