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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01220973
First received: October 13, 2010
Last updated: May 5, 2014
Last verified: May 2014

October 13, 2010
May 5, 2014
February 2009
November 2014   (final data collection date for primary outcome measure)
PSA response [ Time Frame: up to 2.5 years (6 months therapy and 2 years of follow-up) ] [ Designated as safety issue: No ]
PSA response [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01220973 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Atorvastatin Calcium and Celecoxib in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer
Phase II Trial of Atorvastatin and Celecoxib in Patients With Hormone-Dependent Prostate-Specific Antigen Progression After Local Therapy for Prostate Cancer.

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Drug: atorvastatin calcium
  • Drug: celecoxib
  • Other: laboratory biomarker analysis
Experimental: Atorvastatin and Celecoxib
Interventions:
  • Drug: atorvastatin calcium
  • Drug: celecoxib
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
27
Not Provided
November 2014   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01220973
080811, 0220090006
No
Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
  • Rutgers Cancer Institute of New Jersey
  • National Cancer Institute (NCI)
Principal Investigator: Susan Goodin, PharmD, FCCP, BCOP Rutgers Cancer Institute of New Jersey
Rutgers, The State University of New Jersey
May 2014

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