Clinical trial NCT00273338: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Androgen-independent Prostate Cancer (AIPC)
Prostate Cancer
DN-101
calcitriol
Taxotere
docetaxel
Lead sponsor: Novacea
Sponsor class: INDUSTRY
First posted: 2006-01-09
Enrollment: 1200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

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