This phase II trial studies the effects of omeprazole and cabazitaxel in treating patients with prostate cancer that grows and continues to spread despite the surgical removal of the testes or medical intervention to block androgen production (castration-resistant) while taking docetaxel. Omeprazole works to reduce the amount of acid the stomach produces. Chemotherapy drugs, such as cabazitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving omeprazole and cabazitaxel may delay the spread of the prostate cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT04337580.
Locations matching your search criteria
United States
North Carolina
Salisbury
WG Hefner VA Medical CenterStatus: Active
Contact: Michael Moses Goodman
Winston-Salem
Wake Forest University Health SciencesStatus: Active
Contact: Michael Moses Goodman
Phone: 336-716-4464
PRIMARY OBJECTIVE:
I. Obtain Response Evaluation Criteria in Solid Tumors (RECIST) overall response rate (ORR) of 29% by adding the fatty acid synthase (FASN) inhibitor, omeprazole to cabazitaxel.
SECONDARY OBJECTIVES:
I. Pharmacodynamics-demonstrate omeprazole in vivo FASN inhibition by carbon-11 acetate (11C-acetate) positron emission tomography (PET)/computed tomography (CT). (Only for patients treated at Wake Forest Baptist Comprehensive Care Center [WFBCCC] main campus)
II. Obtain a prostate specific antigen (PSA) response rate by adding the FASN inhibitor omeprazole to cabazitaxel regimen (Scher, Morris et al. 2016) (Only for patients treated at WFBCCC main campus).
III. Measure pain using the Patient Reported Outcomes Measurement Information System (PROMIS) at baseline, cycle 5, cycle 12, and every cycle thereafter. (Only for patients treated at WFBCCC main campus).
OUTLINE:
Patients receive omeprazole orally (PO) twice daily (BID) beginning on day 0. Within 10 days, patients also receive cabazitaxel intravenously (IV) on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo 11C-acetate PET/CT 4-10 days after starting omeprazole.
After completion of study treatment, patients are followed up for 30 days.
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorMichael Moses Goodman