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NCT00101686

Ensayo de irinotecán en combinación con tres métodos de administración de fluoropirimidina.

Archived Fase 3

Descripción

Este estudio compara, en el primer período, la combinación de irinotecán con tres métodos de administración diferentes de fluoropirimidina (es decir, infusión, bolo y vía oral). En el segundo período del estudio, se compara FOLFIRI (un régimen de quimioterapia que combina irinotecán en bolo y leucovorina [LV] con 5-fluorouracilo [5-FU] en infusión) + bevacizumab y mlFL + bevacizumab. Se presentarán los resultados de eficacia y seguridad.

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:

  • Diagnóstico de cáncer colorrectal (ya sea de nueva aparición o enfermedad recurrente) con evidencia de enfermedad metastásica (estadio IV con enfermedad a distancia).
  • Documentación histológica actual o previa de adenocarcinoma de colon o recto. La localización de la lesión primaria debe estar confirmada o haber estado confirmada endoscópicamente, radiológicamente o quirúrgicamente en el intestino grueso. Los pacientes con antecedentes de cáncer colorrectal tratados con resección quirúrgica que desarrollan evidencia radiológica o clínica de cáncer metastásico no requieren una confirmación histológica o citológica separada de la enfermedad metastásica a menos que:
  • Haya transcurrido un intervalo mayor de cinco años entre la cirugía primaria y el desarrollo de la enfermedad metastásica.
  • El cáncer primario fue un Duke A o B1.
  • Los médicos deben considerar la posibilidad de realizar una biopsia de las lesiones para establecer el diagnóstico de cáncer colorrectal metastásico en cada caso, si existe una ambigüedad clínica importante con respecto a la naturaleza o el origen de las aparentes metástasis.

Criterios de exclusión:

  • Pacientes que hayan recibido alguna terapia antitumoral sistémica previa para el cáncer colorrectal metastásico (por ejemplo, quimioterapia, terapia con anticuerpos, inmunoterapia, terapia génica, terapia con vacunas, terapia con citocinas u otros agentes experimentales).
  • Los pacientes no pueden tener otras neoplasias malignas concurrentes al inicio del estudio.
  • Excepciones: Los pacientes con antecedentes de neoplasias malignas no colorrectales serán elegibles si han estado libres de enfermedad durante ≥ 3 años o si su médico tratante los considera de bajo riesgo de recurrencia (por ejemplo, cáncer de próstata en estadio temprano, melanoma o cáncer de vejiga). Los pacientes con carcinoma de células escamosas o basales de la piel o cáncer cervical in situ que hayan sido tratados eficazmente son elegibles, incluso si se diagnosticaron dentro de los 3 años anteriores a la aleatorización.

