Spots Global Cancer Trial Database for DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (AIPC Study of Calcitriol Enhancing Taxotere [ASCENT-2])
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Trial Identification
Brief Title: DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (AIPC Study of Calcitriol Enhancing Taxotere [ASCENT-2])
Official Title: A Phase 3, Randomized, Open-Label Study Evaluating DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (ASCENT-2)
Study ID: NCT00273338
Conditions
Study Description
Brief Summary: The primary objective of this study is: * To evaluate the effect of DN-101 in combination with docetaxel (ASCENT regimen) on survival in metastatic androgen-independent prostate cancer The secondary objectives of this study are: * To determine the effect of the ASCENT regimen on the rate of thromboembolic events (blood clots) * To determine the effect of the ASCENT regimen on prevention of skeletal-related events (fractures) * A Separate sub-study will be conducted at selected study sites in North America to determine the population PK of DN-101.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Birmingham Hematology & Oncology Associates, LLC, Birmingham, Alabama, United States
Northwest Alabama Cancer Center, Muscle Shoals, Alabama, United States
Alaska Clinical Research Center, Anchorage, Alaska, United States
Hematology Associates - AOA, Phoenix, Arizona, United States
Premiere Oncology of Arizona, Scottsdale, Arizona, United States
Northern Arizona Hematology & Oncology Associates, AOA, Sedona, Arizona, United States
Southern Arizona VA Healthcare System, Tucson, Arizona, United States
U of Arizona / Arizona Cancer Center, Tucson, Arizona, United States
Genesis Cancer Center, Hot Springs, Arkansas, United States
Tower Cancer Research Foundation, Beverly Hills, California, United States
Pacific Shores Medical Group, Long Beach, California, United States
The Angeles Clinic and Research Institute, Inc., Los Angeles, California, United States
UCLA department of Urology, Los Angeles, California, United States
Veterans Affairs Northern California Health Care System, Martinez, California, United States
Sutter Gould Medical Foundation, Modesto, California, United States
Monterey Bay Oncology, Monterey, California, United States
Comprehensive Cancer Center at, Palm Springs, California, United States
Sutter Cancer Center, Sacramento, California, United States
UCD Cancer Center-Clinical Trials, Sacramento, California, United States
Sharp Memorial Hospital, San Diego, California, United States
California Pacific Medical Center, San Francisco, California, United States
Stanford University, Stanford, California, United States
Rocky Mountain Cancer Centers, Colorado Springs, Colorado, United States
Georgetown University Lombardi Cancer Center, Washington, District of Columbia, United States
Pasco Hernando Oncology Associates, P.A., 14529 Cortez Blvd., Florida, United States
North Broward Medical Center, Deerfield Beach, Florida, United States
Florida Cancer Specialists, Fort Myers, Florida, United States
Broward Oncology Associates, Ft. Lauderdale, Florida, United States
Michael and Dianne Bienes Comprehensive Cancer Center, Ft. Lauderdale, Florida, United States
Gainesville Hematology Oncology Associates, Gainesville, Florida, United States
University of Florida Shands Cancer Center, Gainesville, Florida, United States
Integrated Community Oncology Network, Jacksonville, Florida, United States
Sylvester Comprehensive Cancer Center, U of Miami, Miami, Florida, United States
Innovative Medical Research of South Florida Inc., N. Miami Beach, Florida, United States
Pasco Hernando Oncology Associates P.A., New Port Richey, Florida, United States
Florida Cancer Institute, New Port Richey, Florida, United States
Ocala Oncology Center, Ocala, Florida, United States
Cancer Centers of Florida, P.A., Ocoee, Florida, United States
AYS Urology, Trinity, Florida, United States
