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NCT00056446

Estudio de oxaliplatino/5-FU/leucovorina más vatalanib frente a oxaliplatino/5-FU/leucovorina en pacientes con cáncer colorrectal metastásico previamente tratado.

Archived Fase 3

Descripción

El objetivo de este estudio es comparar el tratamiento con oxaliplatino/5-FU/leucovorina más vatalanib frente a oxaliplatino/5-FU/leucovorina más placebo en pacientes con cáncer colorrectal que se ha extendido a otros órganos y cuya enfermedad ha empeorado tras el tratamiento con irinotecán.

Evidencia de la diana molecular en cáncer colorrectal

Aún no hay evidencia documentada en nuestra base para la diana o el fármaco de este ensayo. Esta sección crece a medida que se procesan nuevas publicaciones.

Criterios de Elegibilidad

Criterios de inclusión

  • Adenocarcinoma confirmado de colon o recto en pacientes con enfermedad metastásica
  • Un régimen de quimioterapia previo con irinotecán y 5FU
  • Evidencia de enfermedad progresiva dentro de los 6 meses posteriores a la última dosis de irinotecán
  • Estado funcional de la OMS de 0, 1 o 2
  • Tumores medibles
  • Estado hematológico, hepático y renal adecuado
  • Esperanza de vida mayor de 12 semanas
  • Consentimiento informado por escrito obtenido

Criterios de exclusión

  • Antecedentes o presencia de enfermedad del sistema nervioso central
  • Pacientes con antecedentes de otro cáncer primario en los últimos 5 años
  • Quimioterapia previa dentro de las 3 semanas anteriores a la inclusión en el estudio
  • Cirugía mayor dentro de las 4 semanas o cirugía menor dentro de las 2 semanas anteriores a la inclusión en el estudio
  • Fármacos experimentales dentro de las 4 semanas anteriores a la inclusión en el estudio
  • Terapia previa con oxaliplatino
  • Neuropatía periférica con deterioro funcional
  • Pacientes mujeres que estén embarazadas o en período de lactancia
  • Cualquier condición médica grave o no controlada que pueda impedir la participación en el estudio
  • Enfermedad renal crónica
  • Enfermedad hepática aguda o crónica
  • Pacientes que estén tomando Coumadin

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Información del Ensayo

NCT00056446
Archived
Fase 3
855 participantes
Ene 2003

Ubicaciones251

Australia (2)
Novartis Investigative Site
Frankston, VIC
Novartis Investigative Site
Woodville South, SA
Austria (1)
Novartis Investigative Site
Sankt Veit an der Glan, 9300
Belgium (6)
Novartis Investigative Site
Antwerp, 2020
Novartis Investigative Site
Brasschaat, 2930
Novartis Investigative Site
Brussels, 1200
Novartis Investigative Site
Leuven
Novartis Investigative Site
Liège, 4000
Novartis Investigative Site
Wilrijk, 2610
Brazil (6)
Novartis Investigative Site
Porto Alegre RS, CEP 90 610-000
Novartis Investigative Site
Salvador - Ba, 41825-010
Novartis Investigative Site
Salvador, Bahia, CEP 40170-070
Novartis Investigative Site
São Paulo, 01236-000
Novartis Investigative Site
São Paulo, 01308-050
Novartis Investigative Site
São Paulo, 01406-100
Canada (21)
Novartis Investigative Site
Calgary, Alberta, T2N4N2
Novartis Investigative Site
Penticton, British Columbia, V2A3G6
Novartis Investigative Site
Winnepeg, Manitoba, R2H 2A6
Novartis Investigative Site
Sydney, Nova Scotia, B1P 1P3
Novartis Investigative Site
Barrie, Ontario, L4M6M2
Novartis Investigative Site
Brampton, Ontario, L6W 2Z8
Novartis Investigative Site
Greater Sudbury, Ontario, P3E 5J1
Novartis Investigative Site
Hamilton, Ontario, L8V 5C2
Novartis Investigative Site
Ottawa, Ontario, K1H 1C4
Novartis Investigative Site
Sainte-Foy, Ontario, G1V 4G5
Novartis Investigative Site
St. Catharines, Ontario, L2R5K3
Novartis Investigative Site
Thunder Bay, Ontario, P7A 7T1
Toronto, Ontario, M4C 3E7
Novartis Investigative Site
Toronto, Ontario, M4N3M5
Novartis Investigative Site
Toronto, Ontario, M5G1X5
Novartis Investigative Site
Toronto, Ontario
Novartis Investigative Site
Windsor, Ontario, N8W 2X3
Novartis Investigative Site
Greenfield Park, Quebec, J4V2H1
Novartis Investigative Site
Montreal, Quebec, H2L 4M1
Novartis Investigative Site
Montreal, Quebec, H2W 1S6
Novartis Investigative Site
Saskatoon, Saskatchewan, S7N4H4
France (10)
Novartis Investigative Site
Avignon, 84000
Novartis Investigative Site
Boulogne, 92104
Novartis Investigative Site
Lille, 59020
Novartis Investigative Site
Marseille, 13385
Novartis Investigative Site
Montpellier, 34298
Novartis Investigative Site
Nice, 6189
Novartis Investigative Site
Rennes, 35042
Novartis Investigative Site
Saint-Herblain, 44805
Novartis Investigative Site
Strasbourg, 67000
Novartis Investigative Site
Toulouse, 31052
Germany (19)
Novartis Investigative Site
Augsburg, 86150
Novartis Investigative Site
Berlin, 13585
Novartis Investigative Site
Berlin, 14195
Novartis Investigative Site
Bielefeld, 33604
Novartis Investigative Site
Braunschweig, 38100
Novartis Investigative Site
Cologne, 50677
Novartis Investigative Site
Dessau, 6822
Novartis Investigative Site
Dresden, 1307
Novartis Investigative Site
Essen, 45122
Novartis Investigative Site
Essen, 45136
Novartis Investigative Site
Frankfurt, 60488
Novartis Investigative Site
Hamburg, 22087
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Magdeburg, 39002
Novartis Investigative Site
München, 81675
Novartis Investigative Site
Neumünster, 24534
Novartis Investigative Site
Trier, 54290
Novartis Investigative Site
Ulm, 89081
Novartis Investigative Site
Wiesbaden, 65199
Hong Kong (1)
Novartis Investigative Site
Chai Wan
Italy (12)
Novartis Investigative Site
Ancona, 60020
Novartis Investigative Site
Bergamo, 24128
Novartis Investigative Site
Brescia, 25124
Novartis Investigative Site
Cremona, 26100
Novartis Investigative Site
Genova, 16132
Novartis Investigative Site
Livorno, 57100
Novartis Investigative Site
Milan, 20100
Novartis Investigative Site
Milan, 20141
Novartis Investigative Site
Reggio Emilia, 42100
Novartis Investigative Site
Roma, 135
Novartis Investigative Site
Roma, 149
Novartis Investigative Site
Rozzano, 20089
New Zealand (3)
Novartis Investigative Site
Auckland
Novartis Investigative Site
Christchurch
Novartis Investigative Site
Wellington
Portugal (2)
Novartis Investigative Site
Coimbra, 3000-076
Novartis Investigative Site
Lisbon, 1649-035
Slovakia (1)
Novartis Investigative Site
Bratislava, 81250
Spain (8)
Novartis Investigative Site
Córdoba, 14004
Novartis Investigative Site
Elche, 3202
Novartis Investigative Site
Madrid, 28007
Novartis Investigative Site
Madrid, 28033
Novartis Investigative Site
Madrid, 28040
Novartis Investigative Site
Madrid, 8907
Novartis Investigative Site
Málaga, 29010
Novartis Investigative Site
Zaragoza, 5009
Sweden (2)
Novartis Investigative Site
