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

Information source: Roswell Park Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: dexamethasone (Drug); ketoconazole (Drug); therapeutic hydrocortisone (Drug); pharmacological study (Procedure)

Phase: N/A

Status: Withdrawn

Sponsored by: Roswell Park Cancer Institute

Official(s) and/or principal investigator(s):
Donald L. Trump, MD, Principal Investigator, Affiliation: Roswell Park Cancer Institute


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.

Clinical Details

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

Study design: Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Pharmacokinetics of oral dexamethasone with and without oral ketoconazole

Pharmacokinetics of oral hydrocortisone with and without oral ketoconazole

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.


Minimum age: N/A. Maximum age: N/A. Gender(s): Male.



- Confirmed diagnosis of prostate cancer

- Must have failed standard androgen-deprivation therapy

- Evidence of rising PSA


- 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


Locations and Contacts

Additional Information

Starting date: October 2007
Last updated: January 31, 2013

Page last updated: August 23, 2015

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