High-Dose Omeprazole for the Treatment of Patients with Pancreatic Cancer before Surgery, OMEPRAZOLEPANC Trial

PRIMARY OBJECTIVES:

I. To evaluate the safety of high dose omeprazole in patients with newly diagnosed exocrine pancreatic cancer who are considered as candidate for surgical resection. (Safety lead-in cohort)

II. To determine the feasibility and safety of high dose omeprazole, comparing with the normal dose omeprazole, in patients with newly diagnosed exocrine pancreatic cancer who are considered as candidate for surgical resection. (Phase 0 study)

SECONDARY OBJECTIVES:

I. To evaluate the biomarker changes of vacuolar-ATPase (v-ATPase) LC3-I and LC3-II upon treatment with high dose omeprazole.

II. To evaluate the association of biomarker changes with pancreatic cancer cell apoptosis.

III. To compare level of v-ATPase LC3-I and LC3-II and pH value in tumor tissues collected from patients treated with high dose omeprazole (arm A) and normal dose omeprazole (arm B).

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM A: Patients receive high-dose omeprazole orally (PO) twice a day (BID) for 12-14 days prior to standard of care surgery in the absence of unacceptable toxicity. Additionally, patients undergo magnetic resonance imaging (MRI) or computed tomography (CT) scans during screening as well as pancreatectomy and tissue sample collection on study.

ARM B: Patients receive standard-dose omeprazole PO once daily (QD) for 12-14 days prior to standard of care surgery in the absence of unacceptable toxicity. Additionally, patients undergo MRI or CT scans during screening as well as pancreatectomy and tissue sample collection on study.

After completion of study treatment, patients are followed-up for 2 months.