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


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Howard I. Scher, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Center for Prostate and Urologic Cancers, Memorial Sloan Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

011-007

NCT ID:

NCT00273338

Start Date:

January 2006

Completion Date:

November 2007

Related Keywords:

  • Prostate Cancer
  • Androgen-independent Prostate Cancer (AIPC)
  • Prostate Cancer
  • DN-101
  • calcitriol
  • Taxotere
  • docetaxel
  • Prostatic Neoplasms

Name

Location

Medical University of South Carolina Charleston, South Carolina  29425-0721
Medical College of Wisconsin Milwaukee, Wisconsin  53226
Stanford University Stanford, California  94305
South Georgia Medical Center Valdosta, Georgia  31603
Texas Oncology, P.A. Dallas, Texas  75246
University of Kansas Medical Center Kansas City, Kansas  66160-7353
University of Rochester Medical Center Rochester, New York  14642
Sutter Cancer Center Sacramento, California  95816
Dakota Cancer Institute Fargo, North Dakota  58103-4940
SUNY Downstate Medical Center Brooklyn, New York  11203
Virginia Oncology Associates Newport News, Virginia  23606
University of Florida Shands Cancer Center Gainesville, Florida  32610-0232
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada  89109
Siouxland Hematology-Oncology Associates Sioux City, Iowa  51101
Ocala Oncology Center Ocala, Florida  34474
Florida Cancer Specialists Fort Myers, Florida  33901
Missouri Cancer Associates Columbia, Missouri  65201
University of Oklahoma Oklahoma City, Oklahoma  73190
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Pacific Shores Medical Group Long Beach, California  90813
Rocky Mountain Cancer Centers Thornton, Colorado  80260
Sharp Memorial Hospital San Diego, California  92123
Sutter Gould Medical Foundation Modesto, California  95353
New Mexico Cancer Care Associates Santa Fe, New Mexico  87505-7670
University of Washington Seattle, Washington  98195
Integrated Community Oncology Network Jacksonville Beach, Florida  32250
Atlanta Cancer Care Atlanta, Georgia  30342
Genesis Cancer Center Hot Springs, Arkansas  71913
Hope Center Terre Haute, Indiana  47809
Cancer Care Associates Tulsa, Oklahoma  74136
Willamette Valley Cancer Center Eugene, Oregon  97401-8122
Tower Cancer Research Foundation Beverly Hills, California  90211
St. Joseph Oncology, Inc. Saint Joseph, Missouri  64506
Henry Ford Health System Detroit, Michigan  48202
Georgia Cancer Specialist Marietta, Georgia  30060
Monterey Bay Oncology Monterey, California  93940
Charleston Cancer Center Charleston, South Carolina  29406
Broward Oncology Associates Ft. Lauderdale, Florida  33308
California Pacific Medical Center San Francisco, California  94115
Oncology Hematology Care, Inc. Cincinnati, Ohio  45219
Northeast Georgia Cancer Care, LLC Athens, Georgia  30607
The Cleveland Clinic Foundation Cleveland, Ohio  
Hematology Oncology Associates of Illinois Skokie, Illinois  60077
Cancer Centers of Florida, P.A. Orlando, Florida  
Texas Oncology Dallas, Texas  
Innovative Medical Research of South Florida Inc. Miami Shores, Florida  33138
Gabrail Cancer Center Canton, Ohio  44718
Maine Center for Cancer Medicine & Blood Disorders Scarborough, Maine  04074
Medical Center of Vincennes Vincennes, Indiana  47591
Texas Oncology, PA Dallas, Texas  75246-2006
Florida Cancer Institute New Port Richey, Florida  34652
Central Indiana Cancer Centers Indianapolis, Indiana  46227
Minnesota Oncology Hematology, P.A. Minneapolis, Minnesota  55407
Overlook Oncology Center Summit, New Jersey  07901
Medical Oncology Associates of Wyoming Valley, PC Kingston, Pennsylvania  18704
Allison Cancer Center Midland, Texas  79701
West Texas Cancer Center Odessa, Texas  79761
Southern Arizona VA Healthcare System Tucson, Arizona  85723
Frederick Memorial Hospital Frederick, Maryland  21701
Highline Medical Oncology Burien, Washington  98166
Consultants in Medical Oncology & Hematology Drexel Hill, Pennsylvania  19026
The Jones Clinic Germantown, Tennessee  38138
Mid Ohio Oncology/Hematology, Inc. Columbus, Ohio  43213
Horizon's West Medical Group Scottsbluff, Nebraska  69361
Northern Indiana Cancer Research Consortium South Bend, Indiana  
Alaska Clinical Research Center Anchorage, Alaska  99508
Staten Island Urological Research, PC Staten Island, New York  10304
Nevada Cancer Institute Las Vegas, Nevada  89135
Midwest Prostate & Urology Health Center Chicago, Illinois  60640
Piedmont Hematology Oncology Associates, PLLC Winston-Salem, North Carolina  
Northwest Cancer Specialists, P.C. Vancouver, Washington  
Texas Cancer Center Abilene, Texas  79606
Texas Oncology Cancer Center Austin, Texas  78731
The Texas Cancer Center Dallas, Texas  75237
Lake Vista Cancer Center Lewisville, Texas  75067
Texas Cancer Center of Mesquite Mesquite, Texas  75150
North Broward Medical Center Dearfield Beach, Florida  33064-3596
Raleigh Hematology Oncology Associates Cary, North Carolina  27511
Guthrie Clinic Sayre, Pennsylvania  18840
Center for Oncology Research and Treatment, PA Dallas, Texas  75230
Oncology Specialists Park Ridge, Illinois  60068
Puget Sound Cancer Centers Edmonds, Washington  98026
Maryland Oncology Hematology, P.A. Columbia, Maryland  21044
Dayton Oncology & Hematology, P.A. Kettering, Ohio  45409
South Texas Cancer Center - McAllen McAllen, Texas  78503-1298
Paris Regional Cancer Center Paris, Texas  75460
Fairfax Northern Virginia Hematology Oncology, PC Fairfax, Virginia  22031
Oncology & Hematology Associates of Southwest Virginia, Inc. Salem, Virginia  24153
Hematology Oncology Life Center Alexandria, Louisiana  71301
Medical Consultants, PC c/o Ball Cancer Center Muncie, Indiana  47303
Sarah Cannon Research Institute Nashville, Tennessee  37203
Northwest Alabama Cancer Center Muscle Shoals, Alabama  35661
Gainesville Hematology Oncology Associates Gainesville, Florida  32605
St. Mary Medical Center Langhorne, Pennsylvania  19047
South Carolina Cancer Specialists Hilton Head Island, South Carolina  29925
Park Nicollet Institute St Louis Park, Minnesota  55416
Nebraska Hematology-Oncology, PC Lincoln, Nebraska  68506
Phoebe Cancer Center Albany, Georgia  31701
Aultman Hospital Canton, Ohio  44710
Cancer Care & Hematology Specialists of Chicagoland Niles, Illinois  60714
Yakima Valley Memorial Hospital/North Star Lodge Yakima, Washington  98902
Texas Oncology Cancer Center-Sugar Land Sugar Land, Texas  77479
Premiere Oncology of Arizona Scottsdale, Arizona  85260
The Valley Hospital Paramus, New Jersey  07652
Birmingham Hematology & Oncology Associates, LLC Birmingham, Alabama  35223
Hematology Associates - AOA Phoenix, Arizona  85012
Northern Arizona Hematology & Oncology Associates, AOA Sedona, Arizona  86336
U of Arizona / Arizona Cancer Center Tucson, Arizona  85724
The Angeles Clinic and Research Institute, Inc. Los Angeles, California  90025
UCLA department of Urology Los Angeles, California  90095-1738
Veterans Affairs Northern California Health Care System Martinez, California  94553
Comprehensive Cancer Center at Palm Springs, California  92262
UCD Cancer Center-Clinical Trials Sacramento, California  95817
Georgetown University Lombardi Cancer Center Washington, District of Columbia  20007
Pasco Hernando Oncology Associates, P.A. 14529 Cortez Blvd., Florida  34613
Michael and Dianne Bienes Comprehensive Cancer Center Ft. Lauderdale, Florida  33308
Sylvester Comprehensive Cancer Center, U of Miami Miami, Florida  33136
Pasco Hernando Oncology Associates P.A. New Port Richey, Florida  34652
AYS Urology Trinity, Florida  34655
Peachtree Hematology-Oncology Consultants, PC Atlanta, Georgia  30309
Northeast GA Medical Center Gainesville, Georgia  30501
Swedish American Regional Cancer Center Rockford, Illinois  61104
Hematology Oncology Associates of Illinois, L.L.C Skokie, Illinois  60077
Iowa Cancer Care Cedar Rapids, Iowa  52403
Mercy Medical Center, North Iowa Mason City, Iowa  50401
St. Agnes Health System Baltimore, Maryland  21229
MN Cooperative Group Outreach Prg. Minneapolis, Minnesota  55407
University of Missouri, Ellis Fischel Cancer Center Columbia, Missouri  65203
Nebraska Methodist Hospital - Oncology Research Dept Omaha, Nebraska  68144
UMDNJ-Newark Newark, New Jersey  07101
Hematology Oncology Associates of New City, New York  10956
Memorial Sloan-Kett New York, New York  10021
Interlakes Foundation Inc. Rochester, New York  14623
Carolina Cancer Management, Inc. Fayetteville, North Carolina  28304
Hematology & Oncology Associates of Northeastern PA Dunmore, Pennsylvania  18512
Greater Philadelphia Cancer Philadelphia, Pennsylvania  19114
Univeristy of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15232
Pottsville Cancer Care Pottsville, Pennsylvania  17901
Charleston Hematology Oncology PA Charleston, South Carolina  29403
Cancer Centers of the Carolina Greenville, South Carolina  29615
Chattanooga Oncology & Hematology Assoc. Chattanooga, Tennessee  TN
Texas Cancer Center-Abilene Abilene, Texas  79606-5208
Urology Associates of North Texas (UANT) Arlington, Texas  76017
MamieMcFaddin Ward Cancer Center Beaumont, Texas  77702-1449
Texas Cancer Center ar Medical City Dallas, Texas  75230-2510
El Paso Cancer Treatment Center-East El Paso, Texas  79915
The Center for Cancer & Blood Disorders Fort Worth, Texas  76104
Southwest Cancer Treatment and Research Center Lubbock, Texas  79415
Cancer Care Network of South Texas, HOAST New Braunfels, Texas  78131
InVisions Consultants LLC San Antonio, Texas  78233
South Texas Oncology and Hematology, PA San Antonio, Texas  78229
Texas Cancer Center- Sherman Sherman, Texas  75090-0504
Texas Oncology Cancer Care and Research Center Waco, Texas  76712