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NCT00536991 · ClinicalTrials.gov registry record · Phase 1
Calcitriol in Combination With Ketoconazole and Therapeutic Hydrocortisone in Treating Patients With Prostate Cancer
A Phase 1 study, sponsored by Roswell Park Cancer Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT00536991: Clinical Trial Phase 1 study, sponsored by Roswell Park Cancer Institute.
NCT00536991 is a Phase 1 study that was terminated before completion, run by Roswell Park Cancer Institute. The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00536991, a Phase 1 study, was terminated before completion, sponsored by Roswell Park Cancer Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and best dose of calcitriol when given in combination with ketoconazole and therapeutic hydrocortisone and to see how well it works in treating patients with prostate cancer. Calcitriol may help prostate cancer cells become more like normal cells and grow and spread more slowly. Ketoconazole and therapeutic hydrocortisone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with ketoconazole and therapeutic hydrocortisone may be a better treatment for prostate cancer.
Primary Outcome
Determine the maximum tolerated dose (MTD) of oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole (400 mg thrice daily \[TID\]) + oral hydrocortisone (20 mg AM, 10 mg PM)
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Therapeutic Hydrocortisone
- OTHER Pharmacological Study
- DRUG Ketoconazole
- DIETARY_SUPPLEMENT Calcitriol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2006-10 |
| Est. Completion | 2016-10 |
| Phase | Phase 1 |
Why NCT00536991 stopped before completion
NCT00536991 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00536991 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00536991 about?
NCT00536991 is a clinical study titled "Calcitriol in Combination With Ketoconazole and Therapeutic Hydrocortisone in Treating Patients With Prostate Cancer". This phase I/II trial studies the side effects and best dose of calcitriol when given in combination with ketoconazole and therapeutic hydrocortisone and to see how well it works in treating patients with prostate cancer. Calcitriol may help prostate cancer cells become more like normal cells and gr...
What is the current status of trial NCT00536991?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2006-10. Estimated completion is 2016-10.
What interventions are being tested in trial NCT00536991?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Therapeutic Hydrocortisone (DRUG), Pharmacological Study (OTHER), Ketoconazole (DRUG), Calcitriol (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00536991?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00536991's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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