RECRUITINGEarly Phase 1INTERVENTIONAL
High Dose Omeprazole in Patients With Pancreatic Cancer
A Phase 0 Study of High Dose Omeprazole in Patients With Pancreatic Cancer Planning to Undergo Surgical Therapy for Evaluating Changes of Biomarkers
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form
- You should be able to carry out daily activities with 0 level of ability (ECOG 0)-2
- Patients with or without neoadjuvant chemotherapy will be eligible
- Ability to provide written willing to sign a consent form 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
Who Should NOT Join This Trial:
- Patients with pancreatic malignant tumor diagnosed by tissue sample (biopsy-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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Omeprazole
Treatment will consist of Omeprazole 12-14 days prior to surgical therapy of pancreatectomy.
Locations (1)
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States