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Study Of Epoetin Alfa Vs Epoetin Alfa With Dexamethasone In Hormone Refractory Prostate Cancer Patients: Impact On Fatigue, Anemia, Functional Status And Quality Of Life


Phase 3
18 Years
N/A
Not Enrolling
Male
Anemia, Fatigue, Prostate Cancer

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Trial Information

Study Of Epoetin Alfa Vs Epoetin Alfa With Dexamethasone In Hormone Refractory Prostate Cancer Patients: Impact On Fatigue, Anemia, Functional Status And Quality Of Life


OBJECTIVES:

- Compare the effect of epoetin alfa with or without dexamethasone on the level of
cancer-related fatigue measured by the FACIT fatigue subscale, in patients with
hormone-refractory prostate cancer.

- Compare the effect of these regimens on increasing hemoglobin levels in these patients.

- Compare the effect of these regimens on palliation of other disease-related symptoms
and on functional status and overall quality of life of these patients.

- Compare the survival rate of these regimens in these patients.

- Compare the toxicity profile of these regimens in these patients.

- Determine the incidence of adrenal suppression in these patients after receiving
dexamethasone therapy.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to usual
fatigue severity on the Brief Fatigue Inventory numerical scale (3-6 vs 7-10) and hemoglobin
level (8-10 g/dL vs 10.1-11.9 g/dL). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive epoetin alfa subcutaneously once a week.

- Arm II: Patients receive epoetin alfa as in arm I and oral dexamethasone once a day.

In both arms, treatment continues for 12 weeks in the absence of unacceptable toxicity.

Quality of life and fatigue are assessed at baseline and then at 4, 8, and 12 weeks.

Patients are followed for 3 years.

PROJECTED ACCRUAL: A total of 282 patients (141 per treatment arm) will be accrued for this
study within approximately 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed prostate cancer

- Hormone-refractory disease as evidenced by progression on bone scan or CT scan
with a rising prostate-specific antigen

- Prior bilateral orchiectomy OR other primary hormonal therapy (e.g., estrogen therapy
or luteinizing hormone-releasing hormone analog [LHRH] and flutamide) with evidence
of treatment failure

- Concurrent continual LHRH agonist therapy (e.g., depot leuprolide or goserelin)
required for patients who have not undergone bilateral orchiectomy

- Must have anemia with hemoglobin ≥ 8 g/dL and < 12 g/dL within the past 14 days

- Must be iron replete (i.e., ferritin > 50 ng/mL) within the past 30 days

- Presence of fatigue with usual fatigue severity ≥ 3 on the 0-10 numerical scale of
the Brief Fatigue Inventory within the past 14 days

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-3

Life expectancy

- Not specified

Hematopoietic

- See Disease Characteristics

- No disseminated intravascular coagulation

- No autoimmune hemolytic anemia

Hepatic

- AST and ALT ≤ 2 times upper limit of normal

- No prior hemochromatosis or iron intolerance

Renal

- Creatinine < 2.5 mg/dL

Cardiovascular

- Adequate blood pressure (i.e., systolic blood pressure < 140 mm Hg and diastolic
blood pressure < 90 mm Hg) (treated or untreated)

- No history of thromboembolic events

- No unstable angina

- No poorly controlled cardiac disease

Other

- Fertile patients must use effective contraception

- Able to read, understand, and answer questions on the symptom and quality of life
study instruments

- No ongoing chronic hemorrhage (e.g., gross hematuria due to advanced prostate
cancer)* NOTE: *Microscopic hematuria allowed

- No acute or subacute illness that may require transfusion

- No gastrointestinal bleeding

- No active systemic infection

- No known or suspected hypersensitivity to human albumin

- No known or suspected hypersensitivity to mammalian cell-derived products

- No uncontrolled diabetes

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 30 days since prior epoetin alfa

Chemotherapy

- More than 21 days since prior chemotherapy

- No more than 2 different types of prior chemotherapy regimens for hormone-refractory
prostate cancer

Endocrine therapy

- See Disease Characteristics

- More than 30 days since prior corticosteroids for hormone-refractory prostate cancer

- Episodic use of low-dose steroids for other causes is allowed

Radiotherapy

- More than 21 days since prior radiotherapy

- Concurrent radiotherapy allowed

Surgery

- See Disease Characteristics

Other

- More than 8 weeks since prior blood transfusion

- No concurrent oral or intravenous antibiotics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Outcome Measure:

Fatigue response as measured by the Functional Assessment of Chronic Illness Therapy Fatigue Subscale

Principal Investigator

Shirley S. Hwang, RN, MS

Investigator Role:

Study Chair

Investigator Affiliation:

Veterans Affairs Medical Center - East Orange

Authority:

United States: Federal Government

Study ID:

CDR0000301881

NCT ID:

NCT00060398

Start Date:

June 2004

Completion Date:

Related Keywords:

  • Anemia
  • Fatigue
  • Prostate Cancer
  • recurrent prostate cancer
  • anemia
  • fatigue
  • Anemia
  • Fatigue
  • Prostatic Neoplasms

Name

Location

CCOP - WichitaWichita, Kansas  67214-3882
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
Aurora Presbyterian HospitalAurora, Colorado  80012
Boulder Community HospitalBoulder, Colorado  80301-9019
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
Sky Ridge Medical CenterLone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United HospitalLongmont, Colorado  80502
North Suburban Medical CenterThornton, Colorado  80229
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Foote HospitalJackson, Michigan  49201
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
Seton Cancer Institute - SaginawSaginaw, Michigan  48601
St. John Macomb HospitalWarren, Michigan  48093
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
CCOP - DuluthDuluth, Minnesota  55805
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
CCOP - MeritCare HospitalFargo, North Dakota  58122
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
CCOP - ColumbusColumbus, Ohio  43206
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
CCOP - Scott and White HospitalTemple, Texas  76508
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
CCOP - Colorado Cancer Research Program, IncorporatedDenver, Colorado  80224
Tufts - New England Medical CenterBoston, Massachusetts  02111
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Aultman Hospital Cancer Center at Aultman Health FoundationCanton, Ohio  44710-1799
St. Mary's - Duluth Clinic Cancer CenterDuluth, Minnesota  55805
Our Lady of Mercy Medical Center Comprehensive Cancer CenterBronx, New York  10466
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Cancer Center of Kansas, P.A. - El DoradoEl Dorado, Kansas  67042
Southwest Medical CenterLiberal, Kansas  67901
Cancer Center of Kansas, P.A. - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, P.A. - WichitaWichita, Kansas  67214
Fox Chase Virtua Health Cancer Program - MarltonMarlton, New Jersey  08053
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grant Riverside Cancer ServicesColumbus, Ohio  43215
Mount Carmel West HospitalColumbus, Ohio  43222
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Mount Carmel Cancer Services at Mount Carmel St. Ann's HospitalWesterville, Ohio  43081
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Memorial Medical Center Cancer ServicesModesto, California  95355
St. Mary-Corwin Regional Medical CenterPueblo, Colorado  81004
Swedish Covenant HospitalChicago, Illinois  60625
Mercy Hospital and Medical CenterChicago, Illinois  60616
Hematology and Oncology AssociatesChicago, Illinois  60611
Midwest Center for Hematology/OncologyJoliet, Illinois  60432
North Shore Oncology and Hematology Associates, Limited - LibertyvilleLibertyville, Illinois  60048
Northwest Medical Specialist, PCNiles, Illinois  60714
Midwest Cancer Research Group, IncorporatedSkokie, Illinois  60077
Hematology/Oncology of the North Shore at Gross Point Medical CenterSkokie, Illinois  60076
McFarland Clinic, P. C.Ames, Iowa  50010
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Cancer Center of Kansas, P.A. - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas, P.A. - KingmanKingman, Kansas  67068
Cancer Center of Kansas, P.A. - NewtonNewton, Kansas  67114
Cancer Center of Kansas, P.A. - PrattPratt, Kansas  67124
Cancer Center of Kansas, P.A. - SalinaSalina, Kansas  67042
Cancer Center of Kansas, P.A. - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, P.A. - Medical Arts TowerWichita, Kansas  67208
Associates in Womens Health, P.A. - North ReviewWichita, Kansas  67203
Cancer Center of Kansas, P.A. - WinfieldWinfield, Kansas  67156
Pennington Cancer Center at Baton Rouge GeneralBaton Rouge, Louisiana  70806
Mary Bird Perkins Cancer Center - Baton RougeBaton Rouge, Louisiana  70809
Medical Center of Louisiana - New OrleansNew Orleans, Louisiana  70112
St. Joseph Mercy Cancer Center at St. Joseph Mercy HospitalAnn Arbor, Michigan  48106-0995
MeritCare Clinic - BemidjiBemidji, Minnesota  56601
Virginia Piper Cancer Institute at Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Medical CenterRobbinsdale, Minnesota  55422-2900
Park Nicollet Health ServicesSt. Louis Park, Minnesota  55416
MeritCare Medical GroupFargo, North Dakota  58122
Mercy Medical CenterSpringfield, Ohio  45504
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Green Bay Oncology, Limited at St. Vincent HospitalGreen Bay, Wisconsin  54301-3526
Dean Medical Center - Fish HatcheryMadison, Wisconsin  53715
Holy Family Memorial Medical Center Cancer Care CenterManitowoc, Wisconsin  54221-1450
St. Anthony's Memorial HospitalEffingham, Illinois  62401
Miller-Dwan Medical CenterDuluth, Minnesota  55805
Geisinger Medical GroupState College, Pennsylvania  16801
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
MBCCOP - Meharry Medical College - NashvilleNashville, Tennessee  37208-3599
Shore Memorial Hospital - Somers PointSomers Point, New Jersey  08244
Elmhurst Memorial HospitalElmhurst, Illinois  60126
Lawrence Memorial Hospital of MedfordMedford, Massachusetts  02155
Commonwealth Hematology-Oncology P. C. - QuincyQuincy, Massachusetts  02169