Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-resistant Prostate Cancer | NCT00744497 | Trialant

Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-resistant Prostate Cancer | NCT00744497 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

History of histologically diagnosed prostate cancer

Evidence of metastatic disease by any 1 of the following: computed tomography scan, magnetic resonance imaging, bone scan, or skeletal survey

Evidence of progression, as defined by 1 of the following: rising prostate specific antigen levels at least 1 week apart with the final value being >=2 ng/mL; progression of measurable nodal or visceral disease, with nodal lesions >=20 mm and visceral lesions measurable per response evaluation criteria for solid tumors (Response Evaluation in Solid Tumors, version 1); 2 or more lesions appearing on bone scan compared with previous scan; or local recurrence in the prostate or prostate bed

Maintaining castrate status: Participants who have not undergone surgical orchiectomy should have received and continue on medical therapies, such as gonadotropin releasing hormone analogs, to maintain castrate levels of serum testosterone <=50 ng/dL

Eastern Cooperative Oncology Group Performance Status of 0 to 2

At least 4 weeks since an investigational agent prior to starting study therapy

At least 8 weeks since radioisotope therapy prior to starting study therapy

Recovery from any local therapy including surgery or radiation/radiotherapy for a minimum of 7 days prior to starting study therapy

Required initial laboratory values: white blood cell count >=3,000/mm^3; absolute neutrophil count >=1,500/mm^3; platelet count >=100,000/mm^3; creatinine level <=1.5*upper limit of normal (ULN); bilirubin <=ULN; aspartate aminotransferase <=2.5*ULN; alanine aminotransferase <=2.5*ULN.

Exclusion Criteria:

Symptomatic brain metastases or leptomeningeal metastases

Clinically significant cardiovascular disease, including myocardial infarction; ventricular tachyarrhythmia within 6 months; prolonged QTc >450 msec; ejection fraction <40%; or major conduction abnormality, unless a cardiac pacemaker is present

Pleural or pericardial effusion of any Common Terminology Criteria (CTC) grade

Peripheral neuropathy CTC Grade >=2

Currently active second malignancy other than nonmelanoma skin cancers. Participants are not considered to have a currently active malignancy if they have completed therapy and are now considered (by their physician) to be at less than 30% risk for relapse

Uncontrolled intercurrent illness including ongoing or active infection, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

HIV infection-positive patients receiving combination antiretroviral therapy

History of allergic reactions attributed to compounds of similar chemical or biologic composition to the investigational agents

Receipt of any other investigational agents for the treatment of prostate cancer

Prior cytotoxic chemotherapy in the metastatic setting, with the exception of estramustine

Patients may continue on a daily multivitamin but must discontinue all other herbal, alternative, and food supplements before enrollment

Ketoconazole must be discontinued 4 weeks prior to starting study therapy

Antiandrogens must be discontinued prior to starting study therapy. Patients with a history of response to an antiandrogen and subsequent progression while on that antiandrogen should be assessed for antiandrogen withdrawal response for 4 weeks. Observation for antiandrogen withdrawal response is not necessary for those who have never responded to antiandrogens

Bisphosphonates must not be initiated within 28 days prior to starting study therapy

QT prolonging agents strongly associated with torsade de pointes.

University Of South Alabama / Mitchell Cancer Institute

Mobile, Alabama 36604, United States

Southern Cancer Center

Mobile, Alabama 36608, United States

Alaska Clinical Research Center, Llc

Anchorage, Alaska 99508, United States

Highlands Oncology Group

Fayetteville, Arkansas 72703, United States

Compassionate Cancer Care Medical Group, Inc.

Corona, California 92879, United States

Desert Hematology Oncology Medical Group

Rancho Mirage, California 92270, United States

Compassionate Cancer Care Medical Group Inc

Riverside, California 92501, United States

Sharp Clinical Oncology Research

San Diego, California 92123, United States

Va San Diego Healthcare System

San Diego, California 92161, United States

Edward Alexson, Md, Inc.

Santa Ana, California 92705, United States

Connecticut Oncology Group

Middletown, Connecticut 06457, United States

Va Connecticut Healthcare System

West Haven, Connecticut 06516, United States

Gwinnett Hospital System Inc.

Lawrenceville, Georgia 30046, United States

University Of Chicago

Chicago, Illinois 60637, United States

Midwestern Regional Medical Center

Zion, Illinois 60099, United States

Fort Wayne Medical Oncology And Hematology Inc

Fort Wayne, Indiana 46845, United States

Cancer Center Of Kansas

Wichita, Kansas 67214, United States

Maine Center For Cancer Medicine

Scarborough, Maine 04074, United States

Tufts Medical Center

Boston, Massachusetts 02111, United States

Jackson Oncology Associates, Pllc

Jackson, Mississippi 39202, United States

North Mississippi Hematology And Oncology Associates, Ltd

Tupelo, Mississippi 38801, United States

New York Oncology Hematology, Pc

Albany, New York 12206, United States

New York Oncology Hematology, Pc

Albany, New York 12208, United States

Samuel S. Stratton Vamc

Albany, New York 12208, United States

Roswell Park Cancer Institute

Buffalo, New York 14263, United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065, United States