Gothenburg, SE-416 85
Novartis Investigative Site
Stockholm, SE-118 83
Switzerland (2)
Novartis Investigative Site
Bern, 3010
Novartis Investigative Site
Thun, 3600
Taiwan (7)
Novartis Investigative Site
Changhua
Novartis Investigative Site
Kaohsiung City
Novartis Investigative Site
Keelung
Novartis Investigative Site
Taichung
Novartis Investigative Site
Tainan
Novartis Investigative Site
Taipei
Novartis Investigative Site
Taoyuan District
United Kingdom (5)
Novartis Investigative Site
Belfast, BT9 7AB
Novartis Investigative Site
Birmingham, B15 2TH
Novartis Investigative Site
Cardiff, CF147TB
Novartis Investigative Site
London, W1T 3AA
Novartis Investigative Site
Manchester, M20 4BX
United States (143)
Comprehensive Cancer Institute
Huntsville, Alabama, 35801
Alaska Oncology and Hematology
Anchorage, Alaska, 99508
Arizona Clinical Research Center
Tucson, Arizona, 85712
Northeast Arkansas Clinic
Jonesboro, Arkansas, 72401
Arkansas Cancer Research Center
Little Rock, Arkansas, 72205
Little Rock Hematology & Oncology
Little Rock, Arkansas, 72205
Highlands Oncology Group
Springdale, Arkansas, 72764
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
Providence St. Joseph Medical Center
Burbank, California, 91505
Compassionate Cancer Care Medical Group, Inc.
Fountain Valley, California, 92708
California Oncology of the Central Valley
Fresno, California, 93710
Virginia K. Crosson Cancer Center
Fullerton, California, 92835
Glendale Adventist Medical Center
Glendale, California, 91206
Scripps Green Hospital
La Jolla, California, 92037
Wilshire Oncology Medical Group
La Verne, California, 91767
Pacific Shores Medical Group
Long Beach, California, 90813
Novartis Investigative Site
Los Angeles, California, 90095
Synergy Hematology-Oncology Medical Associates
Los Angeles, California, 90036
UCLA School of Medicine
Los Angeles, California, 90095
USC Norris Cancer Center
Los Angeles, California, 90033
Eddie Hong-Lung Hu, M.D.
Monterey Park, California, 91754
North Valley Hematology/Oncology Medical Group
Northridge, California, 91328
Medical Oncology Care Associates
Orange, California, 92868
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030
Sierra View District Hospital
Porterville, California, 93257
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, 90277
Santa Clara Valley Medical Center
San Jose, California, 95128
Sansum Santa Barbara Foundation Medical Clinic
Santa Barbara, California, 93105
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, 93105
San Diego Cancer Center Medical Group
Vista, California, 92083
Mile High Oncology
Denver, Colorado, 80210
Rocky Mountain Cancer Center
Denver, Colorado, 80220
Manchester Hematology/Oncology Assoc.
Manchester, Connecticut, 06040
Washington Oncology/Hematology Center
Washington D.C., District of Columbia, 20037
The Center for Hematology and Oncology
Boca Raton, Florida, 33486
Florida Cancer Specialists
Fort Myers, Florida, 33901
Hematology Oncology Associates
Lake Worth, Florida, 33461-4710
Oncology/Hematology Group of South Florida
Miami, Florida, 33176
University of Miami School of Medicine
Miami, Florida, 33136
Hematology Oncology Associates of Treasure Coast
Port Saint Lucie, Florida, 34952
Florida Medical Clinic
Zephyrhills, Florida, 33542
Atlanta Cancer Care
Marietta, Georgia, 30060
Coastal Hematology & Oncology
Savannah, Georgia, 31406
Office of Research
Savannah, Georgia, 31405
Lewis Hall Singletary Oncology Center
Thomasville, Georgia, 31792
North Idaho Cancer Center
Coeur d'Alene, Idaho, 83814
University of Chicago medical Center, Hematology/Oncology
Chicago, Illinois, 60637
Oncology Hematology Associates of Central Illinois, PC
Peoria, Illinois, 61602
Midwest Cancer Research Group
Skokie, Illinois, 60077
Northshore Cancer Research Association
Skokie, Illinois, 60076
Fort Wayne Medical Oncology & Hematology, Inc.
Fort Wayne, Indiana, 46815
Munster Community Hospital
Munster, Indiana, 46321
Cotton O'Neil Oncology Clinic
Topeka, Kansas, 66606
Vijay Raghaven, M.D.
Louisville, Kentucky, 40215
Owensboro Medical Health System
Owensboro, Kentucky, 42303
Cabrini Center for Cancer Care
Alexandria, Louisiana, 71301
LSU Medical Center
New Orleans, Louisiana, 70112
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
LSU Health Sciences Center
Shreveport, Louisiana, 71130-3932
Maine Center for Cancer Medicine & Blood Disorders
Scarborough, Maine, 04074
Franklin Square Hospital Center
Baltimore, Maryland, 21237
St. Agnes Healthcare
Baltimore, Maryland, 21229-5299
Kaiser Permanente
Rockville, Maryland, 20850
Fallon Clinic at Worcester Medical Center
