Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
RATIONALE: Calcitriol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. Dexamethasone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with dexamethasone may be an effective treatment for prostate cancer that did not respond to hormone therapy .
PURPOSE: This phase II trial is studying how well giving calcitriol together with dexamethasone works in treating patients with prostate cancer that did not respond to hormone therapy.
|Prostate Cancer||Dietary Supplement: calcitriol Drug: dexamethasone Genetic: protein expression analysis Other: laboratory biomarker analysis||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Weekly Intravenous 1,25 Dihydroxycholecelciferol (Calcitriol) + Dexamethasone in Androgen Independent Prostate Cancer|
- Objective Response (Complete or Partial Response) [ Time Frame: 1 year ]
- Expression of VDR and CYP24 in Peripheral Blood Mononuclear Cells as Assessed at Baseline and on Days 2 and 3 [ Time Frame: 1 year ]
|Study Start Date:||April 2006|
|Study Completion Date:||September 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Experimental: Dexamethasone and Calcitriol
Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.
Dietary Supplement: calcitriol
OralGenetic: protein expression analysis
Correlative StudyOther: laboratory biomarker analysis
- To investigate the response rate in patients with androgen-independent prostate cancer treated with calcitriol and dexamethasone.
- To evaluate the toxicity of high-dose calcitriol and dexamethasone in these patients.
OUTLINE: Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and on days 2 and 3 to assess VDR and CYP24 expression in peripheral blood mononuclear cells.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00524589
|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|