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Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00559481

Enrollment

Registered

2007-11-16

Start date

2007-10-31

Completion date

Unknown

Last updated

2013-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer

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.

Interventions

DRUGdexamethasone

DRUGketoconazole

DRUGtherapeutic hydrocortisone

PROCEDUREpharmacological study

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics of oral dexamethasone with and without oral ketoconazole	—
Pharmacokinetics of oral hydrocortisone with and without oral ketoconazole	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026