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

NCT ID: NCT01220973

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2014-11-18

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Atorvastatin and Celecoxib

Group Type: EXPERIMENTAL

atorvastatin calcium

Intervention Type: DRUG

celecoxib

Intervention Type: DRUG

laboratory biomarker analysis

Intervention Type: OTHER

Interventions

atorvastatin calcium

Intervention Type: DRUG

celecoxib

Intervention Type: DRUG

laboratory biomarker analysis

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Rutgers Cancer Institute of New Jersey

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Susan Goodin, PharmD

Professor of Medicine, RWJMS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Goodin, PhD, FCCP, BCOP

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

Karmanos Cancer Center

Detroit, Michigan, United States

Cooper Hospital

Camden, New Jersey, United States

Robert Wood Johnson University Hospital at Hamilton

Hamilton, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Countries

United States

Other Identifiers

0220090006

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2012-00540

Identifier Type: OTHER

Identifier Source: secondary_id

0220090006, 080811

Identifier Type: -

Identifier Source: org_study_id