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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
tarenflurbil
adjuvant therapy
Sponsored by
Myrexis Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Urology Centers of Alabama
  • Alaska Clinical Research Center, LLC
  • Urology Associates Of Central California
  • Orange County Urology Associates
  • South Orange County Hematology-Oncology Associates
  • Loma Linda University Cancer Institute at Loma Linda University Medical Center
  • Atlantic Urology Medical Group
  • Jonsson Comprehensive Cancer Center, UCLA
  • San Diego Urological Medical Group
  • Coastal Medical Research Group, Incorporated
  • Urology Associates - Research
  • Walter Reed Army Medical Center
  • South Florida Medical Research
  • Lynn Regional Cancer Center West
  • 21st Century Oncology - Fort Myers
  • UroSearch - Ocala
  • Rice, Lake and Harper Urology, LLC
  • North Idaho Urology
  • Cancer Care Specialists of Central Illinois, S.C. - Decatur
  • Decatur Memorial Hospital Cancer Care Institute
  • Evanston Northwestern Health Care - Evanston Hospital
  • Northeast Indiana Research, LLC
  • Cancer Center at Lexington Clinic
  • Regional Urology, L.L.C.
  • St. Agnes Cancer Center
  • Drs. Werner, Murdock and Francis, P.A., Urology Associates
  • Lakeside Urology, P.C.
  • Mallinckrodt Institute of Radiology
  • Lawrenceville Urology
  • Center for Urologic Care
  • Veterans Affairs Medical Center - Albany
  • AccuMed Research Associates
  • Staten Island Urologic Oncology
  • Urology Center
  • Charles M. Barrett Cancer Center at University Hospital
  • Ireland Cancer Center
  • Urological Associates, Incorporated
  • Oregon Urology Specialists
  • Center for Urologic Care
  • Urological Associates of Lancaster, Ltd.
  • Center of Urologic Care of Berks County
  • Rhode Island Hospital
  • University Urological Research Institute
  • Grand Strand Urology LLP
  • University of Tennessee - Graduate School of Medicine
  • Urology Associates
  • Urology Associates of North Texas
  • Urology Clinics of North Texas
  • Baylor University Medical Center
  • Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
  • Urology Consultants, P.A.
  • Center for Cancer Prevention and Care at Scott and White Clinic
  • Salt Lake Research
  • Vermont Cancer Center at University of Vermont
  • Northwest Hospital and Medical Center
  • Highline Hospital Campus
  • University of Wisconsin Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 6, 2002
Last Updated
December 17, 2013
Sponsor
Myrexis Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00045123
Brief Title
R-Flurbiprofen in Treating Patients With Localized Prostate Cancer at Risk of Recurrence
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 Type
Interventional

2. Study Status

Record Verification Date
February 2004
Overall Recruitment Status
Unknown status
Study Start Date
February 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Myrexis Inc.

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
tarenflurbil
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheron B. Bass, RN, MS
Organizational Affiliation
Myrexis Inc.
Facility Information:
Facility Name
Urology Centers of Alabama
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Alaska Clinical Research Center, LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Urology Associates Of Central California
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Orange County Urology Associates
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
South Orange County Hematology-Oncology Associates
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Loma Linda University Cancer Institute at Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Atlantic Urology Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-7187
Country
United States
Facility Name
San Diego Urological Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
Coastal Medical Research Group, Incorporated
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93401
Country
United States
Facility Name
Urology Associates - Research
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5001
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Lynn Regional Cancer Center West
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Facility Name
21st Century Oncology - Fort Myers
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901-8082
Country
United States
Facility Name
UroSearch - Ocala
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Rice, Lake and Harper Urology, LLC
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
North Idaho Urology
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Cancer Care Specialists of Central Illinois, S.C. - Decatur
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Decatur Memorial Hospital Cancer Care Institute
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Evanston Northwestern Health Care - Evanston Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201-1781
Country
United States
Facility Name
Northeast Indiana Research, LLC
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825-1675
Country
United States
Facility Name
Cancer Center at Lexington Clinic
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Regional Urology, L.L.C.
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
St. Agnes Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Drs. Werner, Murdock and Francis, P.A., Urology Associates
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
Facility Name
Lakeside Urology, P.C.
City
St. Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Mallinckrodt Institute of Radiology
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Lawrenceville Urology
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Center for Urologic Care
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Veterans Affairs Medical Center - Albany
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
AccuMed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Staten Island Urologic Oncology
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Urology Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Charles M. Barrett Cancer Center at University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0589
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5046
Country
United States
Facility Name
Urological Associates, Incorporated
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Oregon Urology Specialists
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Center for Urologic Care
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Urological Associates of Lancaster, Ltd.
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Center of Urologic Care of Berks County
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
University Urological Research Institute
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States
Facility Name
Grand Strand Urology LLP
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
University of Tennessee - Graduate School of Medicine
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Urology Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Facility Name
Urology Associates of North Texas
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Urology Clinics of North Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9110
Country
United States
Facility Name
Urology Consultants, P.A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Center for Cancer Prevention and Care at Scott and White Clinic
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Salt Lake Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Vermont Cancer Center at University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405-0075
Country
United States
Facility Name
Northwest Hospital and Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
Highline Hospital Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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