Información del Ensayo

NCT00101686
Archived
Fase 3
547 participantes
Feb 2003

Ubicaciones175

Australia (6)
Pfizer Investigational Site
Waratah, New South Wales, 2298
Pfizer Investigational Site
South Brisbane, Queensland, 4101
Pfizer Investigational Site
Bedford Park, South Australia, 5042
Pfizer Investigational Site
Woodville, South Australia, 5011
Pfizer Investigational Site
Clayton, Victoria, 3168
Pfizer Investigational Site
Frankston, Victoria, 3199
Canada (24)
Pfizer Investigational Site
Moncton, New Brunswick, E1C 8X3
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, A1B 3V76
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 2Y9
Pfizer Investigational Site
Sydney, Nova Scotia, B1P 1P3
Pfizer Investigational Site
Brampton, Ontario, L6W 3X4
Pfizer Investigational Site
Kingston, Ontario, K7L 5P9
Pfizer Investigational Site
Kitchener, Ontario, N2G 1G3
Pfizer Investigational Site
Mississauga, Ontario, L5B 1B8
Pfizer Investigational Site
Newmarket, Ontario, L3Y 2P9
Pfizer Investigational Site
Oshawa, Ontario, L1G 2B9
Pfizer Investigational Site
Ottawa, Ontario, K1H 1C4
Pfizer Investigational Site
Scarborough Village, Ontario, M1P 2V5
Pfizer Investigational Site
Thunder Bay, Ontario, P7A 7T1
Pfizer Investigational Site
Windsor, Ontario, N8W 2X3
Pfizer Investigational Site
Chicoutimi, Quebec, G7H 5H6
Pfizer Investigational Site
Fleurimont, Quebec, J1H 5N4
Pfizer Investigational Site
Laval, Quebec, H7M 3L9
Pfizer Investigational Site
Montreal, Quebec, H1T 4B3
Pfizer Investigational Site
Montreal, Quebec, H2W 1S6
Pfizer Investigational Site
Montreal, Quebec, H2X 3J4
Pfizer Investigational Site
Québec, Quebec
Pfizer Investigational Site
Rimouski, Quebec, G5L 5T1
Pfizer Investigational Site
Regina, Saskatchewan, S4T 7T1
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7N 4H4
New Zealand (4)
Pfizer Investigational Site
Auckland, 1
Pfizer Investigational Site
Dunedin, 9001
Pfizer Investigational Site
Riccarton, 8020
Pfizer Investigational Site
Wellington, 6039
United States (141)
Pfizer Investigational Site
Birmgingham, Alabama, 35205
Pfizer Investigational Site
Birmingham, Alabama, 35205
Pfizer Investigational Site
Birmngham, Alabama, 35211
Pfizer Investigational Site
Mobile, Alabama, 36608
Pfizer Investigational Site
Flagstaff, Arizona, 86001
Pfizer Investigational Site
Sedona, Arizona, 86336
Pfizer Investigational Site
Tucson, Arizona, 85712
Pfizer Investigational Site
Hot Spring, Arkansas, 71913
Pfizer Investigational Site
Springdale, Arkansas, 72764
Pfizer Investigational Site
Arroyo Grande, California, 93420
Pfizer Investigational Site
Fountian Valley, California, 92708
Pfizer Investigational Site
Fresno, California, 93710
Pfizer Investigational Site
Los Gatos, California, 95032
Pfizer Investigational Site
Mission Hills, California, 91345
Pfizer Investigational Site
Modesto, California, 95355
Pfizer Investigational Site
Orange, California, 92868
Pfizer Investigational Site
Oxnard, California, 93030
Pfizer Investigational Site
San Diego, California, 92123
Pfizer Investigational Site
San Jose, California, 95125
Pfizer Investigational Site
Boulder, Colorado, 80304
Pfizer Investigational Site
Norwalk, Connecticut, 06581
Pfizer Investigational Site
Stamford, Connecticut, 06902-3628
Pfizer Investigational Site
Washington D.C., District of Columbia, 20007
Pfizer Investigational Site
Altamonte Springs, Florida, 32701
Pfizer Investigational Site
Hollywood, Florida, 33021
Pfizer Investigational Site
Lauderhill, Florida, 33319
Pfizer Investigational Site
Miami, Florida, 33133
Pfizer Investigational Site
Miami Beach, Florida
Pfizer Investigational Site
New Port Richey, Florida, 34652
Pfizer Investigational Site
Ocala, Florida, 34474
Pfizer Investigational Site
Sarasota, Florida, 34239
Pfizer Investigational Site
Tamarac, Florida, 33321
Pfizer Investigational Site
Macon, Georgia, 31201
Pfizer Investigational Site
Niles, Illinois, 60714
Pfizer Investigational Site
Rockford, Illinois, 61108-2472
Pfizer Investigational Site
Skokie, Illinois, 60077
Pfizer Investigational Site
Fishers, Indiana, 46038
Pfizer Investigational Site
Fort Wayne, Indiana, 46815
Pfizer Investigational Site
Terre Haute, Indiana, 47802
Pfizer Investigational Site
Overland Park, Kansas, 66210
Pfizer Investigational Site
Alexandria, Louisiana, 71301
Pfizer Investigational Site
Shrevport, Louisiana, 71101
Pfizer Investigational Site
Bangor, Maine, 04401
Pfizer Investigational Site
Annapolis, Maryland, 21401
Pfizer Investigational Site
Boston, Massachusetts, 02114
Pfizer Investigational Site
Boston, Massachusetts, 02115
Pfizer Investigational Site
Boston, Massachusetts, 02215
Pfizer Investigational Site
Burlington, Massachusetts, 01805
Pfizer Investigational Site
Pittsfield, Massachusetts, 01201
Pfizer Investigational Site
Grand Rapids, Michigan, 49603
Pfizer Investigational Site
Burnsville, Minnesota, 55337
