DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (AIPC Study of Calcitriol Enhancing Taxotere [ASCENT-2])

Prostate Cancer Clinical Trial

Official title:

A Phase 3, Randomized, Open-Label Study Evaluating DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (ASCENT-2)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00273338
• Other study ID #: 011-007
• Status: Terminated
• Phase: Phase 3
• First received: December 14, 2005
• Last updated: November 2, 2007
• Start date: January 2006
• Est. completion date: November 2007

Study information

• Verified date: November 2007
• Source: Novacea
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1200
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• calcitriol

• docetaxel

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Center-Medical Oncology	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Centre for Clinical Research Cancer Care Program	Halifax	Nova Scotia
Canada	Jaravinski Cancer Centre Hamilton Health Services	Hamilton	Ontario
Canada	BCCA-Centre for the Southern Interior	Kelowna	British Columbia
Canada	Cancer Centre of Southeastern Ontario	Kingston	Ontario
Canada	London Regional Cancer Program	London	Ontario
Canada	Dr. Leon Richard Oncology Center	Moncton	New Brunswick
Canada	The Moncton Hospital (SERHA)	Moncton	New Brunswick
Canada	McGill University	Montreal	Quebec
Canada	The Ottawa Hospital Regional Cancer Centre	Ottawa	Ontario
Canada	Saskatoon Cancer Centre	Saskatoon	Saskatchewan
Canada	Regional Cancer Program de l'Hopital Regional de Sudbury	Sudbury	Ontario
Canada	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario
Canada	BCCA-Vancouver	Vancouver	British Columbia
Canada	British Columbia Cancer Agency - Vancouver Island Centre	Victoria	British Columbia
Canada	Windsor Regional Cancer Centre	Windsor	Ontario
Canada	Cancer Care Manitoba	Winnipeg	Manitoba
Czech Republic	Department of Radiation and Oncology of Teaching Hospital Motol	Prague
Czech Republic	Institute of Radiation Oncology of Teaching Hospital Na Bulovce	Prague
Czech Republic	Teaching Hospital Kralovske Vinohrady	Prague
Former Serbia and Montenegro	Clinical Center Niš - Clinic of Urology	Belgrade
Germany	Gemeinschaftspraxis für Hämatologie & Onkologie	Augsburg
Germany	Facharzt f. Urologie	Bad Schwartau
Germany	Urologische Praxis	Bautzen
Germany	Klinik am Urban	Berlin
Germany	Universitatsmedizin Charité	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	Universitätsklinikum Köln	Köln	50931
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
Hungary	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
Puerto Rico	San Juan VA Medical Center, Reseach Dept	San Juan
Romania	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
Slovakia	Theaching Hospital of F.D. Roosevelt	Banska Bystrica
Slovakia	Faculty Hospital Martin	Martin
Slovakia	Faculty Hospital of J. A. Reiman	Presov
United States	Pasco Hernando Oncology Associates, P.A.	14529 Cortez Blvd.	Florida
United States	Texas Cancer Center-Abilene	Abilene	Texas
United States	Phoebe Cancer Center	Albany	Georgia
United States	Hematology Oncology Life Center	Alexandria	Louisiana
United States	Texas Oncology, PA	Amarillo	Texas
United States	Alaska Clinical Research Center	Anchorage	Alaska
United States	Texas Cancer Center	Arlington	Texas
United States	Urology Associates of North Texas (UANT)	Arlington	Texas
United States	Northeast Georgia Cancer Care, LLC	Athens	Georgia
United States	Atlanta Cancer Care	Atlanta	Georgia
United States	Peachtree Hematology-Oncology Consultants, PC	Atlanta	Georgia
United States	Texas Oncology Cancer Center	Austin	Texas
United States	St. Agnes Health System	Baltimore	Maryland
United States	MamieMcFaddin Ward Cancer Center	Beaumont	Texas
United States	Tower Cancer Research Foundation	Beverly Hills	California
United States	Birmingham Hematology & Oncology Associates, LLC	Birmingham	Alabama
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Highline Medical Oncology	Burien	Washington
United States	Aultman Hospital	Canton	Ohio
United States	Gabrail Cancer Center	Canton	Ohio
United States	Raleigh Hematology Oncology Associates	Cary	North Carolina
United States	Iowa Cancer Care	Cedar Rapids	Iowa
United States	Charleston Cancer Center	Charleston	South Carolina
United States	Charleston Hematology Oncology PA	Charleston	South Carolina
United States	Medical University Of South Carolina	Charleston	South Carolina
United States	Chattanooga Oncology & Hematology Assoc.	Chattanooga	Tennessee
United States	Hematology Oncology Associates of Illinois	Chicago	Illinois
United States	Midwest Prostate & Urology Health Center	Chicago	Illinois
United States	Oncology Hematology Care, Inc.	Cincinnati	Ohio
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Rocky Mountain Cancer Centers	Colorado Springs	Colorado
United States	Maryland Oncology Hematology, P.A.	Columbia	Maryland
United States	Missouri Cancer Associates	Columbia	Missouri
United States	University of Missouri, Ellis Fischel Cancer Center	Columbia	Missouri
United States	Mid Ohio Oncology/Hematology, Inc.	Columbus	Ohio
United States	Center for Oncology Research and Treatment, PA	Dallas	Texas
United States	Texas Cancer Center ar Medical City	Dallas	Texas
United States	Texas Oncology, P.A.	Dallas	Texas
United States	The Texas Cancer Center	Dallas	Texas
United States	North Broward Medical Center	Deerfield Beach	Florida
United States	Henry Ford Health System	Detroit	Michigan
United States	Consultants in Medical Oncology & Hematology	Drexel Hill	Pennsylvania
United States	Hematology & Oncology Associates of Northeastern PA	Dunmore	Pennsylvania
United States	Puget Sound Cancer Centers	Edmonds	Washington
United States	El Paso Cancer Treatment Center-East	El Paso	Texas
United States	Willamette Valley Cancer Center	Eugene	Oregon
United States	Fairfax Northern Virginia Hematology OnCology, PC	Fairfax	Virginia
United States	Dakota Cancer Institute	Fargo	North Dakota
United States	Carolina Cancer Management, Inc.	Fayetteville	North Carolina
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Texas Oncology, P.A.	Fort Worth	Texas
United States	The Center for Cancer & Blood Disorders	Fort Worth	Texas
United States	Frederick Memorial Hospital	Frederick	Maryland
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	Northeast GA Medical Center	Gainesville	Georgia
United States	University of Florida Shands Cancer Center	Gainesville	Florida
United States	Texas Oncology, P.A.	Garland	Texas
United States	The Jones Clinic	Germantown	Tennessee
United States	Cancer Centers of the Carolina	Greenville	South Carolina
United States	South Carolina Cancer Specialists	Hilton Head Island	South Carolina
United States	Genesis Cancer Center	Hot Springs	Arkansas
United States	Texas Oncology, P.A.	Houston	Texas
United States	Central Indiana Cancer Centers	Indianapolis	Indiana
United States	Integrated Community Oncology Network	Jacksonville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Dayton Oncology & Hematology, P.A.	Kettering	Ohio
United States	Medical Oncology Associates of Wyoming Valley, PC	Kingston	Pennsylvania
United States	St. Mary Medical Center	Langhorne	Pennsylvania
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Nevada Cancer Institute	Las Vegas	Nevada
United States	Lake Vista Cancer Center	Lewisville	Texas
United States	Nebraska Hematology-Oncology, PC	Lincoln	Nebraska
United States	Pacific Shores Medical Group	Long Beach	California
United States	Texas Oncology, P.A.	Longview	Texas
United States	The Angeles Clinic and Research Institute, Inc.	Los Angeles	California
United States	UCLA department of Urology	Los Angeles	California
United States	Southwest Cancer Treatment and Research Center	Lubbock	Texas
United States	Veterans Affairs Northern California Health Care System	Martinez	California
United States	Mercy Medical Center, North Iowa	Mason City	Iowa
United States	South Texas Cancer Center - McAllen	McAllen	Texas
United States	Texas Cancer Center of Mesquite	Mesquite	Texas
United States	Sylvester Comprehensive Cancer Center, U of Miami	Miami	Florida
United States	Allison Cancer Center	Midland	Texas
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Minnesota Oncology Hematology, P.A.	Minneapolis	Minnesota
United States	MN Cooperative Group Outreach Prg.	Minneapolis	Minnesota
United States	Sutter Gould Medical Foundation	Modesto	California
United States	Monterey Bay Oncology	Monterey	California
United States	Medical Consultants, PC c/o Ball Cancer Center	Muncie	Indiana
United States	Northwest Alabama Cancer Center	Muscle Shoals	Alabama
United States	Innovative Medical Research of South Florida Inc.	N. Miami Beach	Florida
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Cancer Care Network of South Texas, HOAST	New Braunfels	Texas
