Prostate CancerNCT00559481
Ketoconazole, Dexamethasone, and Hydrocortisone in Treating Patients With Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy
A study testing dexamethasone, ketoconazole and therapeutic hydrocortisone in people with Prostate Cancer, run by Roswell Park Cancer Institute.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- dexamethasone, ketoconazole and therapeutic hydrocortisone
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Sep 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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
About this study
Official title: Effect of Oral Ketoconazole on the Pharmacokinetics of Oral Dexamethasone and Oral Hydrocortisone in Patients With Androgen Independent Prostate Cancer
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- dexamethasone, ketoconazole, therapeutic hydrocortisone, pharmacological study
- Keywords
- recurrent prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
ketoconazoleDrug
therapeutic hydrocortisoneDrug
pharmacological studyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of oral dexamethasone with and without oral ketoconazole
Pharmacokinetics of oral hydrocortisone with and without oral ketoconazole
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionSep 2008
Why it stopped: Withdrawn due to low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Donald L. Trump, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559481
- Sponsor's protocol ID
- I 93506
- Other IDs
- RPCI-I-93506
- Status last verified
- Jan 2013
- First submitted
- 15 Nov 2007
- Last updated
- 1 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Ketoconazole on the Pharmacokinetics of Oral Dexamethasone and Oral Hydrocortisone in Patients With Androgen Independent Prostate Cancer
- ClinicalTrials.gov ID
- NCT00559481
- Acronym / sponsor ID
- I 93506
- Conditions
- Prostate Cancer
- Keywords
- recurrent prostate cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to low accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2007
- Primary completion
- Sep 2008 (actual)
- First posted
- 16 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexamethasone | Drug | – |
| ketoconazole | Drug | – |
| therapeutic hydrocortisone | Drug | – |
| pharmacological study | Procedure or surgery | – |
Primary outcome
Pharmacokinetics of oral dexamethasone with and without oral ketoconazole
Pharmacokinetics of oral hydrocortisone with and without oral ketoconazole
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2013.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald L. Trump, MD principal investigator
Roswell Park Cancer Institute
Questions about this trial
What is this clinical trial studying?
A study testing dexamethasone, ketoconazole and therapeutic hydrocortisone in people with Prostate Cancer, run by Roswell Park Cancer Institute.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of oral dexamethasone with and without oral ketoconazole. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2013.