Prostate Cancer
Conditions
Keywords
stage IV prostate cancer, stage III prostate cancer, recurrent prostate cancer, stage IIB prostate cancer, stage IIA 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.
Interventions
DRUGatorvastatin calcium
DRUGcelecoxib
OTHERlaboratory biomarker analysis
Sponsors
Rutgers Cancer Institute of New Jersey
National Cancer Institute (NCI)
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PSA Response | 6 months | PSA response was defined as a decrease in slope of at least 25%, when log (PSA) is plotted vs. time. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited through the Rutgers Cancer Institute of New Jersey Oncology Group. The study was open to accrual on 02/25/2009 and closed to accrual on 11/13/2012.
Pre-assignment details
We are reporting results on 27 eligible patients. Seven patients were deemed ineligible.
Participants by arm
| Arm | Count |
|---|---|
| Atorvastatin and Celecoxib atorvastatin calcium
celecoxib
laboratory biomarker analysis | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Atorvastatin and Celecoxib |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 21 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
PSA Response
PSA response was defined as a decrease in slope of at least 25%, when log (PSA) is plotted vs. time.
Time frame: 6 months
Population: A total of 27 patients were enrolled but only 26 were evaluable as one patient withdrew consent prior to starting therapy.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Atorvastatin and Celecoxib | PSA Response | 14 Participants |