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Calcitriol in Combination With Ketoconazole and Therapeutic Hydrocortisone in Treating Patients With Prostate Cancer

This study has been terminated.
(difficult to recruit)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00536991
First received: September 27, 2007
Last updated: April 5, 2017
Last verified: April 2017
Results First Received: April 5, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Prostate Adenocarcinoma
Recurrent Prostate Carcinoma
Stage III Prostate Cancer
Stage IV Prostate Cancer
Interventions: Dietary Supplement: Calcitriol
Drug: Ketoconazole
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Drug: Therapeutic Hydrocortisone

  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
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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
Phase II: Oral Calcitriol, Ketoconazole, Hydrocortisone oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole, (400 mg TID) + oral hydrocortisone (20mg AM, 10mg PM) in men with androgen independent prostate cancer (AIPC).

Participant Flow:   Overall Study
    Phase II: Oral Calcitriol, Ketoconazole, Hydrocortisone
STARTED   37 
COMPLETED   27 
NOT COMPLETED   10 
Withdrawal by Subject                7 
Physician Decision                1 
patient ineligible                2 



  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 Phase II patients

Reporting Groups
  Description
Phase II: Oral Calcitriol, Ketoconazole, Hydrocortisone oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole, (400 mg TID) + oral hydrocortisone (20mg AM, 10mg PM) in men with androgen independent prostate cancer (AIPC).

Baseline Measures
   Phase II: Oral Calcitriol, Ketoconazole, Hydrocortisone 
Overall Participants Analyzed 
[Units: Participants]
 37 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      13  35.1% 
>=65 years      24  64.9% 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.8  (8.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      37 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      4  10.8% 
White      33  89.2% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   PSA Response Rate (Phase II)   [ Time Frame: Up to 11 years ]

2.  Secondary:   Incidence of Toxicity Graded According to the National Cancer Institute CTC Version 3.0   [ Time Frame: Up to 11 years ]

3.  Secondary:   Objective Tumor Response, Assessed by RECIST   [ Time Frame: Up to 11 years ]


  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



Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00536991     History of Changes
Other Study ID Numbers: I 68905
NCI-2011-00129 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
RPCI-I-68905
I 68905 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( US NIH Grant/Contract Award Number )
Study First Received: September 27, 2007
Results First Received: April 5, 2017
Last Updated: April 5, 2017