Worcester, Massachusetts, 01605
University of Michigan
Ann Arbor, Michigan, 48109-0934
Spectrum Health -- Cook Research Dept.
Grand Rapids, Michigan, 49503
Oncology Care Associates, PLLC
Saint Joseph, Michigan, 49085
Providence Cancer Center
Southfield, Michigan, 48075
Minnesota CGOP
Minneapolis, Minnesota, 55407
Heartland Hematology
Kansas City, Missouri, 64118
Missouri Cancer Care, PC
Saint Charles, Missouri, 63301
Arch Medical Services Incorporated
St Louis, Missouri, 63141
Missouri Baptist Cancer Center
St Louis, Missouri, 63131
Saint Louis University
St Louis, Missouri, 63110
Washington University School of Medicine
St Louis, Missouri, 63110
North Central Montana Professional Building
Great Falls, Montana, 59405
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89109
Nevada Cancer Center
Las Vegas, Nevada, 89109
NH Oncology-Hematology, PA
Hooksett, New Hampshire, 03106
Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, 08003
St. Barnabas Cancer Center
Livingston, New Jersey, 07039
Hematology Oncology Associates of Northern New Jersey
Morristown, New Jersey, 07960
Cooper Cancer Center
Voorhees Township, New Jersey, 08043
Hematology/Oncology Associates
Albuquerque, New Mexico, 87102
New Mexico Oncology/Hematology
Albuquerque, New Mexico, 87109
Roswell Park Cancer Institute
Buffalo, New York, 14263
Hematology/Oncology Associates of Central NY
East Syracuse, New York, 13057
Queens Medical Associates, PC
Fresh Meadows, New York, 11365
Charles R. Wood Cancer Center
Glens Falls, New York, 12801
North Shore University Hospital
Manhasset, New York, 11030
St. Vincent's Catholic Medical Centers of New York
New York, New York, 10011
Hematology-Oncology Associates of Rockland
Nyack, New York, 10956
James P. Wilmot Cancer Center
Rochester, New York, 14642
Pluta Cancer Center
Rochester, New York, 14623
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599-7305
Carolinas Hematology/Oncology Associates
Charlotte, North Carolina, 28203
Nashat Gabrail, M.D.
Canton, Ohio, 44718
Case Western Reserve University
Cleveland, Ohio, 44106-5056
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Columbus CCOP
Columbus, Ohio, 43206
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Oklahoma Oncology, Inc.
Tulsa, Oklahoma, 74104
Consultants in Medical Oncology & Hematology
Drexel Hill, Pennsylvania, 19026
Hematology & Oncology Associates of NE PA
Dunmore, Pennsylvania, 18512
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Monongahela Valley Hospital
Monongahela, Pennsylvania, 15063
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772
UPMC Cancer Pavillion
Pittsburgh, Pennsylvania, 15232
Charleston Cancer Center
Charleston, South Carolina, 29406
South Carolina Oncology Associates
Columbia, South Carolina, 29201
WJB Dom VAMC
Columbia, South Carolina, 29209
Cancer Center of the Carolinas
Greenville, South Carolina, 29615
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
Erlanger Health System
Chattanooga, Tennessee, 37403
Clarksville Regional Hematology/Oncology
Clarksville, Tennessee, 37043
The Jones Clinic
Germantown, Tennessee, 38138
Baptist Regional Cancer Center
Knoxville, Tennessee, 37920
University of Tennessee Cancer Institute
Memphis, Tennessee, 38104
Meharry Medical College
Nashville, Tennessee, 37208
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
Vanderbilt University School of Medicine
Nashville, Tennessee, 37232-6307
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37212
Harrington Cancer Center
Amarillo, Texas, 79106
Center for Oncology Research & Treatment
Dallas, Texas, 75230
Clinical Hematology & Oncology
Dallas, Texas, 75235
H. Alejandro Preti, M.D., PA
Houston, Texas, 77030
M.D. Anderson Cancer Center
Houston, Texas, 77030
Oncology Consultants
Houston, Texas, 77024
South Texas Oncology & Hematology
San Antonio, Texas, 78207
Scott & White Hospital
Temple, Texas, 76508
Northern Utah Cancer Associates
Ogden, Utah, 84403
Southwestern Vermont Health Care
Bennington, Vermont, 05201
Virginia Oncology Associates
Norfolk, Virginia, 23502
Cancer Treatment Centers of America in Hampton Roads
Portsmouth, Virginia, 23704
Western Washington Clinic
Everett, Washington, 98201
Cascade Cancer Center
Kirkland, Washington, 98034
Rainier Oncology
Puyallup, Washington, 98372
Swedish Cancer Institute
Seattle, Washington, 98104
Virginia Mason Medical Center
Seattle, Washington, 98101
West Virginia University Health Sciences Center
Morgantown, West Virginia, 26506
Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188
Kettle Morain Oncology
West Bend, Wisconsin, 53095

Fuente Oficial

Ver en ClinicalTrials.gov