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Omeprazole and Cabazitaxel for the Treatment of Docetaxel- and Castration- Resistant Prostate Cancer

Trial Status: Active

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.

Inclusion Criteria

  • Patients must have castrate refractory prostate cancer with prior docetaxel treatment which was used in the castrate refractory setting
  • Cancer progression as defined by Prostate Cancer Working Group 3 (PCWG3), any type- PSA only, bone only +nodal, nodal only, visceral, or new lesions
  • Age 18 or older
  • Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2
  • Life expectancy of greater than 2 months
  • Men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
  • Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document (either directly or via a legally authorized representative)
  • Absolute neutrophil count >= 1,200/mcL
  • Platelets >= 75,000/mcL
  • Total bilirubin = within normal institutional limits
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 X institutional upper limit of normal
  • Creatinine < 2.5 X institutional upper limit of normal

Exclusion Criteria

  • Patients may not be receiving any other investigational agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to omeprazole or taxane therapy
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

North Carolina

Winston-Salem
Wake Forest University Health Sciences
Status: 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 at baseline day 0 and 4-10 days after starting omeprazole.

After completion of study treatment, patients are followed up for 30 days.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Wake Forest University Health Sciences

Principal Investigator
Michael Moses Goodman

  • Primary ID WFBCCC85220
  • Secondary IDs NCI-2021-00696, IRB00068039
  • Clinicaltrials.gov ID NCT04337580