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| 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 |
| Study Start Date: | February 2002 |
OBJECTIVES:
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.
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 |
DISEASE CHARACTERISTICS:
Must have undergone 1 of the following curative treatment strategies:
Radical prostatectomy
Biochemical failure, meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent CYP2C9 inhibitor or substrates, including but not limited to the following:
Contacts and Locations
Hide Study 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 | |
| Investigator: | Sheron B. Bass, RN, MS | Myriad Pharmaceuticals |
More Information
| 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 |
|
adenocarcinoma of the prostate recurrent prostate cancer |
|
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 |