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

NCT01220973 | Completed Phase 2 Results

• 3 other identifiers: 0220090006, 0808110220090006NCI-2012-00540
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 4

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.

Conditions

Prostate Cancer

Keywords

stage IV prostate cancer; stage III prostate cancer; recurrent prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer

Outcome Measures

Primary Outcomes (1)

• PSA Response

  PSA response was defined as a decrease in slope of at least 25%, when log (PSA) is plotted vs. time.

  6 months

Study Arms (1)

Atorvastatin and Celecoxib

EXPERIMENTAL

Drug: atorvastatin calcium; Drug: celecoxib; Other: laboratory biomarker analysis

Interventions

atorvastatin calcium DRUG

Atorvastatin and Celecoxib

celecoxib DRUG

Atorvastatin and Celecoxib

laboratory biomarker analysis OTHER

Atorvastatin and Celecoxib

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Rutgers Cancer Institute of New Jersey: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Karmanos Cancer Center

Detroit, Michigan, 48201, United States

Location

Cooper Hospital

Camden, New Jersey, 08103, United States

Location

Robert Wood Johnson University Hospital at Hamilton

Hamilton, New Jersey, 08690, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Atorvastatin; Celecoxib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles

Results Point of Contact

• Title: Susan Goodin PharmD, FCCP, BCOP
• Organization: Rutgers Cancer Institute of New Jersey

goodin@cinj.rutgers.edu

732-235-6783

Study Officials

• Susan Goodin, PhD, FCCP, BCOP

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, RWJMS

Study Record Dates

• First Submitted: October 13, 2010
• First Posted: October 14, 2010
• Study Start: February 1, 2009
• Primary Completion: November 18, 2014
• Study Completion: November 18, 2014
• Last Updated: June 8, 2018
• Results First Posted: April 20, 2018

Record last verified: 2018-05

Locations

US (4)