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NCT00063141
Estudio de irinotecán y cetuximab frente a irinotecán como tratamiento de segunda línea en pacientes con cáncer colorrectal metastásico y EGFR positivo.
Archived
Fase 3
Descripción
El objetivo de este estudio es determinar si la supervivencia global se prolonga en pacientes con cáncer colorrectal metastásico, positivo para el receptor del factor de crecimiento epidérmico (EGFR), tratados con cetuximab en combinación con irinotecán, en comparación con el tratamiento con irinotecán solo, como terapia de segunda línea tras el tratamiento con un régimen basado en fluoropirimidina y oxaliplatino que no contenga irinotecán.
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:
- Cáncer colorrectal histológicamente confirmado, que sea EGFR-positivo según inmunohistoquímica \[IHC] (puede basarse en muestras de archivo) y que sea metastásico.
- Administración previa de oxaliplatino para el tratamiento de primera línea del cáncer colorrectal metastásico.
- Administración previa de un régimen que contenga fluoropirimidina (5-fluorouracilo \[5-FU], capecitabina o uracilo/tegafur \[UFT]) para el tratamiento de primera línea de la enfermedad metastásica.
Criterios de exclusión:
- Un trastorno médico grave no controlado que, en opinión del investigador, impida la capacidad del sujeto para recibir la terapia del protocolo.
- Diarrea no resuelta, obstrucción intestinal o antecedentes de enfermedad inflamatoria intestinal.
- Metástasis cerebrales conocidas o documentadas.
Información del Ensayo
NCT00063141
Archived
Fase 3
1302 participantes
Abr 2003
Ubicaciones188
Australia (7)
ImClone Investigational Site
Wien
ImClone Investigational Site
Perth, Australian Capital Territory
ImClone Investigational Site
Sydney, Australian Capital Territory
ImClone Investigational Site
Sydney, New South Wales
ImClone Investigational Site
Wollongong, New South Wales
ImClone Investigational Site
South Brisbane, Queensland
ImClone Investigational Site
Adelaide, South Australia
Austria (4)
ImClone Investigational Site
Graz
ImClone Investigational Site
Salzburg
ImClone Investigational Site
Vienna
ImClone Investigational Site
Wein
Belgium (1)
ImClone Investigational Site
Charleroi
Czechia (3)
ImClone Investigational Site
Brno
ImClone Investigational Site
Olomouc
ImClone Investigational Site
Prague
Finland (1)
ImClone Investigational Site
Helsinki
France (4)
ImClone Investigational Site
Avignon
ImClone Investigational Site
Marseille
ImClone Investigational Site
Nice
ImClone Investigational Site
Saint-Herblain
Germany (18)
ImClone Investigational Site
Aschaffenburg
ImClone Investigational Site
Augsburg
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Dessau
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Dortmund
ImClone Investigational Site
Essen
ImClone Investigational Site
Hamburg
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Hanburg
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Kaiserslautern
ImClone Investigational Site
Kassel
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Magdeburg
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Mainz
ImClone Investigational Site
Mannheim
ImClone Investigational Site
Muchnhen
ImClone Investigational Site
München
ImClone Investigational Site
Regensburg
ImClone Investigational Site
Saarbrücken
ImClone Investigational Site
Stralsund
ImClone Investigational Site
Stuttgart
Hong Kong (1)
ImClone Investigational Site
Hong Kong
Italy (14)
ImClone Investigational Site
Ancona
ImClone Investigational Site
Bergamo
ImClone Investigational Site
Candiolo
ImClone Investigational Site
Florence
ImClone Investigational Site
Genova
ImClone Investigational Site
Livomo
ImClone Investigational Site
Milan
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Modena
ImClone Investigational Site
Napoli
ImClone Investigational Site
Perugia
ImClone Investigational Site
Reggio Emilia
ImClone Investigational Site
Roma
ImClone Investigational Site
Rome
ImClone Investigational Site
Rozzano, Milano
Netherlands (2)
ImClone Investigational Site
Apeldoorn
ImClone Investigational Site
Dordrecht
Norway (2)
ImClone Investigational Site
Oslo
ImClone Investigational Site
Montebello, Oslo County
Portugal (1)
ImClone Investigational Site
Porto
Slovakia (1)
ImClone Investigational Site
Bratislava
Sweden (2)
ImClone Investigational Site
Lund
ImClone Investigational Site
Stockholm
Switzerland (3)
ImClone Investigational Site
Bern
ImClone Investigational Site
Liestal
ImClone Investigational Site
Zurich
United Kingdom (8)
ImClone Investigational Site
Foresterhill, Aberdeenshire
ImClone Investigational Site
Hull, Avon
ImClone Investigational Site
Glasgow, Central
ImClone Investigational Site
Poole, Dorset
ImClone Investigational Site
London, Greater London
ImClone Investigational Site
Bournemouth, Hampshire
ImClone Investigational Site
Guildford, Surrey
ImClone Investigational Site
Sutton, Surrey
United States (116)
ImClone Investigational Site
Tucson, Arizona, 85712
ImClone Investigational Site
Pine Bluff, Arkansas, 71603
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Bakersfield, California, 93309
ImClone Investigational Site
Berkeley, California, 94704
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Beverly Hills, California, 90211
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Corona, California, 92708
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Gilroy, California, 95020
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Greenbrae, California, 95904
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Long Beach, California, 90813
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Los Angeles, California, 90033
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Los Angeles, California, 90057
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Montebello, California, 90640
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Orange, California, 92868
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Palm Springs, California, 92262
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Rancho Mirage, California, 92270
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San Diego, California, 92120
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Stockton, California, 95204
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Vallejo, California, 94589
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Aurora, Colorado, 80012
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Denver, Colorado, 80218
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New Haven, Connecticut, 06520
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New London, Connecticut, 06320
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Norwich, Connecticut, 06360
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Stamford, Connecticut, 06902
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Fort Myers, Florida, 33901
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Fort Myers, Florida, 33990
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Inverness, Florida, 34452
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Jacksonville, Florida, 32207
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Jacksonville, Florida, 32209
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Jacksonville, Florida, 32224
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Lakeland, Florida, 33805
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Miami, Florida, 33136
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New Port Richey, Florida, 34652
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Orlando, Florida, 32806
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Port Saint Lucie, Florida, 34952
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Atlanta, Georgia, 30309
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Atlanta, Georgia, 30322
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Columbus, Georgia, 31902-0951
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Macon, Georgia, 31201
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Savannah, Georgia, 31405
ImClone Investigational Site
Tucker, Georgia, 30342
ImClone Investigational Site
Honolulu, Hawaii, 96813
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Naperville, Illinois, 60540
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South Bend, Indiana, 46601
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Kansas City, Kansas, 66160
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Overland Park, Kansas, 66214
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Lexington, Kentucky, 40536-0098
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Louisville, Kentucky, 40202
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Richmond, Kentucky, 40475
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Baton Rouge, Louisiana, 70808
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Lafayette, Louisiana, 70506
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Metairie, Louisiana, 70006
ImClone Investigational Site
Shreveport, Louisiana, 71103
ImClone Investigational Site
Baltimore, Maryland, 21204
ImClone Investigational Site
Frederick, Maryland, 21701
ImClone Investigational Site
Boston, Massachusetts, 02135
ImClone Investigational Site
Ann Arbor, Michigan, 48106
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Detroit, Michigan, 48201
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Southfield, Michigan, 48075
ImClone Investigational Site
Minneapolis, Minnesota, 55407-3799
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Robbinsdale, Minnesota, 55422
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Saint Louis Park, Minnesota, 55426
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Jackson, Mississippi, 39202
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Kansas City, Missouri, 64111
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Rolla, Missouri, 65401
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St Louis, Missouri, 63110
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Trenton, New Jersey, 08690
ImClone Investigational Site
Voorhees Township, New Jersey, 08084
ImClone Investigational Site
Albany, New York, 12208
ImClone Investigational Site
East Setauket, New York, 11733
ImClone Investigational Site
Latham, New York, 12110
ImClone Investigational Site
Mineola, New York, 11501
ImClone Investigational Site
New York, New York, 10016
ImClone Investigational Site
Rexford, New York, 12148
ImClone Investigational Site
Stony Brook, New York, 11794
ImClone Investigational Site
The Bronx, New York, 10466
ImClone Investigational Site
Valhalla, New York, 10595
ImClone Investigational Site
Durham, North Carolina, 27710
ImClone Investigational Site
Greenville, North Carolina, 27834
ImClone Investigational Site
High Point, North Carolina, 27262
ImClone Investigational Site
Raleigh, North Carolina, 27609
ImClone Investigational Site
Winston-Salem, North Carolina, 27103
ImClone Investigational Site
Winston-Salem, North Carolina, 27157
ImClone Investigational Site
Bismarck, North Dakota, 58501
ImClone Investigational Site
Cincinnati, Ohio, 45267
ImClone Investigational Site
Cleveland, Ohio, 44106
ImClone Investigational Site
Columbus, Ohio, 43235
ImClone Investigational Site
Dayton, Ohio, 45459
ImClone Investigational Site
Newark, Ohio, 43055
ImClone Investigational Site
Oklahoma City, Oklahoma, 73118
ImClone Investigational Site
Hershey, Pennsylvania, 17033
ImClone Investigational Site
Philadelphia, Pennsylvania, 19106
ImClone Investigational Site
Philadelphia, Pennsylvania, 19107
ImClone Investigational Site
Philadelphia, Pennsylvania, 19141-3098
ImClone Investigational Site
Pittsburgh, Pennsylvania, 15232
ImClone Investigational Site
Greenville, South Carolina, 29615
ImClone Investigational Site
Knoxville, Tennessee, 37916
ImClone Investigational Site
Memphis, Tennessee, 38120
ImClone Investigational Site
Nashville, Tennessee, 37203
ImClone Investigational Site
Austin, Texas, 78759
ImClone Investigational Site
Dallas, Texas, 75230
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Houston, Texas, 77030
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Plano, Texas, 75075
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Temple, Texas, 76508
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Ogden, Utah, 84403
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Arlington, Virginia, 22205
ImClone Investigational Site
Danville, Virginia, 24541
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Newport News, Virginia, 23606
ImClone Investigational Site
Richmond, Virginia, 23230
ImClone Investigational Site
Seattle, Washington, 98104
ImClone Investigational Site
Spokane, Washington, 99204
ImClone Investigational Site
Spokane, Washington, 99218
ImClone Investigational Site
Walla Walla, Washington, 99362
ImClone Investigational Site
Green Bay, Wisconsin, 54301
ImClone Investigational Site
Madison, Wisconsin, 53792
ImClone Investigational Site
Milwaukee, Wisconsin, 53226