Effect of Oral Ketoconazole on the Pharmacokinetics of Oral Dexamethasone and Oral Hydrocortisone in Patients With Androgen Independent Prostate Cancer
OBJECTIVES:
- To evaluate the pharmacokinetics of oral dexamethasone with and without oral
ketoconazole in patients with androgen-independent prostate cancer.
- To compare the pharmacokinetics of oral hydrocortisone with and without oral
ketoconazole in these patients.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral dexamethasone twice daily on days 1-14, oral ketoconazole
3 times daily on days 2-14 and 30-42, and oral hydrocortisone twice daily on days
29-42.
- Arm II: Patients receive oral hydrocortisone twice daily on days 1-14, oral
ketoconazole 3 times daily on days 2-14 and 30-42, and oral dexamethasone twice daily
on days 29-42.
In both arms, patients may receive ketoconazole and hydrocortisone as standard salvage
therapy off study.
In both arms, patients undergo blood sample collection on days 1, 14, 29, and 42 for
pharmacokinetic studies.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Pharmacokinetics of oral dexamethasone with and without oral ketoconazole
No
Donald L. Trump, MD
Principal Investigator
Roswell Park Cancer Institute
Unspecified
I 93506
NCT00559481
October 2007
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