Ketoconazole Plus Docetaxel to Treat Prostate Cancer
Status:
Completed
Trial end date:
2011-06-13
Target enrollment:
Participant gender:
Summary
This study will determine the maximum dose of docetaxel that can be given safely in
combination with ketoconazole for treating advanced prostate cancer. Docetaxel is approved
for the treatment of several other types of cancers; ketoconazole is an approved antifungal
medication that is also commonly used in high doses to treat prostate cancer.
Patients 18 years of age and older with advanced prostate cancer that does not respond to
hormone therapy may be eligible for this study. Candidates will be screened with blood tests
to evaluate liver, kidney and other organ function and with x-rays, scans, or other imaging
tests to determine the extent of disease.
Participants will take the following medications:
- Docetaxel daily, infused through a vein over 30 minutes, in 4-week cycles-3 consecutive
weeks of drug followed by one week of rest
- Dexamethasone, 12 hours and 1 hour before and 12 hours after docetaxel infusions to help
prevent fluid retention caused by the docetaxel
- Ketoconazole, 3 times a day
- Hydrocortisone, twice a day to replace a loss of natural steroids caused by the
ketoconazole
Patients will be hospitalized 1 to 2 days each for the first and second doses of docetaxel to
allow for frequent blood draws to measure blood levels of the drug. Ketoconazole will be
started about 2 weeks after the first dose of docetaxel and the second dose of docetaxel will
be given 2 days after that. In order to determine the maximum tolerated dose of docetaxel,
the first few patients in the study will be given a low dose of the drug, and subsequent
patients will get increasingly higher doses until unacceptable side effects occur. Because
prostate cancer cells may grow if exposed to testosterone, patients may have to have their
testosterone production suppressed either surgically (removal of the testicles) or medically
with an injection of leuprolide or goserelin, which are luteinizing hormone-release hormone
agonists that reduce the amount of testosterone.
Imaging studies, such as x-rays, bone scans or computed tomography (CT) scans, will be done
about every 3 months to examine how the tumor is responding to therapy. After six treatment
cycles, patients will have monthly chest x-rays to check for fluid around the lining of the
lungs, which may occur as a result of docetaxel therapy.
Treatment is expected to continue for at least 3 to 6 months, although this time could be
shortened or extended depending on the tumor response to therapy or side effects of the
drugs. Patients who do not experience bad side effects and whose tumor does not grow during
the first 3 treatment cycles will continue treatment; those who experience unacceptable side
effects will be taken off the study.
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