Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer
A Phase II Trial of FASN Inhibition by Omeprazole in Combination With Cabazitaxel in Patients With Docetaxel- and Castration-Resistant Prostate Cancer
About This Trial
- This study is testing whether combining a medication called omeprazole with standard chemotherapy drugs (docetaxel or cabazitaxel) can help the chemotherapy work better to fight cancer while tracking side effects.
- It is for adults with advanced prostate cancer that continues to grow or spread despite hormone therapy and prior treatment with docetaxel chemotherapy.
- Before considering this trial, you should know that you must be in reasonably good daily health with adequate organ function, and you cannot have active infections, severe heart issues, or allergies to the study drugs.
- Additionally, participants must agree to use reliable birth control during the study and for three months after treatment ends.
More Information
- The purpose of this research study is to find out what effects (good and bad) omeprazole and cabazitaxel, or omeprazole and docetaxel, has on participants and their condition.
- Investigators believe omeprazole may help the other medications work.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This study is testing whether combining a medication called omeprazole with standard chemotherapy drugs (docetaxel or cabazitaxel) can help the chemotherapy work better to fight cancer while tracking side effects.
Study Details
- Start Date: March 5, 2021
- Lead Sponsor: Wake Forest University Health Sciences
Full Eligibility Criteria
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- prostate specific antigen only, bone only +nodal, nodal only or new lesions
- Age 18 or older.
- 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 three (3) months after study treatment discontinuation.
- Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
- Organ & marrow function as defined below: Absolute neutrophil count >1,200/mcL, Platelets >75,000/mcL; total bilirubin = within normal institutional limits; AST(SGOT)/ALT(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.
Treatments
- Drug: Omeprazole 80 mg twice daily