Phoebe Cancer Center, Albany, Georgia, United States
Northeast Georgia Cancer Care, LLC, Athens, Georgia, United States
Peachtree Hematology-Oncology Consultants, PC, Atlanta, Georgia, United States
Atlanta Cancer Care, Atlanta, Georgia, United States
Northeast GA Medical Center, Gainesville, Georgia, United States
Georgia Cancer Specialist, Tucker, Georgia, United States
South Georgia Medical Center, Valdosta, Georgia, United States
Hematology Oncology Associates of Illinois, Chicago, Illinois, United States
Midwest Prostate & Urology Health Center, Chicago, Illinois, United States
Cancer Care & Hematology Specialists of Chicagoland, Niles, Illinois, United States
Oncology Specialists, Park Ridge, Illinois, United States
Swedish American Regional Cancer Center, Rockford, Illinois, United States
Hematology Oncology Associates of Illinois, L.L.C, Skokie, Illinois, United States
Central Indiana Cancer Centers, Indianapolis, Indiana, United States
Medical Consultants, PC c/o Ball Cancer Center, Muncie, Indiana, United States
Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States
Hope Center, Terre Haute, Indiana, United States
Medical Center of Vincennes, Vincennes, Indiana, United States
Iowa Cancer Care, Cedar Rapids, Iowa, United States
Mercy Medical Center, North Iowa, Mason City, Iowa, United States
Siouxland Hematology-Oncology Associates, Sioux City, Iowa, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
Hematology Oncology Life Center, Alexandria, Louisiana, United States
Maine Center for Cancer Medicine & Blood Disorders, Scarborough, Maine, United States
St. Agnes Health System, Baltimore, Maryland, United States
Maryland Oncology Hematology, P.A., Columbia, Maryland, United States
Frederick Memorial Hospital, Frederick, Maryland, United States
Henry Ford Health System, Detroit, Michigan, United States
Minnesota Oncology Hematology, P.A., Minneapolis, Minnesota, United States
MN Cooperative Group Outreach Prg., Minneapolis, Minnesota, United States
Park Nicollet Institute, Saint Louis Park, Minnesota, United States
Park Nicollet Institute, St. Louis Park, Minnesota, United States
Missouri Cancer Associates, Columbia, Missouri, United States
University of Missouri, Ellis Fischel Cancer Center, Columbia, Missouri, United States
St. Joseph Oncology, Inc., St. Joseph, Missouri, United States
Nebraska Hematology-Oncology, PC, Lincoln, Nebraska, United States
Nebraska Methodist Hospital - Oncology Research Dept, Omaha, Nebraska, United States
Horizon's West Medical Group, Scottsbluff, Nebraska, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Nevada Cancer Institute, Las Vegas, Nevada, United States
UMDNJ-Newark, Newark, New Jersey, United States
The Valley Hospital, Paramus, New Jersey, United States
Overlook Oncology Center, Summit, New Jersey, United States
New Mexico Cancer Care Associates, Sante Fe, New Mexico, United States
SUNY Downstate Medical Center, Brooklyn, New York, United States
Hematology Oncology Associates of, New City, New York, United States
Memorial Sloan-Kett, New York, New York, United States
Interlakes Foundation Inc., Rochester, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Staten Island Urological Research, PC, Staten Island, New York, United States
Raleigh Hematology Oncology Associates, Cary, North Carolina, United States
Carolina Cancer Management, Inc., Fayetteville, North Carolina, United States
Piedmont Hematology Oncology Associates, PLLC, Winston-Salem, North Carolina, United States
Dakota Cancer Institute, Fargo, North Dakota, United States
Aultman Hospital, Canton, Ohio, United States
Gabrail Cancer Center, Canton, Ohio, United States
Oncology Hematology Care, Inc., Cincinnati, Ohio, United States
The Cleveland Clinic Foundation, Cleveland, Ohio, United States
Mid Ohio Oncology/Hematology, Inc., Columbus, Ohio, United States
Dayton Oncology & Hematology, P.A., Kettering, Ohio, United States
University of Oklahoma, Oklahoma City, Oklahoma, United States
