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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:
ClinicalTrials.gov Identifier:
NCT00536991
First Posted: September 28, 2007
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute
Results First Submitted: April 5, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   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
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Reporting Groups
  Description
Phase I/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 I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone
STARTED   51 
COMPLETED   38 
NOT COMPLETED   13 
Withdrawal by Subject                10 
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 treated and eligible patients

Reporting Groups
  Description
Phase I/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 I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone 
Overall Participants Analyzed 
[Units: Participants]
 51 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      18  35.3% 
>=65 years      33  64.7% 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.0  (8.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      51 100.0% 
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      6  11.8% 
White      45  88.2% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Determine the Maximum Tolerated Dose (MTD)   [ Time Frame: up to 11 years ]

2.  Primary:   PSA Response Rate   [ Time Frame: Up to 11 years ]

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

4.  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 ( U.S. NIH Grant/Contract )
First Submitted: September 27, 2007
First Posted: September 28, 2007
Results First Submitted: April 5, 2017
Results First Posted: May 15, 2017
Last Update Posted: June 14, 2017



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