Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
|ClinicalTrials.gov Identifier: NCT00524589|
Recruitment Status : Terminated (closed due to futility)
First Posted : September 3, 2007
Results First Posted : March 10, 2014
Last Update Posted : November 20, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Dietary Supplement: calcitriol Drug: dexamethasone Genetic: protein expression analysis Other: laboratory biomarker analysis||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Weekly Intravenous 1,25 Dihydroxycholecelciferol (Calcitriol) + Dexamethasone in Androgen Independent Prostate Cancer|
|Study Start Date :||April 2006|
|Primary Completion Date :||July 2010|
|Study Completion Date :||September 2010|
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
- Objective Response (Complete or Partial Response) [ Time Frame: 1 year ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Corrected Serum Calcium Expression [ Time Frame: 1 year ]Number of patients with corrected serum calcium levels between 11 mg/dL and 12 mg/dL detected on 1 or more occasions.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|