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R-Flurbiprofen in Treating Patients With Localized Prostate Cancer at Risk of Recurrence
This study is ongoing, but not recruiting participants.
First Received: September 6, 2002   Last Updated: February 6, 2009   History of Changes
Sponsor: Myriad Pharmaceuticals
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00045123
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: R-flurbiprofen
Procedure: adjuvant therapy
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control
Official Title: Phase IIB, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Efficacy of MPC-7869 in Delaying the Systemic Progression of Prostate Cancer in Patients With Intermediate to High Risk of Recurrence With Rising PSA Levels After Prostatectomy, Prostatectomy and Radiotherapy or Radiotherapy Alone for Localized Disease

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2002
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045123

  Hide Study Locations
Locations
United States, Alabama
Urology Centers of Alabama
Homewood, Alabama, United States, 35209
United States, Alaska
Alaska Clinical Research Center, LLC
Anchorage, Alaska, United States, 99508
United States, California
Atlantic Urology Medical Group
Long Beach, California, United States, 90806
Orange County Urology Associates
Laguna Hills, California, United States, 92653
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-7187
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Coastal Medical Research Group, Incorporated
San Luis Obispo, California, United States, 93401
San Diego Urological Medical Group
San Diego, California, United States, 92101
South Orange County Hematology-Oncology Associates
Laguna Hills, California, United States, 92653
Urology Associates Of Central California
Fresno, California, United States, 93720
United States, Colorado
Urology Associates - Research
Denver, Colorado, United States, 80210
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5001
United States, Florida
21st Century Oncology - Fort Myers
Fort Myers, Florida, United States, 33901-8082
Lynn Regional Cancer Center West
Boca Raton, Florida, United States, 33428
South Florida Medical Research
Aventura, Florida, United States, 33180
UroSearch - Ocala
Ocala, Florida, United States, 34471
United States, Georgia
Rice, Lake and Harper Urology, LLC
Columbus, Georgia, United States, 31904
United States, Idaho
North Idaho Urology
Coeur d'Alene, Idaho, United States, 83814
United States, Illinois
Cancer Care Specialists of Central Illinois, S.C. - Decatur
Decatur, Illinois, United States, 62526
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
United States, Indiana
Northeast Indiana Research, LLC
Fort Wayne, Indiana, United States, 46825-1675
United States, Kentucky
Cancer Center at Lexington Clinic
Lexington, Kentucky, United States, 40504
United States, Louisiana
Regional Urology, L.L.C.
Shreveport, Louisiana, United States, 71101
United States, Maryland
Drs. Werner, Murdock and Francis, P.A., Urology Associates
Greenbelt, Maryland, United States, 20770
St. Agnes Cancer Center
Baltimore, Maryland, United States, 21229
United States, Michigan
Lakeside Urology, P.C.
St. Joseph, Michigan, United States, 49085
United States, Missouri
Mallinckrodt Institute of Radiology
St. Louis, Missouri, United States, 63110
United States, Nevada
Las Vegas, Nevada, United States, 89109
United States, New Jersey
Center for Urologic Care
Voorhees, New Jersey, United States, 08043
Lawrenceville Urology
Lawrenceville, New Jersey, United States, 08648
United States, New York
AccuMed Research Associates
Garden City, New York, United States, 11530
Staten Island Urologic Oncology
Staten Island, New York, United States, 10305
Veterans Affairs Medical Center - Albany
Albany, New York, United States, 12208
United States, North Carolina
Urology Center
Greensboro, North Carolina, United States, 27401
United States, Ohio
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267-0589
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5046
Urological Associates, Incorporated
Columbus, Ohio, United States, 43222
United States, Oregon
Oregon Urology Specialists
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Center for Urologic Care
Bryn Mawr, Pennsylvania, United States, 19010
Center of Urologic Care of Berks County
West Reading, Pennsylvania, United States, 19611
Urological Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, United States, 17604
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
University Urological Research Institute
Providence, Rhode Island, United States, 02904
United States, South Carolina
Grand Strand Urology LLP
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
University of Tennessee - Graduate School of Medicine
Knoxville, Tennessee, United States, 37920
Urology Associates
Nashville, Tennessee, United States, 37209
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Urology Associates of North Texas
Arlington, Texas, United States, 76012
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390-9110
Center for Cancer Prevention and Care at Scott and White Clinic
Temple, Texas, United States, 76508
Urology Clinics of North Texas
Dallas, Texas, United States, 75231
Urology Consultants, P.A.
San Antonio, Texas, United States, 78229
United States, Utah
Salt Lake Research
Salt Lake City, Utah, United States, 84124
United States, Vermont
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States, 05405-0075
United States, Washington
Highline Hospital Campus
Seattle, Washington, United States, 98166
Northwest Hospital and Medical Center
Seattle, Washington, United States, 98133
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
Myriad Pharmaceuticals
Investigators
Investigator: Sheron B. Bass, RN, MS Myriad Pharmaceuticals
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000256371, MYRIAD-MPR-7869-001
Study First Received: September 6, 2002
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00045123     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
recurrent prostate cancer

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Disease Attributes
Prostatic Diseases
Genital Neoplasms, Male
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urogenital Neoplasms
Pathologic Processes
Neoplasms by Site
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Genital Diseases, Male
Recurrence
Pharmacologic Actions
Neoplasms
Analgesics, Non-Narcotic
Flurbiprofen
Peripheral Nervous System Agents
Antirheumatic Agents
Prostatic Neoplasms
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 25, 2009