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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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Sheron B. Bass, RN, MS

Investigator Affiliation:

Myrexis Inc.

Authority:

United States: Federal Government

Study ID:

CDR0000256371

NCT ID:

NCT00045123

Start Date:

February 2002

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • Prostatic Neoplasms
  • Recurrence

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
Ireland Cancer CenterCleveland, Ohio  44106-5065
Rhode Island HospitalProvidence, Rhode Island  02903
Mallinckrodt Institute of RadiologySaint Louis, Missouri  63110
Veterans Affairs Medical Center - AlbanyAlbany, New York  12208
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Evanston Northwestern Health Care - Evanston HospitalEvanston, Illinois  60201
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354
21st Century Oncology - Fort MyersFort Myers, Florida  33901-8082
Cancer Center at Lexington ClinicLexington, Kentucky  40504
St. Agnes Cancer CenterBaltimore, Maryland  21229
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075
Simmons Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390-9063
Center for Cancer Prevention and Care at Scott and White ClinicTemple, Texas  76508
Baylor University Medical CenterDallas, Texas  75246
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Urology Associates of North TexasArlington, Texas  76015
Urology Clinics of North TexasDallas, Texas  75231
Lynn Regional Cancer Center WestBoca Raton, Florida  33428
South Florida Medical ResearchAventura, Florida  33180
North Idaho UrologyCouer D'Alene, Idaho  83814
San Diego Urological Medical GroupSan Diego, California  92101
Lakeside Urology, P.C.St. Joseph, Michigan  49085-2521
Center for Urologic CareWest Reading, Pennsylvania  19611
Urology Consultants, P.A.San Antonio, Texas  78229
Alaska Clinical Research Center, LLCAnchorage, Alaska  99508
AccuMed Research AssociatesGarden City, New York  11530
Urology Centers Of AlabamaHomewood,, Alabama  35205
Oregon Urology SpecialistsEugene, Oregon  97401
Urology AssociatesNashville, Tennessee  37209
Salt Lake ResearchSalt Lake City, Utah  84124
Urology Associates Of Central CaliforniaFresno, California  93720
Orange County Urology AssociatesLaguna Hills, California  92653
South Orange County Hematology-Oncology AssociatesLaguna Hills, California  92653
Atlantic Urology Medical GroupLong Beach, California  90806
Coastal Medical Research Group, IncorporatedSan Luis Obispo, California  93401
Urology Associates - ResearchDenver, Colorado  80210
UroSearch - OcalaOcala, Florida  34471
Rice, Lake and Harper Urology, LLCColumbus, Georgia  31904
Cancer Care Specialists of Central Illinois, S.C. - DecaturDecatur, Illinois  62526
Northeast Indiana Research, LLCFort Wayne, Indiana  46825-1675
Regional Urology, L.L.C.Shreveport, Louisiana  71101
Drs. Werner, Murdock and Francis, P.A., Urology AssociatesGreenbelt, Maryland  20770
Las Vegas, Nevada  89109
Lawrenceville UrologyLawrenceville, New Jersey  08648
Center for Urologic CareVoorhees, New Jersey  08043
Staten Island Urologic OncologyStaten Island, New York  10305
Urology CenterGreensboro, North Carolina  27401
Urological Associates, IncorporatedColumbus, Ohio  43222
Urological Associates of Lancaster, Ltd.Lancaster, Pennsylvania  17604
Center of Urologic Care of Berks CountyWest Reading, Pennsylvania  19611
University Urological Research InstituteProvidence, Rhode Island  02904
Grand Strand Urology LLPMyrtle Beach, South Carolina  29572
University of Tennessee - Graduate School of MedicineKnoxville, Tennessee  37920
Highline Hospital CampusSeattle, Washington  98166
Northwest Hospital and Medical CenterSeattle, Washington  98133