United States	Hematology Oncology Associates of	New City	New York
United States	Florida Cancer Institute	New Port Richey	Florida
United States	Pasco Hernando Oncology Associates P.A.	New Port Richey	Florida
United States	Memorial Sloan-Kett	New York	New York
United States	UMDNJ-Newark	Newark	New Jersey
United States	Cancer Care & Hematology Specialists of Chicagoland	Niles	Illinois
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Ocala Oncology Center	Ocala	Florida
United States	Cancer Centers of Florida, P.A.	Ocoee	Florida
United States	West Texas Cancer Center	Odessa	Texas
United States	Cancer Care Associates	Oklahoma City	Oklahoma
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	Nebraska Methodist Hospital - Oncology Research Dept	Omaha	Nebraska
United States	Comprehensive Cancer Center at	Palm Springs	California
United States	The Valley Hospital	Paramus	New Jersey
United States	Paris Regional Cancer Center	Paris	Texas
United States	Oncology Specialists	Park Ridge	Illinois
United States	Greater Philadelphia Cancer	Philadelphia	Pennsylvania
United States	Hematology Associates - AOA	Phoenix	Arizona
United States	Univeristy of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	Pottsville Cancer Care	Pottsville	Pennsylvania
United States	Interlakes Foundation Inc.	Rochester	New York
United States	University of Rochester Medical Center	Rochester	New York
United States	Swedish American Regional Cancer Center	Rockford	Illinois
United States	Sutter Cancer Center	Sacramento	California
United States	UCD Cancer Center-Clinical Trials	Sacramento	California
United States	Park Nicollet Institute	Saint Louis Park	Minnesota
United States	Oncology & Hematology Associates of Southwest Virginia, Inc.	Salem	Virginia
United States	InVisions Consultants LLC	San Antonio	Texas
United States	South Texas Oncology and Hematology, PA	San Antonio	Texas
United States	Sharp Memorial Hospital	San Diego	California
United States	California Pacific Medical Center	San Francisco	California
United States	New Mexico Cancer Care Associates	Sante Fe	New Mexico
United States	Guthrie Clinic	Sayre	Pennsylvania
United States	Maine Center for Cancer Medicine & Blood Disorders	Scarborough	Maine
United States	Horizon's West Medical Group	Scottsbluff	Nebraska
United States	Premiere Oncology of Arizona	Scottsdale	Arizona
United States	Puget Sound Cancer Centers	Seattle	Washington
United States	University of Washington	Seattle	Washington
United States	Northern Arizona Hematology & Oncology Associates, AOA	Sedona	Arizona
United States	Texas Cancer Center- Sherman	Sherman	Texas
United States	Siouxland Hematology-Oncology Associates	Sioux City	Iowa
United States	Hematology Oncology Associates of Illinois, L.L.C	Skokie	Illinois
United States	Northern Indiana Cancer Research Consortium	South Bend	Indiana
United States	St. Joseph Oncology, Inc.	St. Joseph	Missouri
United States	Park Nicollet Institute	St. Louis Park	Minnesota
United States	Stanford University	Stanford	California
United States	Staten Island Urological Research, PC	Staten Island	New York
United States	Texas Oncology Cancer Center-Sugar Land	Sugar Land	Texas
United States	Overlook Oncology Center	Summit	New Jersey
United States	Hope Center	Terre Haute	Indiana
United States	AYS Urology	Trinity	Florida
United States	Georgia Cancer Specialist	Tucker	Georgia
United States	Southern Arizona VA Healthcare System	Tucson	Arizona
United States	U of Arizona / Arizona Cancer Center	Tucson	Arizona
United States	Cancer Care Associates	Tulsa	Oklahoma
United States	South Georgia Medical Center	Valdosta	Georgia
United States	Northwest Cancer Specialists, P.C.	Vancouver	Washington
United States	Medical Center of Vincennes	Vincennes	Indiana
United States	Texas Oncology	Waco	Texas
United States	Texas Oncology Cancer Care and Research Center	Waco	Texas
United States	Georgetown University Lombardi Cancer Center	Washington	District of Columbia
United States	Wenatchee Valley Medical Center	Wenatchee	Washington
United States	Piedmont Hematology Oncology Associates, PLLC	Winston-Salem	North Carolina
United States	Yakima Valley Memorial Hospital/North Star Lodge	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Novacea

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  Former Serbia and Montenegro,  Germany,  Hungary,  Puerto Rico,  Romania,  Slovakia,