Ketoconazole, Dexamethasone, and Hydrocortisone in Treating Patients With Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Oral Ketoconazole on the Pharmacokinetics of Oral Dexamethasone and Oral Hydrocortisone in Patients With Androgen Independent Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: dexamethasone
* Drug: ketoconazole
* Drug: therapeutic hydrocortisone
* Procedure: pharmacological study


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: dexamethasone|nan|
|Drug: ketoconazole|nan|
|Drug: therapeutic hydrocortisone|nan|
|Procedure: pharmacological study|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of oral dexamethasone with and without oral ketoconazole |  |  | 
| Pharmacokinetics of oral hydrocortisone with and without oral ketoconazole |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent prostate cancer