 |
|
Randomized Study of the Effect of Ketoconazole on the Pharmacokinetics of Dexamethasone and Hydrocortisone in Patients With Androgen-Independent Prostate Cancer
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Ketoconazole, Dexamethasone, and Hydrocortisone in Treating Patients With Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy
Basic Trial Information
|
Phase
|
|
|
|
Type
|
|
|
|
Status
|
|
|
|
Age
|
|
|
|
Sponsor
|
|
|
|
Protocol IDs
|
|
|
|
No phase specified
|
|
|
|
Biomarker/Laboratory analysis, Treatment
|
|
|
|
Active
|
|
|
|
Not specified
|
|
|
|
NCI
|
|
|
|
RPCI-I-93506
I 93506, NCT00559481
|
|
|
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.
Entry Criteria Disease Characteristics:
- Confirmed diagnosis of prostate cancer
- Must have failed standard androgen-deprivation therapy
Prior/Concurrent Therapy:
- More than 2 weeks since prior and no concurrent drugs known to interact with study treatment
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
Expected Enrollment 12Outcomes Primary Outcome(s)Pharmacokinetics of oral dexamethasone with and without oral ketoconazole
Pharmacokinetics of oral hydrocortisone with and without oral ketoconazole
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.
Trial Contact Information
Trial Lead Organizations Roswell Park Cancer Institute | | | | Donald Trump, MD, Principal investigator | | | |
Trial Sites
| Registry Information | | | Official Title | | Effect of Oral Ketoconazole on the Pharmacokinetics of Oral Dexamethasone and Oral Hydrocortisone in Patients with Androgen Independent Prostate Cancer | | | Trial Start Date | | 2007-10-16 | | | Trial Completion Date | | 2010-01-04 (estimated) | | | Registered in ClinicalTrials.gov | | NCT00559481 | | | Date Submitted to PDQ | | 2007-10-22 | | | Information Last Verified | | 2008-04-20 | | | NCI Grant/Contract Number | | CA16056 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
 |
