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
Metastatic Cancer, Prostate Cancer

About this trial
This is an interventional treatment trial for Metastatic Cancer focused on measuring adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer, bone metastases
Eligibility Criteria
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)
Sites / Locations
- Providence Cancer Center at Providence Hospital
- Alaska Regional Hospital Cancer Center
- Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
- Mayo Clinic Scottsdale
- Arizona Cancer Center at University of Arizona Health Sciences Center
- Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
- East Bay Radiation Oncology Center
- Eden Medical Center
- Valley Medical Oncology Consultants - Castro Valley
- Valley Medical Oncology
- Cancer Care Associates
- Glendale Memorial Hospital Comprehensive Cancer Center
- Rebecca and John Moores UCSD Cancer Center
- USC/Norris Comprehensive Cancer Center and Hospital
- Contra Costa Regional Medical Center
- Tibotec Therapeutics - Division of Ortho Biotech Products, LP
- Community Hospital of the Monterey Peninsula Comprehensive Cancer Center
- Camino Medical Group - Treatment Center
- El Camino Hospital Cancer Center
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Breast Surgeons, Incorporated
- CCOP - Bay Area Tumor Institute
- Larry G Strieff MD Medical Corporation
- Tom K Lee, Incorporated
- Desert Regional Medical Center Comprehensive Cancer Center
- Palo Alto Medical Foundation
- PCR Oncology
- Valley Care Medical Center
- Valley Medical Oncology Consultants - Pleasanton
- Lucy Curci Cancer Center at Eisenhower Memorial Hospital and Medical Center
- University of California Davis Cancer Center
- Mercy General Hospital
- Salinas Valley Memorial Hospital
- Doctors Medical Center - San Pablo Campus
- Tahoe Forest Cancer Center
- Aurora Presbyterian Hospital
- University of Colorado Cancer Center at UC Health Sciences Center
- Boulder Community Hospital
- Penrose Cancer Center at Penrose Hospital
- Denver Health Medical Center
- St. Anthony Central Hospital
- Porter Adventist Hospital
- Presbyterian - St. Luke's Medical Center
- St. Joseph Hospital
- Rose Medical Center
- Veterans Affairs Medical Center - Denver
- CCOP - Colorado Cancer Research Program
- Shaw Regional Cancer Center
- Swedish Medical Center
- Poudre Valley Hospital
- Front Range Cancer Specialists
- Valley View Hospital Cancer Center
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
- North Colorado Medical Center
- Sky Ridge Medical Center
- Hope Cancer Care Center at Longmont United Hospital
- McKee Medical Center
- Montrose Memorial Hospital Cancer Center
- St. Mary - Corwin Regional Medical Center
- North Suburban Medical Center
- Exempla Lutheran Medical Center
- Praxair Cancer Center at Danbury Hospital
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Manchester Memorial Hospital
- Middlesex Hospital Cancer Center
- Connecticut Oncology & Hematology - Torrington
- CCOP - Christiana Care Health Services
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
- Sibley Memorial Hospital
- Veterans Affairs Medical Center - Washington, DC
- Broward General Medical Center Cancer Center
- Memorial Cancer Institute at Memorial Regional Hospital
- Cancer Centers of Central Florida, PA
- University of Miami Sylvester Comprehensive Cancer Center - Miami
- Integrated Community Oncology Network - Orange Park
- Florida Hospital Cancer Institute at Florida Hospital Orlando
- Sacred Heart Cancer Center at Sacred Heart Hospital
- West Florida Cancer Institute at West Florida Hospital - Pensacola
- Space Coast Medical Associates
- Northeast Georgia Cancer Care, LLC - Medical Oncology
- Piedmont Hospital
- Northside Hospital Cancer Center
- Saint Joseph's Hospital of Atlanta
- CCOP - Atlanta Regional
- MBCCOP - Medical College of Georgia Cancer Center
- WellStar Cobb Hospital
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
- Gwinnett Medical Center
- Kennestone Cancer Center at Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Harbin Clinic Cancer Center - Medical Oncology
- Kapiolani Medical Center at Pali Momi
- Cancer Research Center of Hawaii
- OnCare Hawaii, Incorporated - Lusitana
- Queen's Cancer Institute at Queen's Medical Center
- Straub Clinic and Hospital, Incorporated
- Hawaii Medical Center - East
- OnCare Hawaii, Incorporated - Kuakini
- Kapiolani Medical Center for Women and Children
- Tripler Army Medical Center
- Maui Memorial Medical Center
- Pacific Cancer Institute - Maui
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
- Saint Anthony's Hospital at Saint Anthony's Health Center
- Rush-Copley Cancer Care Center
- Mount Sinai Hospital Medical Center
- University of Illinois Cancer Center
- Resurrection Medical Center
- Creticos Cancer Center at Advocate Illinois Masonic Medical Center
- Decatur Memorial Hospital Cancer Care Institute
- Sherman Hospital
- Alexian Brothers Radiation Oncology
- Elmhurst Memorial Hospital
- Evanston Hospital
- Leonard C. Ferguson Cancer Center
- Ingalls Cancer Care Center at Ingalls Memorial Hospital
- Veterans Affairs Medical Center - Hines
- Joliet Oncology-Hematology Associates, Limited - West
- Provena St. Mary's Regional Cancer Center - Kankakee
- La Grange Memorial Hospital
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Good Samaritan Regional Health Center
- Edward Hospital Cancer Center
- Hematology Oncology Consultants - Naperville
- Swedish-American Regional Cancer Center
- Regional Cancer Center at Memorial Medical Center
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- Central Dupage Cancer Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Bloomington Hospital Regional Cancer Institute
- Elkhart General Hospital
- Center for Cancer Care at Goshen General Hospital
- Indiana University Melvin and Bren Simon Cancer Center
- Veterans Affairs Medical Center - Indianapolis
- William N. Wishard Memorial Hospital
- Howard Community Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Clarian Arnett Cancer Care
- Saint Anthony Memorial Health Centers
- Medical Consultants, PC at Ball Memorial Cancer Center
- Community Hospital
- Reid Hospital & Health Care Services
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- Saint Joseph Regional Medical Center
- South Bend Clinic
- McFarland Clinic, PC
- Hematology Oncology Associates of the Quad Cities
- Iowa Blood and Cancer Care
- St. Luke's Hospital
- Mercy Regional Cancer Center at Mercy Medical Center
- Medical Oncology and Hematology Associates - West Des Moines
- Heartland Oncology and Hematology
- Genesis Regional Cancer Center at Genesis Medical Center
- Genesis Medical Center - West Campus
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- McCreery Cancer Center at Ottumwa Regional
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Cedar Valley Medical Specialists, PC - West Ridgeway Avenue
- Covenant Cancer Treatment Center
- Hospital District Sixth of Harper County
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Cancer Center of Kansas, PA - Kingman
- Lawrence Memorial Hospital
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Menorah Medical Center
- Saint Luke's Hospital - South
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Tammy Walker Cancer Center at Salina Regional Health Center
- Shawnee Mission Medical Center
- Cotton-O'Neil Cancer Center
- St. Francis Comprehensive Cancer Center
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- James Graham Brown Cancer Center at University of Louisville
- Pennington Cancer Center at Baton Rouge General
- Mary Bird Perkins Cancer Center - Baton Rouge
- MBCCOP - LSU Health Sciences Center
- Medical Center of Louisiana - New Orleans
- Highland Clinic
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences
- Greater Baltimore Medical Center Cancer Center
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Shore Regional Cancer Center at Memorial Hospital - Easton
- Union Hospital Cancer Program at Union Hospital
- Boston University Cancer Research Center
- Lahey Clinic Medical Center - Burlington
- MetroWest Medical Center - Framingham Union Hospital
- Baystate Regional Cancer Program at D'Amour Center for Cancer Care
- Hickman Cancer Center at Bixby Medical Center
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- University of Michigan Comprehensive Cancer Center
- Battle Creek Health System Cancer Care Center
- Mecosta County Medical Center
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Josephine Ford Cancer Center at Henry Ford Hospital
- Green Bay Oncology, Limited - Escanaba
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Butterworth Hospital at Spectrum Health
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Health Care
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Dickinson County Healthcare System
- Foote Memorial Hospital
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Haematology-Oncology Associates of Ohio and Michigan, PC
- Sparrow Regional Cancer Center
- St. Mary Mercy Hospital
- Upper Michigan Cancer Center at Marquette General Hospital
- Community Cancer Center of Monroe
- Mercy Memorial Hospital - Monroe
- Clemens Regional Medical Center
- Mercy General Health Partners
- St. Joseph Mercy Oakland
- Mercy Regional Cancer Center at Mercy Hospital
- Seton Cancer Institute at Saint Mary's - Saginaw
- Lakeland Regional Cancer Care Center - St. Joseph
- Providence Cancer Institute at Providence Hospital - Southfield Campus
- Munson Medical Center
- St. John Macomb Hospital
- Metro Health Hospital
- MeritCare Bemidji
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Duluth Clinic Cancer Center - Duluth
- CCOP - Duluth
- Miller - Dwan Medical Center
- Fairview Southdale Hospital
- Fergus Falls Medical Group, PA
- Mercy and Unity Cancer Center at Unity Hospital
- Minnesota Oncology Hematology, PA - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Veterans Affairs Medical Center - Minneapolis
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
- Mayo Clinic Cancer Center
- CentraCare Clinic - River Campus
- Coborn Cancer Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- United Hospital
- St. Francis Cancer Center at St. Francis Medical Center
- Ridgeview Medical Center
- Willmar Cancer Center at Rice Memorial Hospital
- Minnesota Oncology Hematology, PA - Woodbury
- University of Mississippi Cancer Clinic
- Veterans Affairs Medical Center - Jackson
- Regional Cancer Center at Singing River Hospital
- Saint Francis Medical Center
- Saint Luke's Hospital
- Independence Regional Health Center
- Freeman Cancer Institute at Freeman Health System
- Truman Medical Center - Hospital Hill
- Saint Luke's Cancer Institute at Saint Luke's Hospital
- St. Joseph Medical Center
- North Kansas City Hospital
- Parvin Radiation Oncology
- Heartland Hematology Oncology Associates, Incorporated
- Veterans Affairs Medical Center - Kansas City
- CCOP - Kansas City
- Research Medical Center
- Saint Luke's East - Lee's Summit
- Liberty Hospital
- Heartland Regional Medical Center
- Midwest Hematology Oncology Group, Incorporated
- Missouri Baptist Cancer Center
- Arch Medical Services, Incorporated at Center for Cancer Care and Research
- CCOP - St. Louis-Cape Girardeau
- David C. Pratt Cancer Center at St. John's Mercy
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare Cancer Care Services
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Big Sky Oncology
- Frontier Cancer Center
- Great Falls Clinic - Main Facility
- Sletten Cancer Institute at Benefis Healthcare
- Northern Montana Hospital
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology at KRMC
- Kalispell Regional Medical Center
- Community Medical Center
- Guardian Oncology and Center for Wellness
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
- Good Samaritan Cancer Center at Good Samaritan Hospital
- Callahan Cancer Center at Great Plains Regional Medical Center
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- University Medical Center of Southern Nevada
- CCOP - Nevada Cancer Research Foundation
- Nevada Cancer Institute
- Renown Institute for Cancer at Renown Regional Medical Center
- New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
- Center for Cancer Care at Exeter Hospital
- New Hampshire Oncology - Hematology, PA - Hooksett
- Lakes Region General Hospital
- Veterans Affairs Medical Center - East Orange
- Hunterdon Regional Cancer Center at Hunterdon Medical Center
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
- Jersey Shore Cancer Center at Jersey Shore University Medical Center
- Valley Hospital - Ridgewood
- Somerset Medical Center
- Frederick R. and Betty M. Smith Cancer Treatment Center
- Cancer Institute of New Jersey at Cooper - Voorhees
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
- Our Lady of Mercy Medical Center Comprehensive Cancer Center
- Veterans Affairs Medical Center - Brooklyn
- Veterans Affairs Medical Center - Buffalo
- Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
- CCOP - Hematology-Oncology Associates of Central New York
- Falck Cancer Center at Arnot Ogden Medical Center
- Northern Westchester Hospital
- New York Weill Cornell Cancer Center at Cornell University
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
- Interlakes Oncology/Hematology PC
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Nalitt Cancer Institute at Staten Island University Hospital
- Stony Brook University Cancer Center
- SUNY Upstate Medical University Hospital
- Veterans Affairs Medical Center - Syracuse
- Randolph Hospital
- Mission Hospitals - Memorial Campus
- Alamance Cancer Center at Alamance Regional Medical Center
- Presbyterian Cancer Center at Presbyterian Hospital
- Veterans Affairs Medical Center - Durham
- Southeastern Medical Oncology Center - Goldsboro
- Wayne Memorial Hospital, Incorporated
- Moses Cone Regional Cancer Center at Wesley Long Community Hospital
- Kinston Medical Specialists
- Annie Penn Cancer Center
- Rutherford Hospital
- Marion L. Shepard Cancer Center at Beaufort County Hospital
- Bismarck Cancer Center
- Medcenter One Hospital Cancer Care Center
- Mid Dakota Clinic, PC
- St. Alexius Medical Center Cancer Center
- Dakota Cancer Institute at Dakota Clinic - South University
- CCOP - MeritCare Hospital
- MeritCare Broadway
- Trinity CancerCare Center
- McDowell Cancer Center at Akron General Medical Center
- Wood County Oncology Center
- Veterans Affairs Medical Center - Cincinnati
- Charles M. Barrett Cancer Center at University Hospital
- MetroHealth Cancer Care Center at MetroHealth Medical Center
- North Coast Cancer Care - Clyde
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- CCOP - Dayton
- Veterans Affairs Medical Center - Dayton
- Hematology Oncology Center
- Blanchard Valley Medical Associates
- Middletown Regional Hospital
- Wayne Hospital
- Charles F. Kettering Memorial Hospital
- St. Rita's Medical Center
- Northwest Ohio Oncology Center
- St. Luke's Hospital
- Fisher-Titus Medical Center
- St. Charles Mercy Hospital
- Toledo Clinic - Oregon
- North Coast Cancer Care, Incorporated
- Flower Hospital Cancer Center
- Mercy Hospital of Tiffin
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical University of Ohio Cancer Center
- CCOP - Toledo Community Hospital
- St. Anne Mercy Hospital
- Toledo Clinic, Incorporated - Main Clinic
- UVMC Cancer Care Center at Upper Valley Medical Center
- Fulton County Health Center
- Clinton Memorial Hospital
- United States Air Force Medical Center - Wright-Patterson
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Cleo Craig Cancer Research Clinic
- Bay Area Hospital
- Providence Milwaukie Hospital
- Providence Cancer Center at Providence Portland Medical Center
- Adventist Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Kaiser Permanente Health Care - Portland
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
- Bryn Mawr Hospital
- Geisinger Cancer Institute at Geisinger Health
- Easton Regional Cancer Center at Easton Hospital
- Geisinger Hazleton Cancer Center
- Cancer Center of Paoli Memorial Hospital
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
- Guthrie Cancer Center at Guthrie Clinic Sayre
- Hematology and Oncology Associates of Northeastern Pennsylvania
- Geisinger Medical Group - Scenery Park
- Mount Nittany Medical Center
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- CCOP - Main Line Health
- Lankenau Cancer Center at Lankenau Hospital
- AnMed Cancer Center
- Hollings Cancer Center at Medical University of South Carolina
- McLeod Regional Medical Center
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Oncology Services of Aberdeen
- Rapid City Regional Hospital
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sanford Cancer Center at Sanford USD Medical Center
- Cookeville Regional Medical Center
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
- Thompson Cancer Survival Center
- University of Tennessee Cancer Institute - Memphis
- Veterans Affairs Medical Center - Memphis
- Harrington Cancer Center
- St. Joseph Regional Cancer Center
- Veterans Affairs Medical Center - Dallas
- Medical City Dallas Hospital
- Brooke Army Medical Center
- Baylor University Medical Center - Houston
- Ben Taub General Hospital
- Methodist Hospital
- St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
- Veterans Affairs Medical Center - Houston
- Wilford Hall Medical Center
- UMC Southwest Cancer and Research Center
- Veterans Affairs Medical Center - San Antonio (Murphy)
- University of Texas Health Science Center at San Antonio
- Cancer Therapy and Research Center
- University Hospital - San Antonio
- CCOP - Scott and White Hospital
- American Fork Hospital
- Sandra L. Maxwell Cancer Center
- Logan Regional Hospital
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center - East Campus
- LDS Hospital
- Utah Cancer Specialists at UCS Cancer Center
- Huntsman Cancer Institute at University of Utah
- Green Mountain Oncology Group
- Danville Regional Medical Center
- Fredericksburg Oncology, Incorporated
- Riverside Middle Peninsula Cancer Center
- Lynchburg Hematology-Oncology Clinic
- Peninsula Cancer Institute - Newport News Office
- Southwest Virginia Regional Cancer Center at Wellmonth Health
- Veterans Affairs Medical Center - Richmond
- Virginia Commonwealth University Massey Cancer Center
- Peninsula Cancer Institute - Williamsburg Office
- Auburn Regional Center for Cancer Care
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- Providence Centralia Hospital
- St. Francis Hospital
- Columbia Basin Hematology
- Cascade Cancer Center at Evergreen Hospital Medical Center
- Providence St. Peter Hospital Regional Cancer Center
- Harrison Poulsbo Hematology and Onocology
- Good Samaritan Cancer Center
- Valley Medical Center
- CCOP - Virginia Mason Research Center
- Harborview Medical Center
- Minor and James Medical, PLLC
- Pacific Medical Center
- Fred Hutchinson Cancer Research Center
- Group Health Central Hospital
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Polyclinic First Hill
- University Cancer Center at University of Washington Medical Center
- Cancer Care Northwest - Spokane South
- Rockwood Clinic Cancer Treatment Center
- Evergreen Hematology and Oncology, PS
- Franciscan Cancer Center at St. Joseph Medical Center
- Allenmore Hospital
- CCOP - Northwest
- MultiCare Regional Cancer Center at Tacoma General Hospital
- St. Clare Hospital
- Southwest Washington Medical Center Cancer Center
- Wenatchee Valley Medical Center
- West Virginia University Health Sciences Center - Charleston
- Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
- Schiffler Cancer Center at Wheeling Hospital
- Langlade Memorial Hospital
- Fox Valley Hematology and Oncology - East Grant Street
- Marshfield Clinic - Chippewa Center
- Marshfield Clinic Cancer Care at Regional Cancer Center
- Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn
- Oncology Alliance - Franklin
- Oncology Alliance, SC - Milwaukee - East
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- UW Cancer Center Johnson Creek
- Oncology Alliance - Kenosha South
- Gundersen Lutheran Center for Cancer and Blood
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
- Holy Family Memorial Medical Center Cancer Care Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Marshfield Clinic - Marshfield Center
- Saint Joseph's Hospital
- Medical Consultants, Limited
- Oncology Alliance, SC - Milwaukee - South
- Froedtert Hospital and Medical College of Wisconsin
- Medical College of Wisconsin Cancer Center
- Marshfield Clinic - Lakeland Center
- Green Bay Oncology, Limited - Oconto Falls
- Ministry Medical Group at Saint Mary's Hospital
- Marshfield Clinic - Indianhead Center
- Saint Michael's Hospital Cancer Center
- Green Bay Oncology, Limited - Sturgeon Bay
- Marshfield Clinic - Wausau Center
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
- Oncology Alliance, SC - Milwaukee - West
- Marshfield Clinic - Weston Center
- Marshfield Clinic - Wisconsin Rapids Center
- Riverview UW Cancer Center at Riverview Hospital
- Rocky Mountain Oncology
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I: placebo
Arm II: atrasentan hydrochloride
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.
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.