Trials / Withdrawn

WithdrawnNCT00559481

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

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

Status: Withdrawn
Phase: N/A
Study type: Interventional
Enrollment: 0 (actual)

Sponsor: Roswell Park Cancer Institute · Academic / Other
Sex: Male
Age: —
Healthy volunteers: Not accepted

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.

Conditions

Prostate Cancer

Interventions

Type	Name	Description
DRUG	dexamethasone
DRUG	ketoconazole
DRUG	therapeutic hydrocortisone
PROCEDURE	pharmacological study

Timeline

Start date: 2007-10-01
Primary completion: 2008-09-01
First posted: 2007-11-16
Last updated: 2013-02-01

Source: ClinicalTrials.gov record NCT00559481. Inclusion in this directory is not an endorsement.