Cancer Care Associates, Oklahoma City, Oklahoma, United States
Cancer Care Associates, Tulsa, Oklahoma, United States
Willamette Valley Cancer Center, Eugene, Oregon, United States
Consultants in Medical Oncology & Hematology, Drexel Hill, Pennsylvania, United States
Hematology & Oncology Associates of Northeastern PA, Dunmore, Pennsylvania, United States
Medical Oncology Associates of Wyoming Valley, PC, Kingston, Pennsylvania, United States
St. Mary Medical Center, Langhorne, Pennsylvania, United States
Greater Philadelphia Cancer, Philadelphia, Pennsylvania, United States
Univeristy of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Pottsville Cancer Care, Pottsville, Pennsylvania, United States
Guthrie Clinic, Sayre, Pennsylvania, United States
Charleston Hematology Oncology PA, Charleston, South Carolina, United States
Charleston Cancer Center, Charleston, South Carolina, United States
Medical University Of South Carolina, Charleston, South Carolina, United States
Cancer Centers of the Carolina, Greenville, South Carolina, United States
South Carolina Cancer Specialists, Hilton Head Island, South Carolina, United States
Chattanooga Oncology & Hematology Assoc., Chattanooga, Tennessee, United States
The Jones Clinic, Germantown, Tennessee, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Texas Cancer Center-Abilene, Abilene, Texas, United States
Texas Oncology, PA, Amarillo, Texas, United States
Texas Cancer Center, Arlington, Texas, United States
Urology Associates of North Texas (UANT), Arlington, Texas, United States
Texas Oncology Cancer Center, Austin, Texas, United States
MamieMcFaddin Ward Cancer Center, Beaumont, Texas, United States
Texas Cancer Center ar Medical City, Dallas, Texas, United States
Center for Oncology Research and Treatment, PA, Dallas, Texas, United States
Texas Oncology, P.A., Dallas, Texas, United States
The Texas Cancer Center, Dallas, Texas, United States
El Paso Cancer Treatment Center-East, El Paso, Texas, United States
Texas Oncology, P.A., Fort Worth, Texas, United States
The Center for Cancer & Blood Disorders, Fort Worth, Texas, United States
Texas Oncology, P.A., Garland, Texas, United States
Texas Oncology, P.A., Houston, Texas, United States
Lake Vista Cancer Center, Lewisville, Texas, United States
Texas Oncology, P.A., Longview, Texas, United States
Southwest Cancer Treatment and Research Center, Lubbock, Texas, United States
South Texas Cancer Center - McAllen, McAllen, Texas, United States
Texas Cancer Center of Mesquite, Mesquite, Texas, United States
Allison Cancer Center, Midland, Texas, United States
Cancer Care Network of South Texas, HOAST, New Braunfels, Texas, United States
West Texas Cancer Center, Odessa, Texas, United States
Paris Regional Cancer Center, Paris, Texas, United States
South Texas Oncology and Hematology, PA, San Antonio, Texas, United States
InVisions Consultants LLC, San Antonio, Texas, United States
Texas Cancer Center- Sherman, Sherman, Texas, United States
Texas Oncology Cancer Center-Sugar Land, Sugar Land, Texas, United States
Texas Oncology, Waco, Texas, United States
Texas Oncology Cancer Care and Research Center, Waco, Texas, United States
Fairfax Northern Virginia Hematology OnCology, PC, Fairfax, Virginia, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., Salem, Virginia, United States
Highline Medical Oncology, Burien, Washington, United States
Puget Sound Cancer Centers, Edmonds, Washington, United States
University of Washington, Seattle, Washington, United States
Puget Sound Cancer Centers, Seattle, Washington, United States
Northwest Cancer Specialists, P.C., Vancouver, Washington, United States
Wenatchee Valley Medical Center, Wenatchee, Washington, United States
Yakima Valley Memorial Hospital/North Star Lodge, Yakima, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Tom Baker Cancer Center-Medical Oncology, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
BCCA-Centre for the Southern Interior, Kelowna, British Columbia, Canada
