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

Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: R-flurbiprofen (Drug); adjuvant therapy (Procedure)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Myriad Pharmaceuticals

Official(s) and/or principal investigator(s):
Sheron B. Bass, RN, MS, Affiliation: Myriad Pharmaceuticals

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.

Clinical Details

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 design: Treatment, Randomized, Double-Blind, Placebo Control

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

Locations and Contacts

Urology Centers of Alabama, Homewood, Alabama 35209, United States

Alaska Clinical Research Center, LLC, Anchorage, Alaska 99508, United States

Atlantic Urology Medical Group, Long Beach, California 90806, United States

Coastal Medical Research Group, Incorporated, San Luis Obispo, California 93401, United States

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California 90095-7187, United States

Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California 92354, United States

Orange County Urology Associates, Laguna Hills, California 92653, United States

San Diego Urological Medical Group, San Diego, California 92101, United States

South Orange County Hematology-Oncology Associates, Laguna Hills, California 92653, United States

Urology Associates Of Central California, Fresno, California 93720, United States

Urology Associates - Research, Denver, Colorado 80210, United States

Walter Reed Army Medical Center, Washington, District of Columbia 20307-5001, United States

21st Century Oncology - Fort Myers, Fort Myers, Florida 33901-8082, United States

Lynn Regional Cancer Center West, Boca Raton, Florida 33428, United States

South Florida Medical Research, Aventura, Florida 33180, United States

UroSearch - Ocala, Ocala, Florida 34471, United States

Rice, Lake and Harper Urology, LLC, Columbus, Georgia 31904, United States

North Idaho Urology, Coeur d'Alene, Idaho 83814, United States

Cancer Care Specialists of Central Illinois, S.C. - Decatur, Decatur, Illinois 62526, United States

Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois 62526, United States

Evanston Northwestern Health Care - Evanston Hospital, Evanston, Illinois 60201-1781, United States

Northeast Indiana Research, LLC, Fort Wayne, Indiana 46825-1675, United States

Cancer Center at Lexington Clinic, Lexington, Kentucky 40504, United States

Regional Urology, L.L.C., Shreveport, Louisiana 71101, United States

Drs. Werner, Murdock and Francis, P.A., Urology Associates, Greenbelt, Maryland 20770, United States

St. Agnes Cancer Center, Baltimore, Maryland 21229, United States

Lakeside Urology, P.C., St. Joseph, Michigan 49085, United States

Mallinckrodt Institute of Radiology, St. Louis, Missouri 63110, United States

Las Vegas, Nevada 89109, United States

Center for Urologic Care, Voorhees, New Jersey 08043, United States

Lawrenceville Urology, Lawrenceville, New Jersey 08648, United States

AccuMed Research Associates, Garden City, New York 11530, United States

Staten Island Urologic Oncology, Staten Island, New York 10305, United States

Veterans Affairs Medical Center - Albany, Albany, New York 12208, United States

Urology Center, Greensboro, North Carolina 27401, United States

Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio 45267-0589, United States

Ireland Cancer Center, Cleveland, Ohio 44106-5046, United States

Urological Associates, Incorporated, Columbus, Ohio 43222, United States

Oregon Urology Specialists, Eugene, Oregon 97401, United States

Center for Urologic Care, Bryn Mawr, Pennsylvania 19010, United States

Center of Urologic Care of Berks County, West Reading, Pennsylvania 19611, United States

Urological Associates of Lancaster, Ltd., Lancaster, Pennsylvania 17604, United States

Rhode Island Hospital, Providence, Rhode Island 02903, United States

University Urological Research Institute, Providence, Rhode Island 02904, United States

Grand Strand Urology LLP, Myrtle Beach, South Carolina 29572, United States

University of Tennessee - Graduate School of Medicine, Knoxville, Tennessee 37920, United States

Urology Associates, Nashville, Tennessee 37209, United States

Baylor University Medical Center, Dallas, Texas 75246, United States

Center for Cancer Prevention and Care at Scott and White Clinic, Temple, Texas 76508, United States

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas 75390-9110, United States

Urology Associates of North Texas, Arlington, Texas 76012, United States

Urology Clinics of North Texas, Dallas, Texas 75231, United States

Urology Consultants, P.A., San Antonio, Texas 78229, United States

Salt Lake Research, Salt Lake City, Utah 84124, United States

Vermont Cancer Center at University of Vermont, Burlington, Vermont 05405-0075, United States

Highline Hospital Campus, Seattle, Washington 98166, United States

Northwest Hospital and Medical Center, Seattle, Washington 98133, United States

University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin 53715, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: February 2002
Last updated: May 23, 2008

Page last updated: June 20, 2008

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