NCT00524589

Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

Phase II Study of Weekly Intravenous 1,25 Dihydroxycholecelciferol (Calcitriol) + Dexamethasone in Androgen Independent Prostate Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: Male
• Age: 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	calcitriol	IV
DRUG	dexamethasone	Oral
GENETIC	protein expression analysis	Correlative Study
OTHER	laboratory biomarker analysis	Correlative Study

Timeline

• Start date: 2006-04-01
• Primary completion: 2010-07-01
• Completion: 2010-09-01
• First posted: 2007-09-03
• Last updated: 2017-11-20
• Results posted: 2014-03-10

Locations

1 site across 1 country: United States