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

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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: 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
We are reporting results on 27 eligible patients. Seven patients were deemed ineligible.

Reporting Groups
  Description
Atorvastatin and Celecoxib

atorvastatin calcium

celecoxib

laboratory biomarker analysis


Participant Flow:   Overall Study
    Atorvastatin and Celecoxib
STARTED   27 
COMPLETED   23 
NOT COMPLETED   4 



  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
Atorvastatin and Celecoxib

atorvastatin calcium

celecoxib

laboratory biomarker analysis


Baseline Measures
   Atorvastatin and Celecoxib 
Overall Participants Analyzed 
[Units: Participants]
 27 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      6  22.2% 
>=65 years      21  77.8% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      27 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      27 100.0% 
Unknown or Not Reported      0   0.0% 
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  22.2% 
White      21  77.8% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   27 


  Outcome Measures

1.  Primary:   PSA Response   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  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

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


Results Point of Contact:  
Name/Title: Susan Goodin PharmD, FCCP, BCOP
Organization: Rutgers Cancer Institute of New Jersey
phone: 732-235-6783
e-mail: goodin@cinj.rutgers.edu



Responsible Party: Susan Goodin, PharmD, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01220973     History of Changes
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