A Phase 0 Study of High Dose Omeprazole in Patients With Pancreatic Cancer Planning to Undergo Surgical Therapy for Evaluating Changes of Biomarkers
University of Oklahoma
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.
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.
Eligibility
- Age range
- 18–100 years
- Sex
- All
- 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, havin…
Interventions
- DrugOmeprazole
Treatment will consist of Omeprazole 12-14 days prior to surgical therapy of pancreatectomy.
Location
- Stephenson Cancer CenterOklahoma City, Oklahoma