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

• Status: Completed
• Trial end date: 2014-11-18
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI); Rutgers Cancer Institute of New Jersey
• Treatments: Atorvastatin; Atorvastatin Calcium; Calcium; Calcium, Dietary; Celecoxib

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