High Dose Omeprazole in Patients With Pancreatic Cancer
- Registration Number
- NCT04930991
- Lead Sponsor
- University of Oklahoma
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A (High Dose) Omeprazole 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. Arm B (Normal Dose) Omeprazole Omeprazole, 20 mg, PO, QD for 12-14 days prior to surgical therapy of pancreatectomy.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method v-ATPase LC3-I and LC3-II expression 2 years v-ATPase LC3-I and LC3-II expression on pancreatic tumor
Correlation 2 years Correlation of biomarker changes with potential cancer cell apoptosis
pH 2 years pH of tumor tissue
Trial Locations
- Locations (1)
Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States