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

Not Applicable

Withdrawn

• Conditions: Prostate Cancer

• Registration Number: NCT00559481
• Lead Sponsor: Roswell Park Cancer Institute

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.

In both arms, patients undergo blood sample collection on days 1, 14, 29, and 42 for pharmacokinetic studies.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-11-15
• Study First Submitted QC: 2007-11-15
• Study First Posted: 2007-11-16
• Primary Completion: 2008-09
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-31
• Last Update Posted: 2013-02-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of oral dexamethasone with and without oral ketoconazole
Pharmacokinetics of oral hydrocortisone with and without oral ketoconazole