DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (AIPC Study of Calcitriol Enhancing Taxotere [ASCENT-2])
- Conditions
- Prostate Cancer
- Registration Number
- NCT00273338
- Lead Sponsor
- Novacea
- 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
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 1200
- Histopathologically or cytologically proven adenocarcinoma of the prostate
- Documented metastatic prostate adenocarcinoma
- Documented progression while on androgen ablation therapy detected by rising prostate specific antigen (PSA) and/or imaging
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status <= 2
- Adequate hematologic, renal and hepatic function
- Life expectancy >= 3 months
- Prior chemotherapy, except estramustine
- Prior chemotherapy with docetaxel
- Prior isotope therapy (e.g., strontium-89, samarium-153, etc.)
- One or more contraindications to the use of corticosteroids
- History of cancer-related hypercalcemia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (212)
UCLA department of Urology
๐บ๐ธLos Angeles, California, United States
Hematology Oncology Associates of Illinois
๐บ๐ธChicago, Illinois, United States
The Cleveland Clinic Foundation
๐บ๐ธCleveland, Ohio, United States
Texas Cancer Center ar Medical City
๐บ๐ธDallas, Texas, United States
Center for Oncology Research and Treatment, PA
๐บ๐ธDallas, Texas, United States
Premiere Oncology of Arizona
๐บ๐ธScottsdale, Arizona, United States
North Broward Medical Center
๐บ๐ธDeerfield Beach, Florida, United States
Oncology Specialists
๐บ๐ธPark Ridge, Illinois, United States
Northern Arizona Hematology & Oncology Associates, AOA
๐บ๐ธSedona, Arizona, United States
Pasco Hernando Oncology Associates, P.A.
๐บ๐ธ14529 Cortez Blvd., Florida, United States
The Angeles Clinic and Research Institute, Inc.
๐บ๐ธLos Angeles, California, United States
Alaska Clinical Research Center
๐บ๐ธAnchorage, Alaska, United States
U of Arizona / Arizona Cancer Center
๐บ๐ธTucson, Arizona, United States
Atlanta Cancer Care
๐บ๐ธAtlanta, Georgia, United States
Tower Cancer Research Foundation
๐บ๐ธBeverly Hills, California, United States
Ocala Oncology Center
๐บ๐ธOcala, Florida, United States
Monterey Bay Oncology
๐บ๐ธMonterey, California, United States
Georgetown University Lombardi Cancer Center
๐บ๐ธWashington, District of Columbia, United States
Integrated Community Oncology Network
๐บ๐ธJacksonville, Florida, United States
Raleigh Hematology Oncology Associates
๐บ๐ธCary, North Carolina, United States
Cancer Care & Hematology Specialists of Chicagoland
๐บ๐ธNiles, Illinois, United States
Michael and Dianne Bienes Comprehensive Cancer Center
๐บ๐ธFt. Lauderdale, Florida, United States
Hematology Oncology Associates of
๐บ๐ธNew City, New York, United States
Nebraska Hematology-Oncology, PC
๐บ๐ธLincoln, Nebraska, United States
Maryland Oncology Hematology, P.A.
๐บ๐ธColumbia, Maryland, United States
Frederick Memorial Hospital
๐บ๐ธFrederick, Maryland, United States
Innovative Medical Research of South Florida Inc.
๐บ๐ธN. Miami Beach, Florida, United States
Park Nicollet Institute
๐บ๐ธSt. Louis Park, Minnesota, United States
Veterans Affairs Northern California Health Care System
๐บ๐ธMartinez, California, United States
Broward Oncology Associates
๐บ๐ธFt. Lauderdale, Florida, United States
Florida Cancer Specialists
๐บ๐ธFort Myers, Florida, United States
Midwest Prostate & Urology Health Center
๐บ๐ธChicago, Illinois, United States
Interlakes Foundation Inc.
๐บ๐ธRochester, New York, United States
Maine Center for Cancer Medicine & Blood Disorders
๐บ๐ธScarborough, Maine, United States
Cancer Centers of Florida, P.A.
๐บ๐ธOcoee, Florida, United States
Medical Center of Vincennes
๐บ๐ธVincennes, Indiana, United States
St. Joseph Oncology, Inc.
