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

Condition(s) targeted: Prostate Cancer

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

Phase: N/A

Status: Recruiting

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.

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

Study design: Treatment, Randomized, Open Label

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.

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

Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States; Recruiting
Donald L. Trump, MD, Phone: 716-845-5772, Email: donald.trump@roswellpark.org

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

Starting date: October 2007
Last updated: October 8, 2008