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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label

Study Primary Completion Date: January 2010

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.

Intervention(s) in this Clinical Trial

• Drug: dexamethasone
• Drug: ketoconazole
• Drug: therapeutic hydrocortisone
• Procedure: pharmacological study

Primary Measures

• Pharmacokinetics of oral dexamethasone with and without oral ketoconazole
  • Safety Issue?: No
• Pharmacokinetics of oral hydrocortisone with and without oral ketoconazole
  • Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Roswell Park Cancer Institute

Overall Clinical Trial Officials and Contacts

Donald L. Trump, MD Principal Investigator Roswell Park Cancer Institute  

Information obtained from ClinicalTrials.gov on August 08, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00559481

Study ID Number: CDR0000574126

ClinicalTrials.gov Identifier: NCT00559481

Health Authority: Unspecified

Clinical trial summary from the National Cancer Institute's PDQ® database