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NCT00056459
Estudio de oxaliplatino/5-FU/leucovorina más vatalanib frente a oxaliplatino/5-FU/leucovorina en pacientes con cáncer colorrectal metastásico.
Completado
Fase 3
Descripción
Para 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 que están recibiendo su primera quimioterapia.
Evidencia de la diana molecular en cáncer colorrectal
Estos fármacos NO son el fármaco de este ensayo. Es la eficacia publicada de OTROS fármacos que atacan la misma diana molecular, mostrada como contexto — no se refiere a este ensayo concreto ni confirma elegibilidad. Revísalo siempre con tu oncólogo.
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:
- Pacientes con cáncer colorrectal metastásico que acuden para recibir quimioterapia inicial
- Cáncer colorrectal metastásico documentado
- Estado funcional de la OMS de 0, 1 o 2
- Tumores medibles
- Estado hematológico, función hepática y renal adecuados
- 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 para el cáncer colorrectal metastásico
- Radioterapia previa de campo completo en las últimas 4 semanas o radioterapia de campo limitado en las últimas 2 semanas antes de la inclusión en el estudio
- Cirugía mayor en las últimas 4 semanas o cirugía menor en las últimas 2 semanas antes de la inclusión en el estudio
- Fármacos experimentales en las últimas 4 semanas antes de la inclusión en el estudio
- Terapia previa con agentes anti-VEGF
- Cualquier terapia previa con oxaliplatino o alergia a fármacos que contienen platino
- 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
- Pacientes que estén tomando Coumadin
Pueden aplicarse otros criterios de inclusión/exclusión definidos en el protocolo.
Información del Ensayo
NCT00056459
Completado
Fase 3
1168 participantes
Feb 2003
Ubicaciones223
Australia (5)
Adelaide, SA 5000
Garran, ACT 2605
Nedlands, WS 6009
Wollongong, NSW 2500
Woolloongabba, QLD 4102
Belgium (5)
Anderlecht, 1070
Antwerp, 2020
Brussels, 1200
Ghent, 9000
Wilrijk, 2610
Brazil (6)
Porto Alegre, CeP 90 610-000
Porto Alegre RS, 90020-090
Salvador, BA 41825-010
São Paulo, 05651-901
São Paulo, S01232-910
São Paulo, S01308-050
Canada (4)
Hamilton, Ontario
Toronto, Ontario
Novartis Investigative Site
Toronto, Ontario, M5G 2M9
Sainte-Foy, Quebec
Czechia (3)
Brno, 656 53
Prague, 128 08
Prague, 150 18
France (3)
Marseille, 13273
Marseille, 13385
Strasbourg, 6700
Germany (14)
Augsburg, 86150
Berlin, 13353
Berlin, 14195
Cologne, 50677
Dessau, 6822
Erlangen, 91054
Eschweiler, 52249
Essen, 45122
Frankfurt, 60488
Hanover, 30625
Heidelberg, 69115
Kiel, 24116
Leipzig, 4103
Magdeburg, 39002
Hungary (4)
Budapest, H-1032
Budapest, H-1097
Győr, H-9002
Szeged, H-6725
Italy (8)
Forlì, 47100
Genova, 16132
Milan, 20162
Modena, 41100
Roma, 135
Roma, 144
Rozzano, 20089
Torino, 10126
Netherlands (1)
GA Utrecht, 3508
New Zealand (2)
Novartis Investigative Site
Hamilton
Palmerston North
Portugal (1)
Coimbra, 3000-076
Slovakia (4)
Novartis Investigative Site
Bratislava, 81250
Novartis Investigative Site
Bratislava, 833 10
Novartis Investigative Site
Košice, 041 90
Novartis Investigative Site
Žilina, 012 07
Spain (6)
Alicante, 3202
Madrid, 28033
Madrid, 28035
Madrid, 28041
Málaga, 29010
Zaragoza, 50009
Sweden (1)
Stockholm, SE-118 83
Switzerland (5)
Basel, 4031
Bern, 3010
Thun, 3600
Zurich, 8027
Zurich, 8091
Taiwan (3)
Tainan
Taipei
Taoyuan District
United Kingdom (3)
Belfast, BT9 7AB
Leicester, LE1 5WW
Oxford, OX3 7LJ
United States (145)
Alabama Hematology/Oncology
Birmingham, Alabama, 35243
Palo Verde Hematology & Oncology
Glendale, Arizona, 85304
Arizona Cancer Center
Tucson, Arizona, 85724
Northeast Arkansas Clinic
Jonesboro, Arkansas, 72401
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
Ronald Yanagiharaa, M.D.
Gilroy, California, 95020
Glendale Adventist Medical Center Cancer Center
Glendale, California, 91206
Pacific Shores Medical Group
Long Beach, California, 90813
Cancer Institute Medical Group
Los Angeles, California, 90025
Synergy Hematology-Oncology Medical Associates
Los Angeles, California, 90057
UCLA School of Medicine
Los Angeles, California, 90095
USC/Norris Comprehensive Cancer Care Center
Los Angeles, California, 90033
Eddie Hong-Lung Hu, M.D.
Monterey Park, California, 91754
North Valley Hematology/Oncology Medical Group
Northridge, California, 91328
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030
Wilshire Oncology Medical Group
Pomona, California, 91767
Sierra View District Hospital
Porterville, California, 93257
The Lucy Curci Cancer Center
Rancho Mirage, California, 92270
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, 90277
Pacific Hematology Oncology Associates
San Francisco, California, 94904
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
Colorado Cancer Research Program
Denver, Colorado, 80224
Jennifer Caskey, M.D.
Wheat Ridge, Colorado, 08833
Davis, Posteraro and Wasser, MD's, LLP
Manchester, Connecticut, 06040
Connecticut Oncology Group
Middletown, Connecticut, 06457
Medical Oncology Hematology Consultants
Newark, Delaware, 19808
George Washington University Medical Center
Washington D.C., District of Columbia, 20037
Washington Oncology-Hematology Center
Washington D.C., District of Columbia, 20016
Boca Raton Comprehensive Cancer Center
Boca Raton, Florida, 33486
Florida Cancer Specialists
Fort Myers, Florida, 33901
Memorial Healthcare System
Hollywood, Florida, 33021
Florida Oncology Associates
Jacksonville, Florida, 32204
Lakeland Regional Cancer Center
Lakeland, Florida, 33803
Oncology Hematology Group of South Florida
Miami, Florida, 33176
Innovative Medical Research of South Florida
Miami Shores, Florida, 33138
Hematology Oncology Associates of Treasure
Port Saint Lucie, Florida, 34952
Florida Medical Clinic, PA
Zephyrhills, Florida, 33542
Peachtree Hematology and Oncology
Atlanta, Georgia, 40202
Coastal Hematology & Oncology
Savannah, Georgia, 31406
North Idaho Cancer Center
Coeur d'Alene, Idaho, 83814
Shelby D. Rifkin, M.D.
Arlington Heights, Illinois, 60004
Monroe Medical Associates
Harvey, Illinois, 60426
Oncology Hematology Associates of Central Illinois, PC
Peoria, Illinois, 61602
Midwest Cancer Research Group
Skokie, Illinois, 60077
Northshore Cancer Research Association
Skokie, Illinois, 60076
Hematology-Oncology of Indiana, PC
Indianapolis, Indiana, 46260
Associated Physicians & Surgeons Clinic, L.L.C.
Terre Haute, Indiana, 47804
Markey Clinical Oncology Research Program
Lexington, Kentucky, 40536-0098
Norton Healthcare Pavilion
Louisville, Kentucky, 40202
Vijay Raghavan, M.D.
Louisville, Kentucky, 40215
Louisiana Oncology Associates
Lafayette, Louisiana, 70506
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
St. Agnes Healthcare, Inc.
Baltimore, Maryland, 21229-5299
Kaiser Permanente
Rockville, Maryland, 20850
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106-0995
Josephine Ford Cancer Center
Detroit, Michigan, 48202
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Spectrum Health -- Cook Research Dept.
Grand Rapids, Michigan, 49503
Hematology and Oncology Assoc. of Southern Mississippi
Jackson, Michigan, 48201
Oncology Care Associates, PLLC
Saint Joseph, Michigan, 49085
Providence Cancer Center
Southfield, Michigan, 48075
SMDC Health System
Duluth, Minnesota, 55805
Minnesota CGOP
Minneapolis, Minnesota, 55407
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
Metro Minnesota CCOP
Saint Louis Park, Minnesota, 55426
Heartland Hematology/Oncology Associates, Inc.