๐บ๐ธSt. Joseph, Missouri, United States
Aultman Hospital
๐บ๐ธCanton, Ohio, United States
Mid Ohio Oncology/Hematology, Inc.
๐บ๐ธColumbus, Ohio, United States
Medical Consultants, PC c/o Ball Cancer Center
๐บ๐ธMuncie, Indiana, United States
Southwest Cancer Treatment and Research Center
๐บ๐ธLubbock, Texas, United States
St. Mary Medical Center
๐บ๐ธLanghorne, Pennsylvania, United States
Texas Cancer Center- Sherman
๐บ๐ธSherman, Texas, United States
New Mexico Cancer Care Associates
๐บ๐ธSante Fe, New Mexico, United States
Northern Indiana Cancer Research Consortium
๐บ๐ธSouth Bend, Indiana, United States
Siouxland Hematology-Oncology Associates
๐บ๐ธSioux City, Iowa, United States
Memorial Sloan-Kett
๐บ๐ธNew York, New York, United States
Gabrail Cancer Center
๐บ๐ธCanton, Ohio, United States
Greater Philadelphia Cancer
๐บ๐ธPhiladelphia, Pennsylvania, United States
Univeristy of Pittsburgh Cancer Institute
๐บ๐ธPittsburgh, Pennsylvania, United States
The Texas Cancer Center
๐บ๐ธDallas, Texas, United States
The Center for Cancer & Blood Disorders
๐บ๐ธFort Worth, Texas, United States
Chattanooga Oncology & Hematology Assoc.
๐บ๐ธChattanooga, Tennessee, United States
Staten Island Urological Research, PC
๐บ๐ธStaten Island, New York, United States
Urology Associates of North Texas (UANT)
๐บ๐ธArlington, Texas, United States
The Valley Hospital
๐บ๐ธParamus, New Jersey, United States
Texas Cancer Center-Abilene
๐บ๐ธAbilene, Texas, United States
Dakota Cancer Institute
๐บ๐ธFargo, North Dakota, United States
Texas Oncology, PA
๐บ๐ธAmarillo, Texas, United States
Horizon's West Medical Group
๐บ๐ธScottsbluff, Nebraska, United States
Wenatchee Valley Medical Center
๐บ๐ธWenatchee, Washington, United States
Allison Cancer Center
๐บ๐ธMidland, Texas, United States
Texas Cancer Center
๐บ๐ธArlington, Texas, United States
Paris Regional Cancer Center
๐บ๐ธParis, Texas, United States
British Columbia Cancer Agency - Vancouver Island Centre
๐จ๐ฆVictoria, British Columbia, Canada
Texas Oncology Cancer Center
๐บ๐ธAustin, Texas, United States
Cancer Centers of the Carolina
๐บ๐ธGreenville, South Carolina, United States
Texas Oncology Cancer Care and Research Center
๐บ๐ธWaco, Texas, United States
Klinikum Fulda, Urologische Klinik
๐ฉ๐ชFulda, Germany
Puget Sound Cancer Centers
๐บ๐ธSeattle, Washington, United States
Centre for Clinical Research Cancer Care Program
๐จ๐ฆHalifax, Nova Scotia, Canada
Virginia Oncology Associates
๐บ๐ธNorfolk, Virginia, United States
Jaravinski Cancer Centre Hamilton Health Services
๐จ๐ฆHamilton, Ontario, Canada
Klinik am Urban
๐ฉ๐ชBerlin, Germany
Praxisgemeinschaft fรผr Onkologie und Urologie
๐ฉ๐ชWilhelmshaven, Germany
Texas Oncology
๐บ๐ธWaco, Texas, United States
Northwest Cancer Specialists, P.C.
๐บ๐ธVancouver, Washington, United States
Texas Oncology Cancer Center-Sugar Land
๐บ๐ธSugar Land, Texas, United States
Urologische Klinik der Universitรคtsklink Dรผsseldorf
๐ฉ๐ชDรผsseldorf, Germany
Facharzt f. Urologie
๐ฉ๐ชCottbus, Germany
University of Debrecen, Medical and Health Science Center, Department of Oncology
๐ญ๐บDebrecen, Hungary
Urologische Praxis
๐ฉ๐ชZwickau, Germany
Oberarzt d. Urolog. Abteilung
๐ฉ๐ชMรผnchen, Germany
Cancer Care Manitoba
๐จ๐ฆWinnipeg, Manitoba, Canada
Cancer Centre of Southeastern Ontario
๐จ๐ฆKingston, Ontario, Canada
Gemeinschaftspraxis f. Urologie
๐ฉ๐ชWuppertal, Germany
Medizinische Hochschule Hannover
๐ฉ๐ชHannover, Germany
Department of Radiation and Oncology of Teaching Hospital Motol
๐จ๐ฟPrague, Czech Republic
Urologische Gemeinschaftspraxis
๐ฉ๐ชHamburg, Germany
Universitรคsklinikum Dรผsseldorf
๐ฉ๐ชDรผsseldorf, Germany
Universitรคtsklinikum Essen
๐ฉ๐ชEssen, Germany
Policlinica de diagnostic rapid
๐ท๐ดBrasov, Romania
Uzsoki Hospital of the Local Authority of Budapest, Oncoradiology
๐ญ๐บBudapest, Hungary
Sharp Memorial Hospital
๐บ๐ธSan Diego, California, United States
Minnesota Oncology Hematology, P.A.
๐บ๐ธMinneapolis, Minnesota, United States
MN Cooperative Group Outreach Prg.
๐บ๐ธMinneapolis, Minnesota, United States
Nevada Cancer Institute
๐บ๐ธLas Vegas, Nevada, United States
Oncology Hematology Care, Inc.
๐บ๐ธCincinnati, Ohio, United States
South Texas Oncology and Hematology, PA
๐บ๐ธSan Antonio, Texas, United States
InVisions Consultants LLC
๐บ๐ธSan Antonio, Texas, United States
Sarah Cannon Research Institute
๐บ๐ธNashville, Tennessee, United States
California Pacific Medical Center
๐บ๐ธSan Francisco, California, United States
Hematology Associates - AOA
๐บ๐ธPhoenix, Arizona, United States
Henry Ford Health System
๐บ๐ธDetroit, Michigan, United States
University of Oklahoma
๐บ๐ธOklahoma City, Oklahoma, United States
London Regional Cancer Program
๐จ๐ฆLondon, Ontario, Canada
The Ottawa Hospital Regional Cancer Centre
๐จ๐ฆOttawa, Ontario, Canada
Regional Cancer Program de l'Hopital Regional de Sudbury
๐จ๐ฆSudbury, Ontario, Canada
Windsor Regional Cancer Centre
๐จ๐ฆWindsor, Ontario, Canada
Klinikum Kassel GmbH
๐ฉ๐ชKassel, Germany
Rocky Mountain Cancer Centers
๐บ๐ธColorado Springs, Colorado, United States
Central Indiana Cancer Centers
๐บ๐ธIndianapolis, Indiana, United States
Hematology Oncology Life Center
๐บ๐ธAlexandria, Louisiana, United States
Peachtree Hematology-Oncology Consultants, PC
๐บ๐ธAtlanta, Georgia, United States
Phoebe Cancer Center
๐บ๐ธAlbany, Georgia, United States
Northeast GA Medical Center
๐บ๐ธGainesville, Georgia, United States
Georgia Cancer Specialist
๐บ๐ธTucker, Georgia, United States
Cancer Care Network of South Texas, HOAST
๐บ๐ธNew Braunfels, Texas, United States
Swedish American Regional Cancer Center
๐บ๐ธRockford, Illinois, United States
Iowa Cancer Care
๐บ๐ธCedar Rapids, Iowa, United States
Overlook Oncology Center
๐บ๐ธSummit, New Jersey, United States
Cancer Care Associates
๐บ๐ธTulsa, Oklahoma, United States
Willamette Valley Cancer Center
๐บ๐ธEugene, Oregon, United States
Medical Oncology Associates of Wyoming Valley, PC
๐บ๐ธKingston, Pennsylvania, United States
Toronto Sunnybrook Regional Cancer Centre
๐จ๐ฆToronto, Ontario, Canada
Pottsville Cancer Care
๐บ๐ธPottsville, Pennsylvania, United States
Nationales Centrum fรผr Tumorerkrankungen
๐ฉ๐ชHeidelberg, Germany
Guthrie Clinic
๐บ๐ธSayre, Pennsylvania, United States
South Carolina Cancer Specialists
๐บ๐ธHilton Head Island, South Carolina, United States
MamieMcFaddin Ward Cancer Center
๐บ๐ธBeaumont, Texas, United States
Texas Cancer Center of Mesquite
๐บ๐ธMesquite, Texas, United States
Oncology & Hematology Associates of Southwest Virginia, Inc.