Duke University Medical Center

Durham, North Carolina 27710, United States

Piedmont Hematology Oncology Associates, Pllc

Winston-Salem, North Carolina 27103, United States

Summa Health System

Akron, Ohio 44304, United States

Mid Ohio Oncology/Hematology, Inc,Dba

Columbus, Ohio 43219, United States

Providence Portland Med Ctr

Portland, Oregon 97213, United States

Regional Hemetology Oncology, Pc

Langhorne, Pennsylvania 19047, United States

Upmc Cancer Pavilion

Pittsburgh, Pennsylvania 15232, United States

Va Pittsburgh Healthcare System

Pittsburgh, Pennsylvania 15240, United States

Associates In Hematology & Oncology, P.C.

Upland, Pennsylvania 19013, United States

The Miriam Hospital

Providence, Rhode Island 02906, United States

Cancer Centers Of The Carolinas

Greenville, South Carolina 29615, United States

Boston Baskin Cancer Foundation

Memphis, Tennessee 38120, United States

Cancer Specialists Of South Texas, Pa

Corpus Christi, Texas 78412, United States

The University Of Texas Md Anderson Cancer Center

Houston, Texas 77030, United States

Providence Regional Cancer System

Lacey, Washington 98503, United States

University Of Washington

Seattle, Washington 98109, United States

Dean Hematology And Oncology Clinic

Madison, Wisconsin 53717, United States

Local Institution

Buenos Aires, Buenos Aires C1181ACH, Argentina

Local Institution

Buenos Aires, Buenos Aires C1280AEB, Argentina

Local Institution

Buenos Aires, Buenos Aires C1426ANZ, Argentina

Local Institution

Caba, Buenos Aires 1417, Argentina

Local Institution

Capital Federal, Buenos Aires 1425, Argentina

Local Institution

Capital Federal, Buenos Aires 1426, Argentina

Local Institution

Capital Federal, Buenos Aires C1405BCJ, Argentina

Local Institution

La Plata, Buenos Aires 1900, Argentina

Local Institution

Ramos Mejía, Buenos Aires 1234, Argentina

Local Institution

Cipolletti, Río Negro Province R8324BEH, Argentina

Local Institution

Rosario, Santa Fe Province S2000CVD, Argentina

Local Institution

Rosario, Santa Fe Province S2000DSK, Argentina

Local Institution

San Miguel de Tucumán, Tucumán Province T4000IAK, Argentina

Local Institution

Cordaba, 5000, Argentina

Local Institution

Coffs Harbour, New South Wales 2450, Australia

Local Institution

Lismore, New South Wales 2480, Australia

Local Institution

Port Macquarie, New South Wales 2444, Australia

Local Institution

Sydney, New South Wales 2076, Australia

Local Institution

Douglas, Queensland 4814, Australia

Local Institution

Milton, Queensland 4164, Australia

Local Institution

Kurralta Park, South Australia 5037, Australia

Local Institution

Hobart, Tasmania 7000, Australia

Local Institution

Frankston, Victoria 3199, Australia

Local Institution

Ringwood, Victoria 3135, Australia

Local Institution

Fremantle, Western Australia 6162, Australia

Local Institution

Salvador, Estado de Bahia 41950, Brazil

Local Institution

Rio de Janeiro, Rio de Janeiro 20230, Brazil

Local Institution

Rio de Janeiro, Rio de Janeiro 22551, Brazil

Local Institution

Porto Alegre, Rio Grande do Sul 90610, Brazil

Local Institution

Barretos, São Paulo 14784, Brazil

Local Institution

Campinas, São Paulo 13083, Brazil

Local Institution

Jaú, São Paulo 17210, Brazil

Local Institution

Santo André, São Paulo 09060, Brazil

Local Institution

Edmonton, Alberta T6G 1Z2, Canada

Local Institution

Abbottsford, British Columbia V2S 3N5, Canada

Local Institution

Moncton, New Brunswick E1C 6Z8, Canada

Local Institution

Greater Sudbury, Ontario P3E 5J1, Canada

Local Institution

Ottawa, Ontario K1H 8L6, Canada

Local Institution

Owen Sound, Ontario N4K 2J1, Canada

Local Institution

Thunder Bay, Ontario P7B 6V4, Canada

Local Institution

Greenfield Park, Quebec J4V 2H1, Canada

Local Institution

Montreal, Quebec H2W 1S6, Canada

Local Institution

Montreal, Quebec H2W 1Y5, Canada

Local Institution

Rimouski, Quebec G5L 5T1, Canada

Local Institution

Sherbrooke, Quebec J1H 5N4, Canada

Local Institution

Regina, Saskatchewan S4T 7T1, Canada

Local Institution

Saskatoon, Saskatchewan S7N 4H4, Canada

Local Institution

Brno, 656 53, Czechia

Local Institution

Hradec Králové, 500 05, Czechia

Local Institution

Prague, 128 08, Czechia

Local Institution

Prague, 180 81, Czechia

Local Institution

Turku, 20520, Finland

Local Institution

