Clinical trial NCT00559481: Ketoconazole, Dexamethasone, and Hydrocortisone in Treating 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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Cancer
Keywords: recurrent prostate cancer
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-11-16
Enrollment: 0
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Pharmacokinetics of oral dexamethasone with and without oral ketoconazole
measure: Pharmacokinetics of oral hydrocortisone with and without oral ketoconazole
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Roswell Park Cancer Institute
name: Donald L. Trump, MD
role: PRINCIPAL_INVESTIGATOR
References: