Phase II Study of Weekly Intravenous 1,25 Dihydroxycholecelciferol (Calcitriol) + Dexamethasone in Androgen Independent Prostate Cancer
OBJECTIVES:
- 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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response (complete or partial response)
1 year
No
Donald L. Trump, MD
Principal Investigator
Roswell Park Cancer Institute
United States: Institutional Review Board
CDR0000563197
NCT00524589
April 2006
September 2010
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |