Status:
COMPLETED
Use of Low Dose Ketoconazole in Prostate Cancer That Does Not Respond to Hormone Therapy and Prior Chemotherapy
Lead Sponsor:
University of California, Davis
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test the safety of ketoconazole and how well it works after chemotherapy has been used. Ketoconazole at lower doses has been used for fungal infections however has not ...
Detailed Description
The aim of the study is to research the response of low dose ketoconazole in hormone refractory prostate cancer (HRPC) patients who have already undergone chemotherapy as part of their prostate cancer...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically proven prostate cancer with a Gleason score available or interpretable.
- Patients must have prostate cancer deemed to be hormone refractory, by progression of measurable or evaluable disease or rising PSA.
- Patients must be \>18 years old
- Patients must have received at least one prior chemotherapy regimen \>3 weeks prior to initiation of study and patients must have recovered from the side effects of the therapy
- Patients must have an ECOG status of 0-3
- Patients must have normal organ and marrow function, determined within 14 days of registration.
- Patients must have been surgically or medically castrated. If the method of castration was LHRH agonists (leuprolide or goserelin), then the patient must be willing to continue the use of LHRH agonists.
- Patients must have a serum total testosterone level \<50 ng/dl
- If the patient has been treated with non-steroidal anti-androgens (flutamide, bicalutamide or nilutamide) or other hormonal treatment (megace or steroids), the patient must have stopped these agents at least 28 days prior to enrollment for flutamide, megace or steroids and at least 42 days prior to enrollment for bicalutamide or nilutamide; and the patients must have demonstrated progression of disease since the agents were suspended.
Exclusion
- Patients with any condition that impairs the ability to swallow medications orally
- Patients who are unable to give informed consent
- Patients who have received ketoconazole treatment for prostate cancer in the past
- Patients with other active malignancies in the past 3 years except nonmelanoma skin cancer
- Patients may not be receiving any other investigational agents
- Patients with known hypersensitivity to ketoconazole
- Patients may not be taking certain medications, including terbinafine, astemizole, triazolam, statins (except pravastatin and fluvastatin) and acid suppressive agents (antacids, H2 blockers, PPI) while on ketoconazole, and patients on these medications must agree to discontinue these medications and consider alternative therapies.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00895310
Start Date
May 1 2009
End Date
May 1 2015
Last Update
March 30 2017
Active Locations (1)
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1
University of California, Davis Cancer Center
Sacramento, California, United States, 95817