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Atorvastatin Calcium and Celecoxib in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer

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.
 
ClinicalTrials.gov Identifier: NCT01220973
Recruitment Status : Completed
First Posted : October 14, 2010
Results First Posted : April 20, 2018
Last Update Posted : June 8, 2018
Sponsor:
Collaborators:
Rutgers Cancer Institute of New Jersey
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Susan Goodin, PharmD, Rutgers, The State University of New Jersey

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: atorvastatin calcium
Drug: celecoxib
Other: laboratory biomarker analysis
Enrollment 27
Recruitment Details Subjects were recruited through the Rutgers Cancer Institute of New Jersey Oncology Group. The study was open to accrual on 02/25/2009 and closed to accrual on 11/13/2012.
Pre-assignment Details We are reporting results on 27 eligible patients. Seven patients were deemed ineligible.
Arm/Group Title Atorvastatin and Celecoxib
Hide Arm/Group Description

atorvastatin calcium

celecoxib

laboratory biomarker analysis

Period Title: Overall Study
Started 27
Completed 23
Not Completed 4
Arm/Group Title Atorvastatin and Celecoxib
Hide Arm/Group Description

atorvastatin calcium

celecoxib

laboratory biomarker analysis

Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  22.2%
>=65 years
21
  77.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
0
   0.0%
Male
27
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
27
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 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
  22.2%
White
21
  77.8%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants
27
1.Primary Outcome
Title PSA Response
Hide Description PSA response was defined as a decrease in slope of at least 25%, when log (PSA) is plotted vs. time.
Time Frame 6 months
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Hide Analysis Population Description
A total of 27 patients were enrolled but only 26 were evaluable as one patient withdrew consent prior to starting therapy.
Arm/Group Title Atorvastatin and Celecoxib
Hide Arm/Group Description:

atorvastatin calcium

celecoxib

laboratory biomarker analysis

Overall Number of Participants Analyzed 26
Measure Type: Count of Participants
Unit of Measure: Participants
14
  53.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin and Celecoxib
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.74
Estimation Comments [Not Specified]
Time Frame Adverse events were collected over a period of 900 days per patient.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atorvastatin and Celecoxib
Hide Arm/Group Description

atorvastatin calcium

celecoxib

laboratory biomarker analysis

All-Cause Mortality
Atorvastatin and Celecoxib
Affected / at Risk (%)
Total   0/27 (0.00%) 
Hide Serious Adverse Events
Atorvastatin and Celecoxib
Affected / at Risk (%)
Total   0/27 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Atorvastatin and Celecoxib
Affected / at Risk (%)
Total   0/27 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Susan Goodin PharmD, FCCP, BCOP
Organization: Rutgers Cancer Institute of New Jersey
Phone: 732-235-6783
EMail: goodin@cinj.rutgers.edu
Layout table for additonal information
Responsible Party: Susan Goodin, PharmD, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01220973    
Other Study ID Numbers: 0220090006, 080811
0220090006 ( Other Identifier: IRB number )
NCI-2012-00540 ( Other Identifier: CTRP (Clinical Trails Reporting Program) )
First Submitted: October 13, 2010
First Posted: October 14, 2010
Results First Submitted: April 17, 2017
Results First Posted: April 20, 2018
Last Update Posted: June 8, 2018