Kansas City, Missouri, 64118
Kansas City Oncology and Hematology Group
Kansas City, Missouri, 64131
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
Montana Cancer Specialists
Missoula, Montana, 59807-7877
The Methodist Cancer Center
Omaha, Nebraska, 68114
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89109
Nevada Cancer Center
Las Vegas, Nevada, 89109
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, 08003
St. Barnabas Cancer Center
Livingston, New Jersey, 07039
Hematology-Oncology Associates of New Jersey
Morristown, New Jersey, 07960
Southern Oncology and Hematology Associates
Vineland, New Jersey, 08360
Cooper Cancer Institute
Voorhees Township, New Jersey, 08043
New Mexico Cancer Care
Santa Fe, New Mexico, 87505
Roswell Park Cancer Institute
Buffalo, New York, 14263
CR Wood Cancer Center
Glens Falls, New York, 12801
Cancer Research of Long Island
Great Neck, New York, 11023
Broome Oncology
Johnson City, New York, 13790
New York Oncology Hematology
Latham, New York, 12110
North Shore University Hospital
Manhasset, New York, 11030
Cancer Center at Nyack Hospital
Nyack, New York, 10960
Pluta Cancer Center
Rochester, New York, 14623
Carolina Medical Center
Charlotte, North Carolina, 28203
Mid-Dakota Clinic PC
Bismarck, North Dakota, 58501
Nashat Gabrail, M.D.
Canton, Ohio, 44718
Hematology Oncology Consultants, Inc.
Columbus, Ohio, 43235
Mid Ohio Oncology/Hematology, Inc.
Columbus, Ohio, 43213
Meridia Cancer Institute
Mayfield Heights, Ohio, 44124
Cancer Care Associates
Oklahoma City, Oklahoma, 73112
Cancer Care Associates
Tulsa, Oklahoma, 74136-1929
Kaiser Permanente Oncology Hematology
Portland, Oregon, 97227
Hershey Medical Center
Hershey, Pennsylvania, 17033
Monogahela Valley Hospital
Monongahela, Pennsylvania, 15063
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Allegheny Cancer Center
Pittsburgh, Pennsylvania, 15212-4772
Charleston Cancer Center
Charleston, South Carolina, 29406
Charleston Hematology Oncology
Charleston, South Carolina, 29403
South Carolina Oncology Associates
Columbia, South Carolina, 29201
Cancer Center of the Carolinas
Greenville, South Carolina, 29615
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
The Jones Clinic
Germantown, Tennessee, 38138
Baptist Regional Cancer Center
Knoxville, Tennessee, 37920
University of Tennessee Cancer Institute
Memphis, Tennessee, 38104
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
Southwest Regional Cancer Center
Austin, Texas, 78705
Corpus Christi Cancer Center
Corpus Christi, Texas, 78412
Center for Oncology Research & Treatment, PA
Dallas, Texas, 75230
H. Alejandro Preti, MD, PA
Houston, Texas, 77030
M.D. Anderson Cancer Center
Houston, Texas, 77030
Oncology Consultants
Houston, Texas, 77024
Dr. Lee C. Drinkard
Irving, Texas, 75038
Scott & White Hospital
Temple, Texas, 76508
North Utah Associates
Ogden, Utah, 84403-3105
Utah Cancer Specialists
Salt Lake City, Utah, 84124
Southwestern Vermont Health Care
Bennington, Vermont, 05201
Danville Hematology and Oncology, Inc.
Danville, Virginia, 24541
Northern Virginia Oncology Group
Fairfax, Virginia, 22031
Virginia Oncology Associates
Norfolk, Virginia, 23502
Cancer Treatment Centers of America
Portsmouth, Virginia, 23704
Virginia Cancer Institute
Richmond, Virginia, 23230
Western Washington Medical Group
Everett, Washington, 98201
Western Washington Medical Group
Everett, Washington, 982901
Cascade Cancer Center
Kirkland, Washington, 98034
UW Health -- University of Wisconsin Comp
Madison, Wisconsin, 53792
Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188