R-Flurbiprofen in Treating Patients With Localized Prostate Cancer at Risk of Recurrence
NCT ID: NCT00045123
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
INTERVENTIONAL
2002-02-28
Brief Summary
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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.
Detailed Description
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* Determine the effect of R-flurbiprofen on time to systemic disease progression evaluated over a minimum of 3 years in patients with localized adenocarcinoma of the prostate with an intermediate or high risk of recurrence and rising prostate-specific antigen (PSA) levels after radiotherapy alone, prostatectomy alone, or both radiotherapy and prostatectomy.
* Determine the effect of this drug on the change in serum PSA levels over time prior to androgen-deprivation therapy (ADT) in these patients.
* Determine the effect of this drug on the time of initiation of ADT in these patients.
* Determine the effect of this drug on the number of patients requiring ADT.
* Determine the safety of this drug in these patients.
* Determine the population pharmacokinetics of R-flurbiprofen and bioinversion of R-ToS in this patient population.
* Determine the number of patients with systemic disease progression at the end of the study.
* Determine the time to clinical disease progression in patients treated with this drug.
* Determine the time to prostate cancer-related mortality and time to all cause mortality in patients treated with this drug.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to risk of recurrence based on Gleason score at diagnosis (5-7 vs 8-10). Patients are randomized to 1 of 3 treatment arms.
* Arm I: Patients receive oral low-dose R-flurbiprofen twice daily.
* Arm II: Patients receive oral high-dose R-flurbiprofen twice daily.
* Arm III: Patients receive oral placebo twice daily. In all arms, treatment continues for up to 5.5 years (66 months) in the absence of disease progression or unacceptable toxicity. Patients who demonstrate increased prostate-specific antigen without objective disease progression and require androgen-deprivation therapy (ADT) continue receiving R-flurbiprofen. Patients who develop local recurrence or systemic disease may withdraw from study and receive additional therapy off study.
PROJECTED ACCRUAL: Approximately 390 patients (130 per treatment arm) will be accrued for this study within 3 years.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Interventions
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tarenflurbil
adjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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Myrexis Inc.
INDUSTRY
Principal Investigators
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Sheron B. Bass, RN, MS
Role:
Myrexis Inc.
Locations
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Urology Centers of Alabama
Homewood, Alabama, United States
Alaska Clinical Research Center, LLC
Anchorage, Alaska, United States
Urology Associates Of Central California
Fresno, California, United States
Orange County Urology Associates
Laguna Hills, California, United States
South Orange County Hematology-Oncology Associates
Laguna Hills, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States
Atlantic Urology Medical Group
Long Beach, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
San Diego Urological Medical Group
San Diego, California, United States
Coastal Medical Research Group, Incorporated
San Luis Obispo, California, United States
Urology Associates - Research
Denver, Colorado, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
South Florida Medical Research
Aventura, Florida, United States
Lynn Regional Cancer Center West
Boca Raton, Florida, United States
21st Century Oncology - Fort Myers
Fort Myers, Florida, United States
UroSearch - Ocala
Ocala, Florida, United States
Rice, Lake and Harper Urology, LLC
Columbus, Georgia, United States
North Idaho Urology
Coeur d'Alene, Idaho, United States
Cancer Care Specialists of Central Illinois, S.C. - Decatur
Decatur, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, United States
Northeast Indiana Research, LLC
Fort Wayne, Indiana, United States
Cancer Center at Lexington Clinic
Lexington, Kentucky, United States
Regional Urology, L.L.C.
Shreveport, Louisiana, United States
St. Agnes Cancer Center
Baltimore, Maryland, United States
Drs. Werner, Murdock and Francis, P.A., Urology Associates
Greenbelt, Maryland, United States
Lakeside Urology, P.C.
Saint Joseph, Michigan, United States
Mallinckrodt Institute of Radiology
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Lawrenceville Urology
Lawrenceville, New Jersey, United States
Center for Urologic Care
Voorhees Township, New Jersey, United States
Veterans Affairs Medical Center - Albany
Albany, New York, United States
AccuMed Research Associates
Garden City, New York, United States
Staten Island Urologic Oncology
Staten Island, New York, United States
Urology Center
Greensboro, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Urological Associates, Incorporated
Columbus, Ohio, United States
Oregon Urology Specialists
Eugene, Oregon, United States
Center for Urologic Care
Bryn Mawr, Pennsylvania, United States
Urological Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, United States
Center of Urologic Care of Berks County
West Reading, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
University Urological Research Institute
Providence, Rhode Island, United States
Grand Strand Urology LLP
Myrtle Beach, South Carolina, United States
University of Tennessee - Graduate School of Medicine
Knoxville, Tennessee, United States
Urology Associates
Nashville, Tennessee, United States
Urology Associates of North Texas
Arlington, Texas, United States
Urology Clinics of North Texas
Dallas, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Urology Consultants, P.A.
San Antonio, Texas, United States
Center for Cancer Prevention and Care at Scott and White Clinic
Temple, Texas, United States
Salt Lake Research
Salt Lake City, Utah, United States
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States
Northwest Hospital and Medical Center
Seattle, Washington, United States
Highline Hospital Campus
Seattle, Washington, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Countries
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Other Identifiers
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MYRIAD-MPR-7869-001
Identifier Type: -
Identifier Source: secondary_id
CDR0000256371
Identifier Type: -
Identifier Source: org_study_id
NCT00043251
Identifier Type: -
Identifier Source: nct_alias