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Tracking Information | |||||
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First Received Date † | September 27, 2007 | ||||
Last Updated Date | April 18, 2009 | ||||
Start Date † | October 2006 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00536991 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Calcitriol, Ketoconazole, and Hydrocortisone in Treating Patients With Advanced or Recurrent Prostate Cancer | ||||
Official Title † | A Phase I/II Study of Oral Calcitriol in Combination With Ketoconazole in Androgen Independent Prostate Cancer | ||||
Brief Summary | RATIONALE: Calcitriol may help prostate cancer cells become more like normal cells and grow and spread more slowly. Ketoconazole may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with ketoconazole and hydrocortisone may be an effective treatment for prostate cancer. PURPOSE: This phase I/II trial is studying the side effects and best dose of calcitriol when given together with ketoconazole and hydrocortisone and to see how well it works in treating patients with advanced or recurrent prostate cancer. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a phase I, dose-escalation study of calcitriol followed by a phase II study.
Peripheral blood mononuclear cells are collected periodically to evaluate the pharmacodynamics of calcitriol, hydrocortisone, and ketoconazole. Some patients undergo blood collection on days 1 and 15 for calcitriol pharmacokinetic studies. |
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Study Phase | Phase I, Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment | ||||
Condition † | Prostate Cancer | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | 60 | ||||
Completion Date | |||||
Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Male | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00536991 | ||||
Responsible Party | Donald L. Trump, Roswell Park Cancer Institute | ||||
Secondary IDs †† | RPCI-I-68905 | ||||
Study Sponsor † | Roswell Park Cancer Institute | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | April 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |