Ketoconazole, Dexamethasone, and Hydrocortisone in Treating Patients With Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy
Primary Purpose
Prostate Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
dexamethasone
ketoconazole
therapeutic hydrocortisone
pharmacological study
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring recurrent prostate cancer
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
Sites / Locations
Outcomes
Primary Outcome Measures
Pharmacokinetics of oral dexamethasone with and without oral ketoconazole
Pharmacokinetics of oral hydrocortisone with and without oral ketoconazole
Secondary Outcome Measures
Full Information
NCT ID
NCT00559481
First Posted
November 15, 2007
Last Updated
January 31, 2013
Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00559481
Brief Title
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
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn due to low accrual
Study Start Date
October 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
recurrent prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Type
Drug
Intervention Name(s)
ketoconazole
Intervention Type
Drug
Intervention Name(s)
therapeutic hydrocortisone
Intervention Type
Procedure
Intervention Name(s)
pharmacological study
Primary Outcome Measure Information:
Title
Pharmacokinetics of oral dexamethasone with and without oral ketoconazole
Title
Pharmacokinetics of oral hydrocortisone with and without oral ketoconazole
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald L. Trump, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Ketoconazole, Dexamethasone, and Hydrocortisone in Treating Patients With Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy
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