Vaasa, 65130, Finland

Local Institution

Avignon, 84082, France

Local Institution

Besançon, 25030, France

Local Institution

Caen, 14076, France

Local Institution

Créteil, 94010, France

Local Institution

Paris, 75908, France

Local Institution

Saint-Genis-Laval, 69230, France

Local Institution

Strasbourg, 67085, France

Local Institution

Aachen, 52074, Germany

Local Institution

Berlin, 12200, Germany

Local Institution

Erlangen, 91054, Germany

Local Institution

Essen, 45122, Germany

Local Institution

Kirchheim, 73230, Germany

Local Institution

Markkleeberg, 04416, Germany

Local Institution

Athens, 11528, Greece

Local Institution

Budapest, 1122, Hungary

Local Institution

Kecskemét, 6000, Hungary

Local Institution

Zalaegerszeg, 8900, Hungary

Local Institution

Trivandrum, Kerala 695011, India

Local Institution

Mumbai, Maharashtra 400026, India

Local Institution

Pune, Maharashtra 411001, India

Local Institution

Pune, Maharashtra 411004, India

Local Institution

Ahmedabad, 380009, India

Local Institution

Jaipur, 302013, India

Local Institution

Kolkata, 700 016, India

Local Institution

Kolkata, 700 053, India

Local Institution

Cork, Cork, Ireland

Local Institution

Dublin, Dublin 7, Ireland

Local Institution

Dublin, Dublin, Ireland

Local Institution

Tallaght, Dublin DUBLIN 24, Ireland

Local Institution

Arezzo, 52100, Italy

Local Institution

Genova, 16132, Italy

Local Institution

Lecce, 73100, Italy

Local Institution

Milan, 20141, Italy

Local Institution

Naples, 80131, Italy

Local Institution

Perugia, 06132, Italy

Local Institution

Roma, 00161, Italy

Local Institution

Tijuana, Estado de Baja California 22010, Mexico

Local Institution

Guadalajara, Jalisco 44280, Mexico

Local Institution

Zapopan, Jalisco 45150, Mexico

Local Institution

Df, Mexico City 06720, Mexico

Local Institution

Mexico City, Mexico City 14050, Mexico

Local Institution

Tlalpan, Mexico City 14000, Mexico

Local Institution

Tlalpan, Mexico City 14080, Mexico

Local Institution

Monterrey, Nuevo León 64460, Mexico

Local Institution

México, Querétaro 76200, Mexico

Local Institution

Huixquilucan, State of Mexico 52763, Mexico

Local Institution

Toluca, State of Mexico 50180, Mexico

Local Institution

Stavanger, 4068, Norway

Local Institution

Lima, Lima Province 11, Peru

Local Institution

Lima, Lima Province 34, Peru

Local Institution

Lima, Lima Province 41, Peru

Local Institution

Lima, Lima Province LIMA 11, Peru

Local Institution

Lima, Lima Province LIMA 29, Peru

Local Institution

Callao, Provincia Constitucional del Callao CALLAO 2, Peru

Local Institution

Bialystok, 15-027, Poland

Local Institution

Lodz, 93-509, Poland

Local Institution

Warsaw, 02-781, Poland

Local Institution

Baia Mare, 430031, Romania

Local Institution

Cluj-Napoca, 400015, Romania

Local Institution

Timisoara, Timis, 300239, Romania

Local Institution

Moscow, 115478, Russia

Local Institution

Moscow, 117997, Russia

Local Institution

Saint Petersburg, 197022, Russia

Local Institution

Saint Petersburg, 197758, Russia

Local Institution

Bloemfontein, Free State 9301, South Africa

Local Institution

Pretoria, Gauteng 0181, South Africa

Local Institution

Saxonwold, Gauteng 2199, South Africa

Local Institution

Seoul, 120-752, South Korea

Local Institution

Seoul, 135-710, South Korea

Local Institution

Seoul, 135-720, South Korea

Local Institution

Seoul, 138-736, South Korea

Local Institution

Barcelona, 08003, Spain

Local Institution

Barcelona, 08025, Spain

Local Institution

Barcelona, 08208, Spain

Local Institution

Gijón, 33394, Spain

Local Institution

Madrid, 28007, Spain

Local Institution

Madrid, 28033, Spain

Local Institution

Madrid, 28050, Spain

Local Institution

Santander, 39008, Spain

Local Institution

Seville, 41013, Spain

Local Institution

Valencia, 46009, Spain

Local Institution

Kungälv, 442 83, Sweden

Local Institution

Sundsvall, 851 86, Sweden

Local Institution

Uppsala, 751 85, Sweden

Local Institution

Vaxjo, 351 85, Sweden

Local Institution

Essex, Essex CO3 3NB, United Kingdom

Local Institution

Cardiff, Glamorgan CF14 2TL, United Kingdom

Local Institution

London, Middlesex W12 0NN, United Kingdom

Local Institution

Sutton, Surrey SM2 5PT, United Kingdom

Local Institution

Leeds, West Yorkshire LS8 7TF, United Kingdom