Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE October 13, 2010
First Posted Date  ICMJE October 14, 2010
Results First Submitted Date  ICMJE April 17, 2017
Results First Posted Date  ICMJE April 20, 2018
Last Update Posted Date June 8, 2018
Study Start Date  ICMJE February 2009
Actual Primary Completion Date November 18, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2018)
PSA Response [ Time Frame: 6 months ]
PSA response was defined as a decrease in slope of at least 25%, when log (PSA) is plotted vs. time.
Original Primary Outcome Measures  ICMJE
 (submitted: October 13, 2010)
PSA Response
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Atorvastatin Calcium and Celecoxib in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer
Official Title  ICMJE Phase II Trial of Atorvastatin and Celecoxib in Patients With Hormone-Dependent Prostate-Specific Antigen Progression After Local Therapy for Prostate Cancer.
Brief Summary

RATIONALE: Atorvastatin calcium and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atorvastatin calcium together with celecoxib may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving atorvastatin calcium together with celecoxib works in treating patients with rising PSA levels after local therapy for prostate cancer.

Detailed Description

OBJECTIVES:

Primary

  • To determine the effect on the biological activity, as assessed by prostate-specific antigen (PSA) response, of atorvastatin calcium and celecoxib in patients with D0 prostate cancer.

Secondary

  • To document the safety and feasibility of atorvastatin calcium and celecoxib in patients with early-stage prostate cancer.
  • To evaluate the effects of the combination of atorvastatin calcium and celecoxib on nuclear factor-kB (NFkB), extracellular signal-regulated kinase (ERK), prostaglandin E2 (PGE2), and IL6 in peripheral blood mononuclear cells (PBMC).

OUTLINE: This is a multicenter study.

Patients receive oral atorvastatin calcium once daily and oral celecoxib twice daily on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients may undergo blood sample collection at baseline and after completion of study therapy for correlative studies.

After completion of study therapy, patients are followed up every 3 months for 2 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: atorvastatin calcium
  • Drug: celecoxib
  • Other: laboratory biomarker analysis
Study Arms  ICMJE Experimental: Atorvastatin and Celecoxib
Interventions:
  • Drug: atorvastatin calcium
  • Drug: celecoxib
  • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2010)
27
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 18, 2014
Actual Primary Completion Date November 18, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer

    • Stage D0 disease

      • Tumor originally diagnosed as being limited to the prostate and now having a rising prostate-specific antigen (PSA) after definitive local therapy
  • Must have undergone local treatment via prostatectomy or radiotherapy

    • PSA values must be ≥ 0.2 ng/mL as determined by 2 measurements, ≥ 1 month apart and ≥ 6 months after prostatectomy
    • PSA values must be ≥ 2.0 ng/mL as determined by 2 measurements, ≥ 1 month apart and ≥ 6 months after radiotherapy
    • The first two PSA values along with a third value must all be rising (i.e., there must be an overall rising trajectory, such that the third value cannot be lower than the first value)
  • No metastatic disease by baseline bone scan and CT scan of the abdomen and/or pelvis

PATIENT CHARACTERISTICS:

  • Life expectancy ≥ 6 months
  • ECOG performance status 0-2
  • WBC ≥ 3,500/µL
  • ANC ≥ 1,500/µL
  • Platelet count > 100,000/µL
  • Hemoglobin > 10 g/dL
  • Serum creatinine < 1.5 mg/dL OR creatinine clearance > 50 mL/min
  • Total bilirubin normal
  • SGOT and/or SGPT normal
  • No serious concomitant systemic disorder that, at the discretion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
  • No second primary malignancy within the past 5 years except adequately treated in situ carcinoma (e.g., non-melanomatous carcinoma of the skin) or other malignancy with no evidence of recurrence
  • No active clinically significant infection requiring antibiotics
  • No history of coronary artery disease
  • No myocardial infarction within the past 6 months
  • No sulfa allergy
  • No history of gastrointestinal bleeding

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior hormone-ablative treatment

    • Prior neoadjuvant hormone-ablative therapy allowed provided it was completed ≥ 3 months ago
  • More than 4 weeks since prior herbal products with hormonal activity such as soy, saw palmetto, or PC-SPES
  • No prior or concurrent nonsteroidal anti-inflammatory drug (NSAIDS) for 7 consecutive days
  • No COX-2 inhibitor and/or statin within the past 6 months
  • No concurrent warfarin or any other anticoagulant, calcitriol, fibric acid derivatives, lipid-modifying doses of niacin, or strong cytochrome P450 3A4 inhibitors (e.g., cyclosporine, erythromycin, clarithromycin, and azole antifungals) or inducers (e.g., St John wort)
  • No other concurrent anticancer agents or therapies including chemotherapy, hormonal therapy, radiotherapy, or experimental therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01220973
Other Study ID Numbers  ICMJE 0220090006, 080811
0220090006 ( Other Identifier: IRB number )
NCI-2012-00540 ( Other Identifier: CTRP (Clinical Trails Reporting Program) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Susan Goodin, PharmD, Rutgers, The State University of New Jersey
Study Sponsor  ICMJE Rutgers, The State University of New Jersey
Collaborators  ICMJE
  • Rutgers Cancer Institute of New Jersey
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Susan Goodin, PhD, FCCP, BCOP Rutgers Cancer Institute of New Jersey
PRS Account Rutgers, The State University of New Jersey
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP