Ketoconazole, Dexamethasone, and Hydrocortisone in Treating Patients With Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy
RATIONALE: Studying samples of blood in the laboratory from patients with cancer receiving ketoconazole together with dexamethasone and hydrocortisone may help doctors learn more about how these drugs are used by the body.
PURPOSE: This randomized clinical trial is studying how ketoconazole, dexamethasone, and hydrocortisone act in the body of patients with prostate cancer that did not respond to androgen-deprivation therapy.
Drug: therapeutic hydrocortisone
Procedure: pharmacological study
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Oral Ketoconazole on the Pharmacokinetics of Oral Dexamethasone and Oral Hydrocortisone in Patients With Androgen Independent Prostate Cancer|
- Pharmacokinetics of oral dexamethasone with and without oral ketoconazole [ Designated as safety issue: No ]
- Pharmacokinetics of oral hydrocortisone with and without oral ketoconazole [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
- 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.
|Principal Investigator:||Donald L. Trump, MD||Roswell Park Cancer Institute|