R-Flurbiprofen in Treating Patients With Localized Prostate Cancer at Risk of Recurrence

NCT00045123 | Unknown Phase 2

• 2 other identifiers: CDR0000256371MYRIAD-MPR-7869-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 58

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. R-flurbiprofen may be effective in delaying the recurrence of localized prostate cancer. PURPOSE: Randomized phase II trial to study the effectiveness of R-flurbiprofen in treating patients who have localized prostate cancer at risk of recurrence following radiation therapy and/or prostatectomy.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer

Interventions

tarenflurbil DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed localized adenocarcinoma of the prostate (from a pre-operative core biopsy, surgical specimen, or post-therapy core biopsy) * Gleason score 5-10 at diagnosis (the highest score is used if multiple scores are available) * Must have undergone 1 of the following curative treatment strategies: * Radical prostatectomy * Not a candidate for radiotherapy * Radical prostatectomy followed by radiotherapy at the time of surgery or any time thereafter * Radiotherapy of the prostate and/or surrounding structures by external beam radiotherapy (EBRT), brachytherapy (BT), or a combination of EBRT and BT * Must have 3 consecutive rising prostate-specific antigen (PSA) measurements OR meets slope criteria * Biochemical failure, meeting 1 of the following criteria: * PSA at least 0.2 ng/mL post radical prostatectomy * PSA greater than 1.5 ng/mL after radiotherapy or appropriate calculated slope * Testosterone at least 100 ng/mL * No rise in PSA with concurrent clinically active prostatitis * No metastatic prostate cancer * PSA no greater than 20.0 ng/mL PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * Not specified Hematopoietic * WBC at least 2,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic * Bilirubin no greater than 1.5 mg/dL * AST or ALT no greater than 2 times upper limit of normal Renal * Creatinine no greater than 2.0 mg/dL Cardiovascular * No uncontrolled cardiac conditions * No New York Heart Association class III or IV heart disease Gastrointestinal * No active ulcer disease diagnosed within the past 3 months * No upper gastrointestinal bleed requiring a transfusion within the past 3 years * No non-steroidal anti-inflammatory drug (NSAID)-associated ulcers within the past 5 years Other * No known hypersensitivity to NSAIDs, including COX-2-specific inhibitors (e.g., celecoxib or rofecoxib) * No other malignancy within the past 5 years except basal cell or squamous cell skin cancer * No active systemic infections * No other serious uncontrolled medical condition * No dementia or altered mental status PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent biologic therapy Chemotherapy * More than 5 years since prior cytotoxic chemotherapy for other malignant disease * No prior cytotoxic chemotherapy for prostate cancer * No concurrent chemotherapy Endocrine therapy * More than 9 months since prior androgen-deprivation therapy other than as cytoreductive therapy (neoadjuvantly or adjuvantly for less than 9 months) with the intent to cure * More than 3 months since prior cyproterone, finasteride, diethylstilbestrol, megestrol, or other hormonally active (antiandrogen or antiprostate) therapies Radiotherapy * See Disease Characteristics * No prior strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium, or other radioisotope materials for palliative intent or metastasis intervention * Concurrent iodine I 125 or palladium Pd 103 for primary brachytherapy with curative intent allowed Surgery * See Disease Characteristics * More than 8 weeks since prior major surgery and recovered * No prior orchiectomy Other * More than 1 month since prior PC-SPES * More than 1 month since prior investigational agents or devices (6 months for other investigational therapy for prostate cancer) * No prior bisphosphonates (e.g., pamidronate, alendronate, or clodronate) for palliative intent or metastasis intervention * At least 2 months since prior chronic non-steroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (COX-2)-specific inhibitors (e.g., celecoxib or rofecoxib), administered for more than 7 days per month * No concurrent CYP2C9 inhibitor or substrates, including but not limited to the following: * Phenytoin * Fluvastatin * Amiodarone * Fluconazole * Acenocoumarol * Diclofenac * No concurrent ketoconazole * No concurrent antiretroviral therapy for HIV-positive patients * Concurrent cardioprotective aspirin up to 100 mg once daily allowed

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

Sponsors & Collaborators

• Myrexis Inc.: lead

Study Sites (58)

