View Clinical Trial (Medical Research Study)
Assessing PSA Response in Low Dose Ketoconazole in Hormone Refractory Prostate Cancer Patients Who Have Failed at Least One Prior Systemic Chemotherapy Regimen
| City: |
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Sacramento |
| State: |
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California |
| Zip Code: |
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95817 |
| Conditions: |
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Prostate Cancer |
| Purpose: |
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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 yet been approved by the Food and Drug Administration for use in prostate
cancer. Ketoconazole has been used for many years at high doses for prostate cancer, and
this study will be to look at use of lower dose ketoconazole after someone has received
chemotherapy. Ketoconazole works by halting the production of steroids in your body,
including testosterone, and is thought to work directly on prostate cancer cells in
published lab studies.
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| Study Summary: |
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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 treatment. The hypothesis of the study is that HRPC patients who
have been previously treated with chemotherapy will demonstrate objective PSA response rates
to low dose ketoconazole, comparable to historical response rates reported in
chemotherapy-naïve patients. This is a single arm trial, with all participants given
ketoconazole 200mg TID, along with hydrocortisone given at 20mg in the morning, 10mg at
night daily. Each cycle will consist of 28 days. The subject's study participation will
continue until subject experiences disease progression, unacceptable toxicities, withdraws
consent for the study or dies.
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| Criteria: |
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Inclusion Criteria:
- 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 Criteria:
- 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.
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| NCT ID: |
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NCT00895310 |
| Primary Contact: |
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Principal Investigator
Primo N Lara Jr., MD
University of California, Davis Health System
Primo N Lara, MD
Phone: 916-734-3771
Email: primo.lara@ucdmc.ucdavis.edu
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| Backup Contact: |
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Email: ernest.lo@ucdmc.ucdavis.edu
Ernest Lo, MD
Phone: 916-734-7946
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| Location Contact: |
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Sacramento, California 95817
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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