Atorvastatin Calcium and Celecoxib in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: atorvastatin calcium Drug: celecoxib Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Atorvastatin and Celecoxib in Patients With Hormone-Dependent Prostate-Specific Antigen Progression After Local Therapy for Prostate Cancer. |
- PSA response [ Time Frame: up to 2.5 years (6 months therapy and 2 years of follow-up) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 27 |
| Study Start Date: | February 2009 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Atorvastatin and Celecoxib | Drug: atorvastatin calcium Drug: celecoxib Other: laboratory biomarker analysis |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Michigan | |
| Karmanos Cancer Center | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Jersey | |
| Cooper Hospital | |
| Camden, New Jersey, United States, 08103 | |
| Robert Wood Johnson University Hospital at Hamilton | |
| Hamilton, New Jersey, United States, 08690 | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| Principal Investigator: | Susan Goodin, PharmD, FCCP, BCOP | Cancer Institute of New Jersey |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT01220973 History of Changes |
| Other Study ID Numbers: | CDR0000636488, CINJ-080811, 0220090006 |
| Study First Received: | October 13, 2010 |
| Last Updated: | November 19, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Medicine and Dentistry New Jersey:
|
stage IV prostate cancer stage III prostate cancer recurrent prostate cancer stage IIB prostate cancer stage IIA prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Atorvastatin Celecoxib Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 22, 2013