Exocrine Pancreatic Cancer
Conditions
Keywords
pancreatic cancer, omeprazole
Brief summary
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
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.
Interventions
DRUGOmeprazole
Treatment will consist of Omeprazole 12-14 days prior to surgical therapy of pancreatectomy.
Sponsors
University of Oklahoma
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion | 2 years | Proportion of subjects receiving study treatment without adverse events that would significantly delay the surgery |
| Safety and Tolerability | 2 years | Frequency and severity of treatment related adverse events per CTCAE v5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| v-ATPase LC3-I and LC3-II expression | 2 years | v-ATPase LC3-I and LC3-II expression on pancreatic tumor |
| pH | 2 years | pH of tumor tissue |
| Correlation | 2 years | Correlation of biomarker changes with potential cancer cell apoptosis |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAjay Jain, MD
University of Oklahoma
Outcome results
None listed