Pfizer Investigational Site
Robbinsdale, Minnesota, 55422
Pfizer Investigational Site
Columbia, Missouri, 65201
Pfizer Investigational Site
Columbia, Missouri, 65203
Pfizer Investigational Site
Joplin, Missouri, 64804
Pfizer Investigational Site
St Louis, Missouri, 63136
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
Billings, Montana, 59101
Pfizer Investigational Site
Omaha, Nebraska, 68131
Pfizer Investigational Site
Las Vegas, Nevada, 89109
Pfizer Investigational Site
Hooksett, New Hampshire, 03106
Pfizer Investigational Site
Lebanon, New Hampshire, 03756-0001
Pfizer Investigational Site
Nashua, New Hampshire, 03060
Pfizer Investigational Site
Summit, New Jersey, 07901
Pfizer Investigational Site
Albuquerque, New Mexico, 87109
Pfizer Investigational Site
Farmington, New Mexico, 87401
Pfizer Investigational Site
Santa Fe, New Mexico, 87501
Pfizer Investigational Site
Albany, New York, 12208
Pfizer Investigational Site
Manhaset, New York, 11030
Pfizer Investigational Site
Rockville Centre, New York, 11570
Pfizer Investigational Site
Asheville, North Carolina, 28801
Pfizer Investigational Site
Cary, North Carolina, 27511
Pfizer Investigational Site
Fayetteville, North Carolina, 28302-2000
Pfizer Investigational Site
Greensboro, North Carolina, 27403
Pfizer Investigational Site
Hendersonville, North Carolina, 28791
Pfizer Investigational Site
Hickory, North Carolina, 28602
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
Pfizer Investigational Site
Winston-Salem, North Carolina, 27157
Pfizer Investigational Site
Columbus, Ohio, 43215
Pfizer Investigational Site
Dayton, Ohio, 45409
Pfizer Investigational Site
Bartlesville, Oklahoma, 74006
Pfizer Investigational Site
Norman, Oklahoma, 73071
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73104
Pfizer Investigational Site
Eugene, Oregon, 97401
Pfizer Investigational Site
Portland, Oregon, 97213
Pfizer Investigational Site
Abington, Pennsylvania, 19001
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19014-4283
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19107
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19141
Pfizer Investigational Site
Reading, Pennsylvania, 19603
Pfizer Investigational Site
Chattanooga, Tennessee, 37404
Pfizer Investigational Site
Collierville, Tennessee, 38017
Pfizer Investigational Site
Germantown, Tennessee, 38138
Pfizer Investigational Site
Jackson, Tennessee, 38301
Pfizer Investigational Site
Knoxville, Tennessee, 37916
Pfizer Investigational Site
Knoxville, Tennessee, 37920
Pfizer Investigational Site
Abilene, Texas, 79606-5208
Pfizer Investigational Site
Arlington, Texas, 76012
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Austin, Texas, 78731
Pfizer Investigational Site
Beaumont, Texas, 77702-1449
Pfizer Investigational Site
Bedford, Texas, 76022
Pfizer Investigational Site
Dallas, Texas, 75230-2510
Pfizer Investigational Site
Dallas, Texas, 75231-4400
Pfizer Investigational Site
Dallas, Texas, 75237
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Denton, Texas, 76210
Pfizer Investigational Site
El Paso, Texas, 79902
Pfizer Investigational Site
El Paso, Texas, 79915
Pfizer Investigational Site
Fort Worth, Texas, 76104
Pfizer Investigational Site
Fredericksburg, Texas, 78624-3847
Pfizer Investigational Site
Garland, Texas, 75042
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Houston, Texas, 77054
Pfizer Investigational Site
Irving, Texas, 75061-224
Pfizer Investigational Site
Lewisville, Texas, 75067
Pfizer Investigational Site
Longview, Texas, 75601
Pfizer Investigational Site
McAllen, Texas, 78503
Pfizer Investigational Site
Mesquite, Texas, 75050
Pfizer Investigational Site
Midland, Texas, 79701
Pfizer Investigational Site
New Braunfels, Texas, 78130
Pfizer Investigational Site
Odessa, Texas, 79761
Pfizer Investigational Site
Paris, Texas, 75460
Pfizer Investigational Site
Sherman, Texas, 75090-0504
Pfizer Investigational Site
Temple, Texas, 76508
Pfizer Investigational Site
Tyler, Texas, 75701-2001
Pfizer Investigational Site
Tyler, Texas, 75702
Pfizer Investigational Site
Waco, Texas, 76712
Pfizer Investigational Site
Webster, Texas, 77598
Pfizer Investigational Site
Wichita Falls, Texas, 76310
Pfizer Investigational Site
Colchester, Vermont, 05446
Pfizer Investigational Site
Fairfax, Virginia, 22031
Pfizer Investigational Site
Newport News, Virginia, 23606
Pfizer Investigational Site
Roanoke, Virginia, 24014
Pfizer Investigational Site
Edmonds, Washington, 98026
Pfizer Investigational Site
Lacy, Washington, 98503
Pfizer Investigational Site
Seattle, Washington, 98133
Pfizer Investigational Site
Spokane, Washington, 99202
Pfizer Investigational Site
Yakima, Washington, 98902
Pfizer Investigational Site
Glendale, Wisconsin, 53212
Pfizer Investigational Site
Milwaukee, Wisconsin, 53226

Fuente Oficial

Ver en ClinicalTrials.gov