Status:
COMPLETED
Atorvastatin Calcium and Celecoxib in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
Rutgers Cancer Institute of New Jersey
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18-120 years
Phase:
PHASE2
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 mo...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2014
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01220973
Start Date
February 1 2009
End Date
November 18 2014
Last Update
June 8 2018
Active Locations (4)
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1
Karmanos Cancer Center
Detroit, Michigan, United States, 48201
2
Cooper Hospital
Camden, New Jersey, United States, 08103
3
Robert Wood Johnson University Hospital at Hamilton
Hamilton, New Jersey, United States, 08690
4
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903