Know Cancer

or
forgot password

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 CarolinaCharleston, South Carolina  29425-0721
Medical College of WisconsinMilwaukee, Wisconsin  53226
Stanford UniversityStanford, California  94305
South Georgia Medical CenterValdosta, Georgia  31603
Texas Oncology, P.A.Dallas, Texas  75246
University of Kansas Medical CenterKansas City, Kansas  66160-7353
University of Rochester Medical CenterRochester, New York  14642
Sutter Cancer CenterSacramento, California  95816
Dakota Cancer InstituteFargo, North Dakota  58103-4940
SUNY Downstate Medical CenterBrooklyn, New York  11203
Virginia Oncology AssociatesNewport News, Virginia  23606
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Siouxland Hematology-Oncology AssociatesSioux City, Iowa  51101
Ocala Oncology CenterOcala, Florida  34474
Florida Cancer SpecialistsFort Myers, Florida  33901
Missouri Cancer AssociatesColumbia, Missouri  65201
University of OklahomaOklahoma City, Oklahoma  73190
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Pacific Shores Medical GroupLong Beach, California  90813
Rocky Mountain Cancer CentersThornton, Colorado  80260
Sharp Memorial HospitalSan Diego, California  92123
Sutter Gould Medical FoundationModesto, California  95353
New Mexico Cancer Care AssociatesSanta Fe, New Mexico  87505-7670
University of WashingtonSeattle, Washington  98195
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
Atlanta Cancer CareAtlanta, Georgia  30342
Genesis Cancer CenterHot Springs, Arkansas  71913
Hope CenterTerre Haute, Indiana  47809
Cancer Care AssociatesTulsa, Oklahoma  74136
Willamette Valley Cancer CenterEugene, Oregon  97401-8122
Tower Cancer Research FoundationBeverly Hills, California  90211
St. Joseph Oncology, Inc.Saint Joseph, Missouri  64506
Henry Ford Health SystemDetroit, Michigan  48202
Georgia Cancer SpecialistMarietta, Georgia  30060
Monterey Bay OncologyMonterey, California  93940
Charleston Cancer CenterCharleston, South Carolina  29406
Broward Oncology AssociatesFt. Lauderdale, Florida  33308
California Pacific Medical CenterSan Francisco, California  94115
Oncology Hematology Care, Inc.Cincinnati, Ohio  45219
Northeast Georgia Cancer Care, LLCAthens, Georgia  30607
The Cleveland Clinic FoundationCleveland, Ohio  
Hematology Oncology Associates of IllinoisSkokie, Illinois  60077
Cancer Centers of Florida, P.A.Orlando, Florida  
Texas OncologyDallas, Texas  
Innovative Medical Research of South Florida Inc.Miami Shores, Florida  33138
Gabrail Cancer CenterCanton, Ohio  44718
Maine Center for Cancer Medicine & Blood DisordersScarborough, Maine  04074
Medical Center of VincennesVincennes, Indiana  47591
Texas Oncology, PADallas, Texas  75246-2006
Florida Cancer InstituteNew Port Richey, Florida  34652
Central Indiana Cancer CentersIndianapolis, Indiana  46227
Minnesota Oncology Hematology, P.A.Minneapolis, Minnesota  55407
Overlook Oncology CenterSummit, New Jersey  07901
Medical Oncology Associates of Wyoming Valley, PCKingston, Pennsylvania  18704
Allison Cancer CenterMidland, Texas  79701
West Texas Cancer CenterOdessa, Texas  79761
Southern Arizona VA Healthcare SystemTucson, Arizona  85723
Frederick Memorial HospitalFrederick, Maryland  21701
Highline Medical OncologyBurien, Washington  98166
Consultants in Medical Oncology & HematologyDrexel Hill, Pennsylvania  19026
The Jones ClinicGermantown, Tennessee  38138
Mid Ohio Oncology/Hematology, Inc.Columbus, Ohio  43213
Horizon's West Medical GroupScottsbluff, Nebraska  69361
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Alaska Clinical Research CenterAnchorage, Alaska  99508
Staten Island Urological Research, PCStaten Island, New York  10304
Nevada Cancer InstituteLas Vegas, Nevada  89135
Midwest Prostate & Urology Health CenterChicago, Illinois  60640
Piedmont Hematology Oncology Associates, PLLCWinston-Salem, North Carolina  
Northwest Cancer Specialists, P.C.Vancouver, Washington  
Texas Cancer CenterAbilene, Texas  79606
Texas Oncology Cancer CenterAustin, Texas  78731
The Texas Cancer CenterDallas, Texas  75237
Lake Vista Cancer CenterLewisville, Texas  75067
Texas Cancer Center of MesquiteMesquite, Texas  75150
North Broward Medical CenterDearfield Beach, Florida  33064-3596
Raleigh Hematology Oncology AssociatesCary, North Carolina  27511
Guthrie ClinicSayre, Pennsylvania  18840
Center for Oncology Research and Treatment, PADallas, Texas  75230
Oncology SpecialistsPark Ridge, Illinois  60068
Puget Sound Cancer CentersEdmonds, Washington  98026
Maryland Oncology Hematology, P.A.Columbia, Maryland  21044
Dayton Oncology & Hematology, P.A.Kettering, Ohio  45409
South Texas Cancer Center - McAllenMcAllen, Texas  78503-1298
Paris Regional Cancer CenterParis, Texas  75460
Fairfax Northern Virginia Hematology Oncology, PCFairfax, Virginia  22031
Oncology & Hematology Associates of Southwest Virginia, Inc.Salem, Virginia  24153
Hematology Oncology Life CenterAlexandria, Louisiana  71301
Medical Consultants, PC c/o Ball Cancer CenterMuncie, Indiana  47303
Sarah Cannon Research InstituteNashville, Tennessee  37203
Northwest Alabama Cancer CenterMuscle Shoals, Alabama  35661
Gainesville Hematology Oncology AssociatesGainesville, Florida  32605
St. Mary Medical CenterLanghorne, Pennsylvania  19047
South Carolina Cancer SpecialistsHilton Head Island, South Carolina  29925
Park Nicollet InstituteSt Louis Park, Minnesota  55416
Nebraska Hematology-Oncology, PCLincoln, Nebraska  68506
Phoebe Cancer CenterAlbany, Georgia  31701
Aultman HospitalCanton, Ohio  44710
Cancer Care & Hematology Specialists of ChicagolandNiles, Illinois  60714
Yakima Valley Memorial Hospital/North Star LodgeYakima, Washington  98902
Texas Oncology Cancer Center-Sugar LandSugar Land, Texas  77479
Premiere Oncology of ArizonaScottsdale, Arizona  85260
The Valley HospitalParamus, New Jersey  07652
Birmingham Hematology & Oncology Associates, LLCBirmingham, Alabama  35223
Hematology Associates - AOAPhoenix, Arizona  85012
Northern Arizona Hematology & Oncology Associates, AOASedona, Arizona  86336
U of Arizona / Arizona Cancer CenterTucson, Arizona  85724
The Angeles Clinic and Research Institute, Inc.Los Angeles, California  90025
UCLA department of UrologyLos Angeles, California  90095-1738
Veterans Affairs Northern California Health Care SystemMartinez, California  94553
Comprehensive Cancer Center atPalm Springs, California  92262
UCD Cancer Center-Clinical TrialsSacramento, California  95817
Georgetown University Lombardi Cancer CenterWashington, District of Columbia  20007
Pasco Hernando Oncology Associates, P.A.14529 Cortez Blvd., Florida  34613
Michael and Dianne Bienes Comprehensive Cancer CenterFt. Lauderdale, Florida  33308
Sylvester Comprehensive Cancer Center, U of MiamiMiami, Florida  33136
Pasco Hernando Oncology Associates P.A.New Port Richey, Florida  34652
AYS UrologyTrinity, Florida  34655
Peachtree Hematology-Oncology Consultants, PCAtlanta, Georgia  30309
Northeast GA Medical CenterGainesville, Georgia  30501
Swedish American Regional Cancer CenterRockford, Illinois  61104
Hematology Oncology Associates of Illinois, L.L.CSkokie, Illinois  60077
Iowa Cancer CareCedar Rapids, Iowa  52403
Mercy Medical Center, North IowaMason City, Iowa  50401
St. Agnes Health SystemBaltimore, Maryland  21229
MN Cooperative Group Outreach Prg.Minneapolis, Minnesota  55407
University of Missouri, Ellis Fischel Cancer CenterColumbia, Missouri  65203
Nebraska Methodist Hospital - Oncology Research DeptOmaha, Nebraska  68144
UMDNJ-NewarkNewark, New Jersey  07101
Hematology Oncology Associates ofNew City, New York  10956
Memorial Sloan-KettNew York, New York  10021
Interlakes Foundation Inc.Rochester, New York  14623
Carolina Cancer Management, Inc.Fayetteville, North Carolina  28304
Hematology & Oncology Associates of Northeastern PADunmore, Pennsylvania  18512
Greater Philadelphia CancerPhiladelphia, Pennsylvania  19114
Univeristy of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15232
Pottsville Cancer CarePottsville, Pennsylvania  17901
Charleston Hematology Oncology PACharleston, South Carolina  29403
Cancer Centers of the CarolinaGreenville, South Carolina  29615
Chattanooga Oncology & Hematology Assoc.Chattanooga, Tennessee  TN
Texas Cancer Center-AbileneAbilene, Texas  79606-5208
Urology Associates of North Texas (UANT)Arlington, Texas  76017
MamieMcFaddin Ward Cancer CenterBeaumont, Texas  77702-1449
Texas Cancer Center ar Medical CityDallas, Texas  75230-2510
El Paso Cancer Treatment Center-EastEl Paso, Texas  79915
The Center for Cancer & Blood DisordersFort Worth, Texas  76104
Southwest Cancer Treatment and Research CenterLubbock, Texas  79415
Cancer Care Network of South Texas, HOASTNew Braunfels, Texas  78131
InVisions Consultants LLCSan Antonio, Texas  78233
South Texas Oncology and Hematology, PASan Antonio, Texas  78229
Texas Cancer Center- ShermanSherman, Texas  75090-0504
Texas Oncology Cancer Care and Research CenterWaco, Texas  76712