BCCA-Vancouver, Vancouver, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Island Centre, Victoria, British Columbia, Canada
Cancer Care Manitoba, Winnipeg, Manitoba, Canada
The Moncton Hospital (SERHA), Moncton, New Brunswick, Canada
Dr. Leon Richard Oncology Center, Moncton, New Brunswick, Canada
Centre for Clinical Research Cancer Care Program, Halifax, Nova Scotia, Canada
Jaravinski Cancer Centre Hamilton Health Services, Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario, Kingston, Ontario, Canada
London Regional Cancer Program, London, Ontario, Canada
The Ottawa Hospital Regional Cancer Centre, Ottawa, Ontario, Canada
Regional Cancer Program de l'Hopital Regional de Sudbury, Sudbury, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada
Windsor Regional Cancer Centre, Windsor, Ontario, Canada
McGill University, Montreal, Quebec, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Institute of Radiation Oncology of Teaching Hospital Na Bulovce, Prague, , Czech Republic
Department of Radiation and Oncology of Teaching Hospital Motol, Prague, , Czech Republic
Teaching Hospital Kralovske Vinohrady, Prague, , Czech Republic
Clinical Center Niš - Clinic of Urology, Belgrade, , Former Serbia and Montenegro
Universitätsklinikum Köln, Köln, 50931, Germany
Gemeinschaftspraxis für Hämatologie & Onkologie, Augsburg, , Germany
Facharzt f. Urologie, Bad Schwartau, , Germany
Urologische Praxis, Bautzen, , Germany
Universitatsmedizin Charité, Berlin, , Germany
Klinik am Urban, Berlin, , Germany
Universitätsmedizin Charité Campus Benjamin Franklin, Berlin, , Germany
Urologische Praxis, Berlin, , Germany
Städtisches Klinikum Braunschweig, Braunschweig, , Germany
Facharzt f. Urologie, Cottbus, , Germany
Urologische Klinik, Dresden, , Germany
Universitäsklinikum Düsseldorf, Düsseldorf, , Germany
Urologische Klinik der Universitätsklink Düsseldorf, Düsseldorf, , Germany
Universitätsklinikum Essen, Essen, , Germany
Klinikum Fulda, Urologische Klinik, Fulda, , Germany
Urologische Praxis, Hagenow, , Germany
Urologische Gemeinschaftspraxis, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Nationales Centrum für Tumorerkrankungen, Heidelberg, , Germany
Universitätsklinikum Homburg/Saar, Homburg, , Germany
Klinikum Kassel GmbH, Kassel, , Germany
Gemeinschaftspraxis für Urologie, Kirchheim/Teck, , Germany
Gesellschaft f. klinische Studien und Urologisches Gesundheitszentrum, Leipzig, , Germany
Oberarzt d. Urolog. Abteilung, München, , Germany
Obearzt der Urologischen Klinik, Universitätsklinik Münster, Münster, , Germany
Praxisgemeinschaft für Onkologie und Urologie, Wilhelmshaven, , Germany
Gemeinschaftspraxis f. Urologie, Wuppertal, , Germany
Urologische Praxis, Zwickau, , Germany
IRM Center Hospital and Institutes, II.Department of Oncology, Budapest, , Hungary
Uzsoki Hospital of the Local Authority of Budapest, Oncoradiology, Budapest, , Hungary
University of Debrecen, Medical and Health Science Center, Department of Oncology, Debrecen, , Hungary
University of Szeged, Szent-Györgyi Albert Medical and Pharmacist Science Center, Clinic of Oncotherapy, Szeged, , Hungary
San Juan VA Medical Center, Reseach Dept, San Juan, , Puerto Rico
Cabinetul de Urologie, Arad, , Romania
Policlinica de diagnostic rapid, Brasov, , Romania
Institutul Oncologic Bucuresti, Bucuresti, , Romania
Euro S.R.L., Cluj Napoca, , Romania
ProVita 2000, Constanta, , Romania
Theaching Hospital of F.D. Roosevelt, Banska Bystrica, , Slovakia
Faculty Hospital Martin, Martin, , Slovakia
Faculty Hospital of J. A. Reiman, Presov, , Slovakia
Contact Details
Name: Howard I. Scher, MD
Affiliation: Sidney Kimmel Center for Prostate and Urologic Cancers, Memorial Sloan Kettering Cancer Center
Role: STUDY_CHAIR
Name: Kim N. Chi, M.D.
Affiliation: British Columbia Cancer Agency - Vancouver Centre
Role: STUDY_CHAIR
Name: Ronald De-Wit, M.D.
Affiliation: Erasmus University Medical Center (Netherlands)
Role: STUDY_CHAIR
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