๐บ๐ธSalem, Virginia, United States
Universitรคtsklinikum Homburg/Saar
๐ฉ๐ชHomburg, Germany
Northwest Alabama Cancer Center
๐บ๐ธMuscle Shoals, Alabama, United States
Pacific Shores Medical Group
๐บ๐ธLong Beach, California, United States
Sutter Gould Medical Foundation
๐บ๐ธModesto, California, United States
Gainesville Hematology Oncology Associates
๐บ๐ธGainesville, Florida, United States
Stanford University
๐บ๐ธStanford, California, United States
University of Florida Shands Cancer Center
๐บ๐ธGainesville, Florida, United States
Sylvester Comprehensive Cancer Center, U of Miami
๐บ๐ธMiami, Florida, United States
AYS Urology
๐บ๐ธTrinity, Florida, United States
South Georgia Medical Center
๐บ๐ธValdosta, Georgia, United States
Hematology Oncology Associates of Illinois, L.L.C
๐บ๐ธSkokie, Illinois, United States
Hope Center
๐บ๐ธTerre Haute, Indiana, United States
St. Agnes Health System
๐บ๐ธBaltimore, Maryland, United States
Mercy Medical Center, North Iowa
๐บ๐ธMason City, Iowa, United States
Missouri Cancer Associates
๐บ๐ธColumbia, Missouri, United States
University of Missouri, Ellis Fischel Cancer Center
๐บ๐ธColumbia, Missouri, United States
University of Rochester Medical Center
๐บ๐ธRochester, New York, United States
Comprehensive Cancer Centers of Nevada
๐บ๐ธLas Vegas, Nevada, United States
UMDNJ-Newark
๐บ๐ธNewark, New Jersey, United States
Carolina Cancer Management, Inc.
๐บ๐ธFayetteville, North Carolina, United States
SUNY Downstate Medical Center
๐บ๐ธBrooklyn, New York, United States
Hematology & Oncology Associates of Northeastern PA
๐บ๐ธDunmore, Pennsylvania, United States
Dayton Oncology & Hematology, P.A.
๐บ๐ธKettering, Ohio, United States
Consultants in Medical Oncology & Hematology
๐บ๐ธDrexel Hill, Pennsylvania, United States
The Jones Clinic
๐บ๐ธGermantown, Tennessee, United States
Texas Oncology, P.A.
