Atorvastatin Calcium and Celecoxib in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: atorvastatin calcium; celecoxib; laboratory biomarker analysis
Intervention MeSH terms: Celecoxib; Atorvastatin; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: Male
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IV prostate cancer; stage III prostate cancer; recurrent prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer

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.
    

Eligibility criteria:

        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