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)
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.
Status | Terminated |
Enrollment | 1200 |
Est. completion date | November 2007 |
Est. primary completion date | |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Novacea |
United States, Canada, Czech Republic, Former Serbia and Montenegro, Germany, Hungary, Puerto Rico, Romania, Slovakia,
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