Effect of Oral Ketoconazole on the Pharmacokinetics of Oral Dexamethasone and Oral Hydrocortisone in Patients With Androgen Independent Prostate Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Primary Endpoint
- Pharmacokinetics of oral dexamethasone with and without oral ketoconazole
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Confirmed diagnosis of prostate cancer
- •Must have failed standard androgen-deprivation therapy
- •Evidence of rising PSA
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Creatinine ≤ 2.0 mg/dL
- •AST and ALT < 4 times upper limit of normal
- •Bilirubin < 2.0 mg/dL
- •No active congestive heart failure
- •No allergy to ketoconazole, dexamethasone, hydrocortisone, or to one of the components of dexamethasone, hydrocortisone, or ketoconazole
- •No active infection
- •No uncontrolled glaucoma
- •No active peptic ulcer disease
- •No uncontrolled diabetes mellitus
- •Fertile patients must use effective contraception during and for 3 months after completion of study therapy
- •PRIOR CONCURRENT THERAPY:
- •More than 2 weeks since prior and no concurrent drugs known to interact with study treatment
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Pharmacokinetics of oral dexamethasone with and without oral ketoconazole
Pharmacokinetics of oral hydrocortisone with and without oral ketoconazole
Secondary Outcomes
No secondary outcomes reported