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

Prostate Cancer Clinical Trial

Official title:

Phase II Trial of Atorvastatin and Celecoxib in Patients With Hormone-Dependent Prostate-Specific Antigen Progression After Local Therapy for Prostate Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220973
• Other study ID #: 0220090006, 080811
• Secondary ID: 0220090006NCI-20
• Status: Completed
• Phase: Phase 2
• Start date: February 2009
• Est. completion date: November 18, 2014

Study information

• Verified date: May 2018
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 18, 2014
• Est. primary completion date: November 18, 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• atorvastatin calcium

• celecoxib

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
United States	Cooper Hospital	Camden	New Jersey
United States	Karmanos Cancer Center	Detroit	Michigan
United States	Robert Wood Johnson University Hospital at Hamilton	Hamilton	New Jersey
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA Response	PSA response was defined as a decrease in slope of at least 25%, when log (PSA) is plotted vs. time.	6 months