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Status: Withdrawn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
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.
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 ketoconazolePharmacokinetics 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.
Eligibility
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
Locations and Contacts
Additional Information
Starting date: October 2007
Last updated: January 31, 2013
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