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

This study has been terminated.
(closed due to futility)
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00524589
First received: August 31, 2007
Last updated: January 27, 2014
Last verified: January 2014
Results First Received: January 27, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Dietary Supplement: calcitriol
Drug: dexamethasone
Genetic: protein expression analysis
Other: laboratory biomarker analysis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

calcitriol: IV

dexamethasone: Oral

protein expression analysis: Correlative Study

laboratory biomarker analysis: Correlative Study


Participant Flow:   Overall Study
    Dexamethasone and Calcitriol  
STARTED     18  
COMPLETED     0  
NOT COMPLETED     18  
Withdrawal by Subject                 2  
Disease Progression                 16  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All treated and eligible patients

Reporting Groups
  Description
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.

calcitriol: IV

dexamethasone: Oral

protein expression analysis: Correlative Study

laboratory biomarker analysis: Correlative Study


Baseline Measures
    Dexamethasone and Calcitriol  
Number of Participants  
[units: participants]
  18  
Age  
[units: years]
Mean ± Standard Deviation
  68.2  ± 11.8  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     7  
>=65 years     11  
Gender  
[units: participants]
 
Female     0  
Male     18  



  Outcome Measures

1.  Primary:   Objective Response (Complete or Partial Response)   [ Time Frame: 1 year ]

2.  Secondary:   Expression of VDR and CYP24 in Peripheral Blood Mononuclear Cells as Assessed at Baseline and on Days 2 and 3   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
phone: 716-845-2300


No publications provided


Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00524589     History of Changes
Other Study ID Numbers: CDR0000563197, RPCI I-65405
Study First Received: August 31, 2007
Results First Received: January 27, 2014
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration