AzTrials
AzTrials

Metastatic CancerPhase 3NCT00134056

S0421, Docetaxel and Prednisone With or Without Atrasentan in Treating Patients With Stage IV Prostate Cancer and Bone Metastases That Did Not Respond to Previous Hormone Therapy

A Phase 3 study testing atrasentan hydrochloride, docetaxel and prednisone in people with Metastatic Cancer and Prostate Cancer, run by SWOG Cancer Research Network at 554 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, prednisone, and atrasentan work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Metastatic Cancer, Prostate Cancer
What is being tested?
atrasentan hydrochloride, docetaxel and prednisone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,038 participants
Where
554 sitesUnited States
Study dates
Aug 2006to Feb 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate
  • Stage IV disease (any T, any N, M1b)
  • Evidence of bone metastases by bone scan or MRI
  • Measurable or nonmeasurable disease
  • Soft tissue disease that has been irradiated within the past 2 months is not assessable as measurable disease
  • Hormone-refractory disease despite androgen deprivation and antiandrogen withdrawal, as defined by 1 of the following criteria:
  • Prostate-specific antigen (PSA) progression, defined as 3 consecutive rising PSA levels* taken ≥ 1 week apart
  • PSA ≥ 5 ng/mL NOTE: *If the third confirmatory PSA level is < the second level, the patient is considered eligible provided a fourth PSA level is > the second level
  • Progression of measurable disease
  • Progression of nonmeasurable disease by bone scan
  • Must have undergone surgical or medical (e.g., luteinizing hormone-releasing hormone [LHRH] agonist [e.g., leuprolide or goserelin] or LHRH antagonist therapy) castration
  • Patients who have undergone medical castration must continue LHRH agonist or antagonist therapy during study treatment
  • Must have completed 12 courses of blinding protocol treatment (atrasentan/placebo) AND stopped docetaxel for any reason (including completion of 12 courses) other than progressive disease
  • No symptomatic pleural effusion
  • No third space fluid accumulation (e.g., ascites)
  • No prior or concurrent brain metastases
  • Patients with clinical evidence of brain metastases must have a negative brain CT scan or MRI within the past 8 weeks

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-3* NOTE: For a performance status of 3, the cause must be due to pain secondary to bone metastases

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Fertile patients must use effective contraception
  • Able to take oral medication without crushing, dissolving, or chewing tablets
  • No major infection
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer in complete remission
  • No symptomatic sensory neuropathy ≥ grade 2
  • No history of hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • No other significant, active medical illness that would preclude study treatment or survival

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No more than 1 prior systemic vaccine or biologic therapy
  • At least 4 weeks since prior vaccine or biologic therapy and recovered
  • No concurrent biological response modifiers
  • No concurrent prophylactic colony-stimulating factors

Chemotherapy

  • More than 2 years since prior adjuvant therapy with a single non-taxane-containing cytotoxic regimen
  • No prior cytotoxic chemotherapy for metastatic prostate cancer
  • No other concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • At least 6 weeks since prior bicalutamide or nilutamide AND has subsequent disease progression
  • At least 4 weeks since prior flutamide or ketoconazole AND has subsequent disease progression
  • Prior or concurrent megestrol for treatment of hot flashes allowed
  • No other concurrent corticosteroid or hormonal therapy unless continuing luteinizing hormone-releasing hormone treatment and/or bisphosphonate therapy

Radiotherapy

  • See Disease Characteristics
  • Prior samarium allowed
  • At least 3 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to ≥ 30% of the bone marrow
  • No prior strontium
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics
  • At least 3 weeks since prior surgery and recovered

Other

  • More than 4 weeks since prior investigational drugs
  • Concurrent bisphosphonates allowed provided therapy is started prior to study entry, dose is maintained during the first 12 weeks of study treatment, and patient meets criteria for disease progression
  • No initiation of bisphosphonates during the first 12 weeks of study treatment
  • No concurrent herbal medications or food supplements (e.g., PC-SPES, saw palmetto, Hypericum perforatum [St. John's wort])
  • Concurrent daily vitamins and calcium supplements allowed
  • At least 14 days since prior and no concurrent administration of any of the following:
  • Antibiotics (e.g., clarithromycin, erythromycin, troleandomycin, rifampin, rifabutin, and rifapentine)
  • Antifungals (e.g., itraconazole, ketoconazole, fluconazole [doses > 200 mg/day], and voriconazole)
  • Antidepressants (e.g., nefazodone and fluvoxamine)
  • Calcium channel blockers (e.g., verapamil, diltiazem)
  • Miscellaneous (e.g., amiodarone [no use within 6 months prior to study entry], grapefruit juice, bitter orange, or modafinil)
  • Anticonvulsants (e.g., phenytoin, carbamazepine, phenobarbital, and oxcarbazepine)
  • Antibiotics (e.g., rifampin, rifabutin, and rifapentine)

Trial locations and contacts

554 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Kapiolani Medical Center at Pali Momi

    ‘Aiea, Hawaii, 96701

  • Oncology Services of Aberdeen

    Aberdeen, South Dakota, 57401

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • Saint Anthony's Hospital at Saint Anthony's Health Center

    Alton, Illinois, 62002

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • American Fork Hospital

    American Fork, Utah, 84003

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Alaska Regional Hospital Cancer Center

    Anchorage, Alaska, 99508

  • AnMed Cancer Center

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • Hospital District Sixth of Harper County

    Anthony, Kansas, 67003

  • Langlade Memorial Hospital

    Antigo, Wisconsin, 54409

  • Fox Valley Hematology and Oncology - East Grant Street

    Appleton, Wisconsin, 54911-3496

  • Randolph Hospital

    Asheboro, North Carolina, 27203-5400

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • Northeast Georgia Cancer Care, LLC - Medical Oncology

    Athens, Georgia, 30607

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Northside Hospital Cancer Center

    Atlanta, Georgia, 30342-1611

  • Saint Joseph's Hospital of Atlanta

    Atlanta, Georgia, 30342-1701

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342

  • Auburn Regional Center for Cancer Care

    Auburn, Washington, 98002

  • MBCCOP - Medical College of Georgia Cancer Center

    Augusta, Georgia, 30912

  • Aurora Presbyterian Hospital

    Aurora, Colorado, 80012

  • University of Colorado Cancer Center at UC Health Sciences Center

    Aurora, Colorado, 80045

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60504

  • WellStar Cobb Hospital

    Austell, Georgia, 30106

  • Greater Baltimore Medical Center Cancer Center

    Baltimore, Maryland, 21204

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • Pennington Cancer Center at Baton Rouge General

    Baton Rouge, Louisiana, 70806

  • Mary Bird Perkins Cancer Center - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • MeritCare Bemidji

    Bemidji, Minnesota, 56601

  • Green Mountain Oncology Group

    Bennington, Vermont, 05201

  • Hematology Oncology Associates of the Quad Cities

    Bettendorf, Iowa, 52722

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Bismarck Cancer Center

    Bismarck, North Dakota, 58501

  • Medcenter One Hospital Cancer Care Center

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, PC

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center Cancer Center

    Bismarck, North Dakota, 58502

  • Bloomington Hospital Regional Cancer Institute

    Bloomington, Indiana, 47403

  • Mountain States Tumor Institute at St. Luke's Regional Medical Center

    Boise, Idaho, 83712

  • Boston University Cancer Research Center

    Boston, Massachusetts, 02118

  • Boulder Community Hospital

    Boulder, Colorado, 80301-9019

  • Wood County Oncology Center

    Bowling Green, Ohio, 43402

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • Veterans Affairs Medical Center - Brooklyn

    Brooklyn, New York, 11209

  • St. Joseph Regional Cancer Center

    Bryan, Texas, 77802

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Veterans Affairs Medical Center - Buffalo

    Buffalo, New York, 14215

  • Lahey Clinic Medical Center - Burlington

    Burlington, Massachusetts, 01805

  • Alamance Cancer Center at Alamance Regional Medical Center

    Burlington, North Carolina, 27216

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Eden Medical Center

    Castro Valley, California, 94546

  • Valley Medical Oncology Consultants - Castro Valley

    Castro Valley, California, 94546

  • Sandra L. Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Iowa Blood and Cancer Care

    Cedar Rapids, Iowa, 52402

  • St. Luke's Hospital

    Cedar Rapids, Iowa, 52402

  • Mercy Regional Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Providence Centralia Hospital

    Centralia, Washington, 98531-9027

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • West Virginia University Health Sciences Center - Charleston

    Charleston, West Virginia, 25304

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • Saint Luke's Hospital

    Chesterfield, Missouri, 63017

  • Mount Sinai Hospital Medical Center

    Chicago, Illinois, 60608

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612-7243

  • Resurrection Medical Center

    Chicago, Illinois, 60631

  • Creticos Cancer Center at Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Marshfield Clinic - Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • Veterans Affairs Medical Center - Cincinnati

    Cincinnati, Ohio, 45220

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • MetroHealth Cancer Care Center at MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Medical Oncology and Hematology Associates - West Des Moines

    Clive, Iowa, 50325

  • North Coast Cancer Care - Clyde

    Clyde, Ohio, 43410

  • Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, 80933

  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210-1240

  • New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care

    Concord, New Hampshire, 03301

  • Cookeville Regional Medical Center

    Cookeville, Tennessee, 38501

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

  • Heartland Oncology and Hematology

    Council Bluffs, Iowa, 51503

  • Veterans Affairs Medical Center - Dallas

    Dallas, Texas, 75216

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Praxair Cancer Center at Danbury Hospital

    Danbury, Connecticut, 06810

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania, 17822-0001

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Genesis Regional Cancer Center at Genesis Medical Center

    Davenport, Iowa, 52803

  • Genesis Medical Center - West Campus

    Davenport, Iowa, 52804

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • CCOP - Dayton

    Dayton, Ohio, 45420

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Charles B. Eberhart Cancer Center at DeKalb Medical Center

    Decatur, Georgia, 30033

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Denver Health Medical Center

    Denver, Colorado, 80204

  • St. Anthony Central Hospital

    Denver, Colorado, 80204

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Presbyterian - St. Luke's Medical Center

    Denver, Colorado, 80218

  • St. Joseph Hospital

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado, 80220

  • CCOP - Colorado Cancer Research Program

    Denver, Colorado, 80224-2522

  • Mercy Capitol Hospital

    Des Moines, Iowa, 50307

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at Mercy Cancer Center

    Des Moines, Iowa, 50314

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Duluth Clinic Cancer Center - Duluth

    Duluth, Minnesota, 55805-1983

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Miller - Dwan Medical Center

    Duluth, Minnesota, 55805

  • Veterans Affairs Medical Center - Durham

    Durham, North Carolina, 27705

  • Veterans Affairs Medical Center - East Orange

    East Orange, New Jersey, 07018-1095

  • CCOP - Hematology-Oncology Associates of Central New York

    East Syracuse, New York, 13057

  • Shore Regional Cancer Center at Memorial Hospital - Easton

    Easton, Maryland, 21601

  • Easton Regional Cancer Center at Easton Hospital

    Easton, Pennsylvania, 18042

  • Marshfield Clinic Cancer Care at Regional Cancer Center

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Shaw Regional Cancer Center

    Edwards, Colorado, 81632

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Sherman Hospital

    Elgin, Illinois, 60123

  • Alexian Brothers Radiation Oncology

    Elk Grove Village, Illinois, 60007

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn

    Elkhorn, Wisconsin, 53121

  • Union Hospital Cancer Program at Union Hospital

    Elkton, Maryland, 21921

  • Elmhurst Memorial Hospital

    Elmhurst, Illinois, 60126

  • Falck Cancer Center at Arnot Ogden Medical Center

    Elmira, New York, 14905

  • Hematology Oncology Center

    Elyria, Ohio, 44035

  • Swedish Medical Center

    Englewood, Colorado, 80110

  • Green Bay Oncology, Limited - Escanaba

    Escanaba, Michigan, 49431

  • Evanston Hospital

    Evanston, Illinois, 60201-1781

  • Center for Cancer Care at Exeter Hospital

    Exeter, New Hampshire, 03833

  • Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • Dakota Cancer Institute at Dakota Clinic - South University

    Fargo, North Dakota, 58103

  • CCOP - MeritCare Hospital

    Fargo, North Dakota, 58122

  • MeritCare Broadway

    Fargo, North Dakota, 58122

  • St. Francis Hospital

    Federal Way, Washington, 98003

  • Fergus Falls Medical Group, PA

    Fergus Falls, Minnesota, 56537

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Hunterdon Regional Cancer Center at Hunterdon Medical Center

    Flemington, New Jersey, 08822

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • McLeod Regional Medical Center

    Florence, South Carolina, 29501

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80528

  • Broward General Medical Center Cancer Center

    Fort Lauderdale, Florida, 33316

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234-6200

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

    Fort Smith, Arkansas, 72903

  • MetroWest Medical Center - Framingham Union Hospital

    Framingham, Massachusetts, 01702

  • Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Oncology Alliance - Franklin

    Franklin, Wisconsin, 53132

  • Fredericksburg Oncology, Incorporated

    Fredericksburg, Virginia, 22401

  • Leonard C. Ferguson Cancer Center

    Freeport, Illinois, 61032

  • Valley Medical Oncology

    Fremont, California, 94538

  • Cancer Care Associates

    Fresno, California, 93720

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Glendale Memorial Hospital Comprehensive Cancer Center

    Glendale, California, 91204

  • Oncology Alliance, SC - Milwaukee - East

    Glendale, Wisconsin, 53212-1038

  • Valley View Hospital Cancer Center

    Glenwood Springs, Colorado, 81601

  • Riverside Middle Peninsula Cancer Center

    Gloucester, Virginia, 23061

  • Southeastern Medical Oncology Center - Goldsboro

    Goldsboro, North Carolina, 27534

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Center for Cancer Care at Goshen General Hospital

    Goshen, Indiana, 46526

  • Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center

    Grand Island, Nebraska, 68803

  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

    Grand Junction, Colorado, 81502

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Big Sky Oncology

    Great Falls, Montana, 59405-5309

  • Frontier Cancer Center

    Great Falls, Montana, 59405

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54301-3526

  • Green Bay Oncology, Limited at St. Mary's Hospital

    Green Bay, Wisconsin, 54303

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    Greensboro, North Carolina, 27403-1198

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Ingalls Cancer Care Center at Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Northern Montana Hospital

    Havre, Montana, 59501

  • Geisinger Hazleton Cancer Center

    Hazleton, Pennsylvania, 18201

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Veterans Affairs Medical Center - Hines

    Hines, Illinois, 60141

  • Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • OnCare Hawaii, Incorporated - Lusitana

    Honolulu, Hawaii, 96813

  • Queen's Cancer Institute at Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital, Incorporated

    Honolulu, Hawaii, 96813

  • Hawaii Medical Center - East

    Honolulu, Hawaii, 96817

  • OnCare Hawaii, Incorporated - Kuakini

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859

  • New Hampshire Oncology - Hematology, PA - Hooksett

    Hooksett, New Hampshire, 03106

  • Baylor University Medical Center - Houston

    Houston, Texas, 77030

  • Ben Taub General Hospital

    Houston, Texas, 77030

  • Methodist Hospital

    Houston, Texas, 77030

  • St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital

    Houston, Texas, 77030

  • Veterans Affairs Medical Center - Houston

    Houston, Texas, 77030

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Independence Regional Health Center

    Independence, Missouri, 64050

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Veterans Affairs Medical Center - Indianapolis

    Indianapolis, Indiana, 46202

  • William N. Wishard Memorial Hospital

    Indianapolis, Indiana, 46202

  • Dickinson County Healthcare System

    Iron Mountain, Michigan, 49801

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • University of Mississippi Cancer Clinic

    Jackson, Mississippi, 39216

  • Veterans Affairs Medical Center - Jackson

    Jackson, Mississippi, 39216

  • UW Cancer Center Johnson Creek

    Johnson Creek, Wisconsin, 53038

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Freeman Cancer Institute at Freeman Health System

    Joplin, Missouri, 64804

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Provena St. Mary's Regional Cancer Center - Kankakee

    Kankakee, Illinois, 60901

  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Truman Medical Center - Hospital Hill

    Kansas City, Missouri, 64108

  • Saint Luke's Cancer Institute at Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • St. Joseph Medical Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Parvin Radiation Oncology

    Kansas City, Missouri, 64116

  • Heartland Hematology Oncology Associates, Incorporated

    Kansas City, Missouri, 64118

  • Veterans Affairs Medical Center - Kansas City

    Kansas City, Missouri, 64128

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Good Samaritan Cancer Center at Good Samaritan Hospital

    Kearney, Nebraska, 68848-1990

  • Columbia Basin Hematology

    Kennewick, Washington, 99336

  • Oncology Alliance - Kenosha South

    Kenosha, Wisconsin, 53143

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37662

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • Cascade Cancer Center at Evergreen Hospital Medical Center

    Kirkland, Washington, 98033

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • Howard Community Hospital

    Kokomo, Indiana, 46904

  • Gundersen Lutheran Center for Cancer and Blood

    La Crosse, Wisconsin, 54601

  • La Grange Memorial Hospital

    La Grange, Illinois, 60525

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236

  • Lakes Region General Hospital

    Laconia, New Hampshire, 03246

  • Clarian Arnett Cancer Care

    Lafayette, Indiana, 47904

  • Haematology-Oncology Associates of Ohio and Michigan, PC

    Lambertville, Michigan, 48144

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Nevada Cancer Institute

    Las Vegas, Nevada, 89135

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Gwinnett Medical Center

    Lawrenceville, Georgia, 30045

  • Cleo Craig Cancer Research Clinic

    Lawton, Oklahoma, 73505

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Cancer Centers of Central Florida, PA

    Leesburg, Florida, 34788

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Liberty Hospital

    Liberty, Missouri, 64068

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Logan Regional Hospital

    Logan, Utah, 84321

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Hope Cancer Care Center at Longmont United Hospital

    Longmont, Colorado, 80501

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40292

  • McKee Medical Center

    Loveland, Colorado, 80539

  • UMC Southwest Cancer and Research Center

    Lubbock, Texas, 79415-3364

  • Lynchburg Hematology-Oncology Clinic

    Lynchburg, Virginia, 24501

  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Manchester Memorial Hospital

    Manchester, Connecticut, 06040

  • Holy Family Memorial Medical Center Cancer Care Center

    Manitowoc, Wisconsin, 54221-1450

  • Minnesota Oncology Hematology, PA - Maplewood

    Maplewood, Minnesota, 55109

  • Kennestone Cancer Center at Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

    Marlton, New Jersey, 08053

Other trials in United States

About this study

Official title: Phase III Study of Docetaxel and Atrasentan Versus Docetaxel and Placebo for Patients With Advanced Hormone Refractory Prostate Cancer

RATIONALE: Drugs used in chemotherapy, such as docetaxel, prednisone, and atrasentan work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether docetaxel, prednisone, and atrasentan are more effective than docetaxel and prednisone in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying docetaxel, prednisone, and atrasentan to see how well they work compared to docetaxel and prednisone in treating patients with stage IV prostate cancer and bone metastases that did not respond to previous hormone therapy.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the survival and progression-free survival of patients with hormone-refractory stage IV prostate cancer and bone metastases treated with docetaxel and prednisone combined with either atrasentan vs placebo.

Secondary

  • Compare pain progression of patients treated with these regimens.
  • Compare the qualitative and quantitative toxicity of these regimens in these patients.
  • Compare the quality of life, in terms of palliation of metastatic bone pain and improvement in functional status, of patients treated with these regimens.
  • Compare prostate-specific antigen (PSA) response rates in patients treated with these regimens.
  • Compare objective response in patients with measurable disease treated with these regimens.
  • Determine whether a 30% reduction in PSA and the slope of PSA from baseline to 3 months is a surrogate marker for survival in patients treated with these regimens.
  • Correlate PSA progression with clinical progression and death in patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease progression (measurable or non-measurable disease progression vs prostate-specific antigen progression only), use of bisphosphonates at study entry (yes vs no), worst pain, measured by the Brief Pain Inventory "pain" scale (< grade 4 vs ≥ grade 4), and extraskeletal metastases (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks in the absence of disease progression* or unacceptable toxicity.
  • Arm II: Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks in the absence of disease progression* or unacceptable toxicity.

NOTE: *Patients with PSA progression alone will be allowed to continue treatment

Quality of life is assessed at baseline, before courses 4, 7, and 10, and then after completion of study treatment.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 3 years from study entry.

PROJECTED ACCRUAL: A total of 930 patients will be accrued for this study within 4 years.

Being tested
atrasentan hydrochloride, docetaxel, prednisone, placebo
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer, bone metastases
Medical subject headings
Neoplasm Metastasis, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • atrasentan hydrochlorideDrug

    Also called atrasentan

    Given orally

  • docetaxelDrug

    Also called taxotere

    Docetaxel given IV and prednisone given orally

  • prednisoneDrug

    Also called steroid

    Docetaxel given IV and prednisone given orally

  • placeboOther

    Given orally

Study groups in NCT00134056
Study groupRoleWhat they receive
Arm I: placeboActive comparatorPatients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.
Receives: Drug: docetaxel; Drug: prednisone; Other: placebo
Arm II: atrasentan hydrochlorideExperimentalPatients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.
Receives: Drug: atrasentan hydrochloride; Drug: docetaxel; Drug: prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer.

    Measured from date of registration to date of death due to any cause. Patient last known to be alive are censored at date of last contact.

    Measured: Up to 7 years after study opens

  2. Compare Progression-free Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer.

    Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients without progression are censored at date of last contact. Disease progression is defined by confirmed bone disease progression, soft tissue or pain progression.

    Measured: Up to 7 years after study opens

Secondary outcomes (4)

  1. Compare Pain Progression Between the Two Study Arms.

    Pain progression is defined as patients reporting an increase of at least two Worst Pain points, maintained for at least two consecutive assessments, increase to Level 3 (strong opioid) on the Pain Medication Log Analgesic Code for patients receiving Level 2 (weak opioid) analgesics at randomization, or an increase to Level 2 or 3 analgesics for patients receiving Level 0 or 1 analgesics at randomization.

    Measured: Up to 52 weeks

  2. Compare Qualitative and Quantitative Toxicity Between the Two Study Arms

    Only adverse events that are possibly, probably or definitely related to study drug are reported.

    Measured: Assessed every 3 weeks up to 52 weeks

  3. Compare Prostate Specific Antigen (PSA) Response Rates Between the Experimental Arm and the Standard Arm.

    PSA Partial Response: Greater than or equal to 50% reduction in baseline PSA. There must be no evidence of soft tissue progression, or confirmed none disease progression, or pain progression.

    Measured: Up to 7 years after study opens

  4. Compare Objective Responses Between the Two Treatment Groups in Patients With Measurable Disease as Defined by RECIST Criteria.

    Complete Response (CR): Complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. PSA ≤ .2 ng/ml. Partial Response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions.

    Measured: Up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2005 (estimated)
  2. Study startAug 2006
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,038 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00134056
Sponsor's protocol ID
CDR0000439434
Other IDs
S0421, U10CA032102
Status last verified
Oct 2021
First submitted
22 Aug 2005
Last updated
27 Oct 2021
Data monitoring committee
Yes
Individual data sharing
Yes: http://swog.org/Visitors/Download/Policies/Policy43.pdf

Publications

  • Goldkorn A, Ely B, Quinn DI, et al.: Results of telomerase activity measurements from live circulating tumor cells captured on a slot microfilter in a phase III SWOG-coordinated prostate cancer trial (S0421). [Abstract] J Clin Oncol 30 (Suppl 15): A-4663, 2012.

  • Lara P, Ely B, Quinn DI, et al.: SWOG 0421: prognostic and predictive value of bone metabolism biomarkers (BMB) in castration resistant prostate cancer (CRPC) patients (pts) with skeletal metastases treated with docetaxel (DOC) with or without atrasentan (ATR). [Abstract] J Clin Oncol 30 (Suppl 15): A-4547, 2012.

  • Quinn DI, Tangen CM, Hussain M, et al.: SWOG S0421: phase III study of docetaxel (D) and atrasentan (A) versus docetaxel and placebo (P) for men with advanced castrate resistant prostate cancer (CRPC). [Abstract] J Clin Oncol 30 (Suppl 15): A-4511, 2012.

  • Goldkorn A, Ely B, Quinn DI, Tangen CM, Fink LM, Xu T, Twardowski P, Van Veldhuizen PJ, Agarwal N, Carducci MA, Monk JP 3rd, Datar RH, Garzotto M, Mack PC, Lara P Jr, Higano CS, Hussain M, Thompson IM Jr, Cote RJ, Vogelzang NJ. Circulating tumor cell counts are prognostic of overall survival in SWOG S0421: a phase III trial of docetaxel with or without atrasentan for metastatic castration-resistant prostate cancer. J Clin Oncol. 2014 Apr 10;32(11):1136-42. doi: 10.1200/JCO.2013.51.7417. Epub 2014 Mar 10.

    PubMed 24616308

  • Goldkorn A, Xu T, Lu B, et al.: Circulating tumor cell capture and analysis in a multicenter SWOG-coordinated prostate cancer trial. [Abstract] J Clin Oncol 28 (Suppl 15): A-TPS342, 2010.

  • Lara PN Jr, Ely B, Quinn DI, Mack PC, Tangen C, Gertz E, Twardowski PW, Goldkorn A, Hussain M, Vogelzang NJ, Thompson IM, Van Loan MD. Serum biomarkers of bone metabolism in castration-resistant prostate cancer patients with skeletal metastases: results from SWOG 0421. J Natl Cancer Inst. 2014 Apr;106(4):dju013. doi: 10.1093/jnci/dju013. Epub 2014 Feb 24.

    PubMed 24565955

  • Quinn DI, Tangen CM, Hussain M, Lara PN Jr, Goldkorn A, Moinpour CM, Garzotto MG, Mack PC, Carducci MA, Monk JP, Twardowski PW, Van Veldhuizen PJ, Agarwal N, Higano CS, Vogelzang NJ, Thompson IM Jr. Docetaxel and atrasentan versus docetaxel and placebo for men with advanced castration-resistant prostate cancer (SWOG S0421): a randomised phase 3 trial. Lancet Oncol. 2013 Aug;14(9):893-900. doi: 10.1016/S1470-2045(13)70294-8. Epub 2013 Jul 17.

    PubMed 23871417

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing atrasentan hydrochloride, docetaxel and prednisone in people with Metastatic Cancer and Prostate Cancer, run by SWOG Cancer Research Network at 554 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 554 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer. (time frame: Up to 7 years after study opens). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00134056, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.

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