Urology Centers of Alabama

Homewood, Alabama, 35209, United States

Location

Alaska Clinical Research Center, LLC

Anchorage, Alaska, 99508, United States

Location

Urology Associates Of Central California

Fresno, California, 93720, United States

Location

Orange County Urology Associates

Laguna Hills, California, 92653, United States

Location

South Orange County Hematology-Oncology Associates

Laguna Hills, California, 92653, United States

Location

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Atlantic Urology Medical Group

Long Beach, California, 90806, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-7187, United States

Location

San Diego Urological Medical Group

San Diego, California, 92101, United States

Location

Coastal Medical Research Group, Incorporated

San Luis Obispo, California, 93401, United States

Location

Urology Associates - Research

Denver, Colorado, 80210, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5001, United States

Location

South Florida Medical Research

Aventura, Florida, 33180, United States

Location

Lynn Regional Cancer Center West

Boca Raton, Florida, 33428, United States

Location

21st Century Oncology - Fort Myers

Fort Myers, Florida, 33901-8082, United States

Location

UroSearch - Ocala

Ocala, Florida, 34471, United States

Location

Rice, Lake and Harper Urology, LLC

Columbus, Georgia, 31904, United States

Location

North Idaho Urology

Coeur d'Alene, Idaho, 83814, United States

Location

Cancer Care Specialists of Central Illinois, S.C. - Decatur

Decatur, Illinois, 62526, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Evanston Northwestern Health Care - Evanston Hospital

Evanston, Illinois, 60201-1781, United States

Location

Northeast Indiana Research, LLC

Fort Wayne, Indiana, 46825-1675, United States

Location

Cancer Center at Lexington Clinic

Lexington, Kentucky, 40504, United States

Location

Regional Urology, L.L.C.

Shreveport, Louisiana, 71101, United States

Location

St. Agnes Cancer Center

Baltimore, Maryland, 21229, United States

Location

Drs. Werner, Murdock and Francis, P.A., Urology Associates

Greenbelt, Maryland, 20770, United States

Location

Lakeside Urology, P.C.

Saint Joseph, Michigan, 49085, United States

Location

Mallinckrodt Institute of Radiology

St Louis, Missouri, 63110, United States

Location

Unknown Facility

Las Vegas, Nevada, 89109, United States

Location

Lawrenceville Urology

Lawrenceville, New Jersey, 08648, United States

Location

Center for Urologic Care

Voorhees Township, New Jersey, 08043, United States

Location

Veterans Affairs Medical Center - Albany

Albany, New York, 12208, United States

Location

AccuMed Research Associates

Garden City, New York, 11530, United States

Location

Staten Island Urologic Oncology

Staten Island, New York, 10305, United States

Location

Urology Center

Greensboro, North Carolina, 27401, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267-0589, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5046, United States

Location

Urological Associates, Incorporated

Columbus, Ohio, 43222, United States

Location

Oregon Urology Specialists

Eugene, Oregon, 97401, United States

Location

Center for Urologic Care

Bryn Mawr, Pennsylvania, 19010, United States

Location

Urological Associates of Lancaster, Ltd.

Lancaster, Pennsylvania, 17604, United States

Location

Center of Urologic Care of Berks County

West Reading, Pennsylvania, 19611, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

University Urological Research Institute

Providence, Rhode Island, 02904, United States

Location

Grand Strand Urology LLP

Myrtle Beach, South Carolina, 29572, United States

Location

University of Tennessee - Graduate School of Medicine

Knoxville, Tennessee, 37920, United States

Location

Urology Associates

Nashville, Tennessee, 37209, United States

Location

Urology Associates of North Texas

Arlington, Texas, 76012, United States

Location

Urology Clinics of North Texas

Dallas, Texas, 75231, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390-9110, United States

Location

Urology Consultants, P.A.

San Antonio, Texas, 78229, United States

Location

Center for Cancer Prevention and Care at Scott and White Clinic

Temple, Texas, 76508, United States

Location

Salt Lake Research

Salt Lake City, Utah, 84124, United States

Location

Vermont Cancer Center at University of Vermont

Burlington, Vermont, 05405-0075, United States

Location

Northwest Hospital and Medical Center

Seattle, Washington, 98133, United States

Location

Highline Hospital Campus

Seattle, Washington, 98166, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

tarenflurbil; Chemotherapy, Adjuvant

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)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Sheron B. Bass, RN, MS

  Myrexis Inc.

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 6, 2002
• First Posted: February 6, 2003
• Study Start: February 1, 2002
• Last Updated: December 18, 2013

Record last verified: 2004-02

Locations

US (58)