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Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00536991 |
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.
Condition | Intervention | Phase |
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Prostate Cancer |
Dietary Supplement: calcitriol Drug: ketoconazole Drug: therapeutic hydrocortisone |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Study of Oral Calcitriol in Combination With Ketoconazole in Androgen Independent Prostate Cancer |
Estimated Enrollment: | 60 |
Study Start Date: | October 2006 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a phase I, dose-escalation study of calcitriol followed by a phase II study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed androgen-independent adenocarcinoma of the prostate
PATIENT CHARACTERISTICS:
No heart failure or significant heart disease, including any of the following:
No other severe or uncontrolled systemic disease (e.g., unstable or compensated respiratory, cardiac, hepatic, or renal disease) or intercurrent illness including, but not limited to any of the following:
PRIOR CONCURRENT THERAPY:
No more than 2 prior cytotoxic chemotherapy regimens
No concurrent use of any of the following:
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 |
Principal Investigator: | Donald L. Trump, MD | Roswell Park Cancer Institute |
Responsible Party: | Roswell Park Cancer Institute ( Donald L. Trump ) |
Study ID Numbers: | CDR0000565063, RPCI-I-68905 |
Study First Received: | September 27, 2007 |
Last Updated: | April 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00536991 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate recurrent prostate cancer stage III prostate cancer stage IV prostate cancer |
Anti-Inflammatory Agents Anti-Infective Agents Hydrocortisone Genital Neoplasms, Male Prostatic Diseases Cortisol succinate Bone Density Conservation Agents Trace Elements Urogenital Neoplasms Cardiovascular Agents Genital Diseases, Male Ketoconazole |
Recurrence Calcitriol Calcium, Dietary Antifungal Agents Vitamins Vasoconstrictor Agents Micronutrients Hydrocortisone acetate Adenocarcinoma Prostatic Neoplasms Androgens |
Anti-Inflammatory Agents Anti-Infective Agents Hydrocortisone Prostatic Diseases Genital Neoplasms, Male Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Calcium Channel Agonists Urogenital Neoplasms Bone Density Conservation Agents Calcitriol Membrane Transport Modulators Neoplasms by Site Antifungal Agents |
Vitamins Therapeutic Uses Vasoconstrictor Agents Micronutrients Cortisol succinate Growth Substances Cardiovascular Agents Ketoconazole Genital Diseases, Male Pharmacologic Actions Neoplasms Hydrocortisone acetate Prostatic Neoplasms |