Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00460031
First received: April 11, 2007
Last updated: May 16, 2016
Last verified: May 2016
Results First Received: July 14, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: ketoconazole
Drug: lenalidomide
Drug: therapeutic hydrocortisone

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Thirty seven (37) patients were screened from Cleveland Clinic and University Hospitals in the Cleveland area from February 2007 to April 2009.Three patients were not eligible.

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
Ketoconazole Plus Lenalidomide Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.

Participant Flow:   Overall Study
    Ketoconazole Plus Lenalidomide  
STARTED     34  
COMPLETED     23  
NOT COMPLETED     11  
Adverse Event                 5  
Withdrawal by Subject                 5  
Death                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Ketoconazole Plus Lenalidomide Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.

Baseline Measures
    Ketoconazole Plus Lenalidomide  
Number of Participants  
[units: participants]
  34  
Age, Customized  
[units: participants]
 
40-49 years     2  
50-59 years     5  
60-69 years     10  
70-79 years     11  
80-89 years     6  
Gender  
[units: participants]
 
Female     0  
Male     34  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     33  
Unknown or Not Reported     1  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     3  
White     30  
More than one race     0  
Unknown or Not Reported     1  
Region of Enrollment  
[units: participants]
 
United States     34  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients With a Partial Response, Progressive Disease, or Stable Disease Based on Prostate-Specific Antigen (PSA) or Measurable Disease   [ Time Frame: 28 days ]

2.  Secondary:   Time to Progression   [ Time Frame: One year (12 months) after start of treatment ]

3.  Secondary:   Number of Patients With Grade 3 and 4 Toxicity as Assessed by NCI CTCAE v3.0   [ Time Frame: Up to 30 days after discontinuation of treatment ]

4.  Secondary:   Change in Immune Response From Baseline   [ Time Frame: Week 8 ]

5.  Secondary:   Ratio of Change in Immune Response From Baseline   [ Time Frame: Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Jorge Garcia
Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
phone: 216-444-7774
e-mail: garciaj4@ccf.org



Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00460031     History of Changes
Other Study ID Numbers: CASE12805
P30CA043703 ( US NIH Grant/Contract Award Number )
Study First Received: April 11, 2007
Results First Received: July 14, 2014
Last Updated: May 16, 2016
Health Authority: United States: Food and Drug Administration