๐บ๐ธLongview, Texas, United States
Lake Vista Cancer Center
๐บ๐ธLewisville, Texas, United States
South Texas Cancer Center - McAllen
๐บ๐ธMcAllen, Texas, United States
West Texas Cancer Center
๐บ๐ธOdessa, Texas, United States
Fairfax Northern Virginia Hematology OnCology, PC
๐บ๐ธFairfax, Virginia, United States
Tom Baker Cancer Center-Medical Oncology
๐จ๐ฆCalgary, Alberta, Canada
Cross Cancer Institute
๐จ๐ฆEdmonton, Alberta, Canada
McGill University
๐จ๐ฆMontreal, Quebec, Canada
The Moncton Hospital (SERHA)
๐จ๐ฆMoncton, New Brunswick, Canada
Stรคdtisches Klinikum Braunschweig
๐ฉ๐ชBraunschweig, Germany
Urologische Klinik
๐ฉ๐ชDresden, Germany
Institute of Radiation Oncology of Teaching Hospital Na Bulovce
๐จ๐ฟPrague, Czech Republic
Saskatoon Cancer Centre
๐จ๐ฆSaskatoon, Saskatchewan, Canada
Clinical Center Niลก - Clinic of Urology
Belgrade, Former Serbia and Montenegro
Universitรคtsklinikum Kรถln
๐ฉ๐ชKรถln, 50931, Germany
Gemeinschaftspraxis fรผr Hรคmatologie & Onkologie
๐ฉ๐ชAugsburg, Germany
Universitatsmedizin Charitรฉ
๐ฉ๐ชBerlin, Germany
Universitรคtsmedizin Charitรฉ Campus Benjamin Franklin
๐ฉ๐ชBerlin, Germany
Gemeinschaftspraxis fรผr Urologie
๐ฉ๐ชKirchheim/Teck, Germany
Obearzt der Urologischen Klinik, Universitรคtsklinik Mรผnster
๐ฉ๐ชMรผnster, Germany
Gesellschaft f. klinische Studien und Urologisches Gesundheitszentrum
๐ฉ๐ชLeipzig, Germany
Faculty Hospital Martin
๐ธ๐ฐMartin, Slovakia
Cabinetul de Urologie
๐ท๐ดArad, Romania
Teaching Hospital Kralovske Vinohrady
๐จ๐ฟPrague, Czech Republic
BCCA-Centre for the Southern Interior
๐จ๐ฆKelowna, British Columbia, Canada
ProVita 2000
๐ท๐ดConstanta, Romania
BCCA-Vancouver
๐จ๐ฆVancouver, British Columbia, Canada
IRM Center Hospital and Institutes, II.Department of Oncology
๐ญ๐บBudapest, Hungary
Institutul Oncologic Bucuresti
๐ท๐ดBucuresti, Romania
Euro S.R.L.
๐ท๐ดCluj Napoca, Romania
San Juan VA Medical Center, Reseach Dept
๐ต๐ทSan Juan, Puerto Rico
Faculty Hospital of J. A. Reiman
๐ธ๐ฐPresov, Slovakia
University of Washington
๐บ๐ธSeattle, Washington, United States
Dr. Leon Richard Oncology Center
๐จ๐ฆMoncton, New Brunswick, Canada
Theaching Hospital of F.D. Roosevelt
๐ธ๐ฐBanska Bystrica, Slovakia
University of Szeged, Szent-Gyรถrgyi Albert Medical and Pharmacist Science Center, Clinic of Oncotherapy
๐ญ๐บSzeged, Hungary
Birmingham Hematology & Oncology Associates, LLC
๐บ๐ธBirmingham, Alabama, United States
Sutter Cancer Center
๐บ๐ธSacramento, California, United States
UCD Cancer Center-Clinical Trials
๐บ๐ธSacramento, California, United States
Nebraska Methodist Hospital - Oncology Research Dept
๐บ๐ธOmaha, Nebraska, United States
Piedmont Hematology Oncology Associates, PLLC
๐บ๐ธWinston-Salem, North Carolina, United States
Charleston Cancer Center
๐บ๐ธCharleston, South Carolina, United States
Medical University Of South Carolina
๐บ๐ธCharleston, South Carolina, United States
Medical College of Wisconsin
๐บ๐ธMilwaukee, Wisconsin, United States
Charleston Hematology Oncology PA
๐บ๐ธCharleston, South Carolina, United States
Southern Arizona VA Healthcare System
๐บ๐ธTucson, Arizona, United States
Florida Cancer Institute
๐บ๐ธNew Port Richey, Florida, United States
Highline Medical Oncology
๐บ๐ธBurien, Washington, United States
Pasco Hernando Oncology Associates P.A.
๐บ๐ธNew Port Richey, Florida, United States
El Paso Cancer Treatment Center-East
๐บ๐ธEl Paso, Texas, United States
Yakima Valley Memorial Hospital/North Star Lodge
๐บ๐ธYakima, Washington, United States
Genesis Cancer Center
๐บ๐ธHot Springs, Arkansas, United States
Comprehensive Cancer Center at
๐บ๐ธPalm Springs, California, United States
Northeast Georgia Cancer Care, LLC
๐บ๐ธAthens, Georgia, United States
University of Kansas Medical Center
๐บ๐ธKansas City, Kansas, United States