- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00006786
Combination Chemotherapy Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer
Phase II Trial of Fluorouracil (5-FU), Leucovorin (LV), Irinotecan (CPT-11) and Bevacizumab (Anti-VEGF) in Previously Untreated Patients With Advanced Colorectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bevacizumab may stop the growth of colorectal cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus bevacizumab in treating patients who have advanced colorectal cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES: I. Determine the progression-free survival at 7 months of patients with previously untreated advanced colorectal cancer treated with fluorouracil, leucovorin calcium, irinotecan, and bevacizumab. II. Determine the response rate and overall survival of this patient population treated with this regimen. III. Determine the toxicity of this treatment regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV once weekly for 4 weeks. Patients also receive bevacizumab IV over 30-90 minutes once every 2 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 1 year.
Tipo de estudio
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Arizona
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Scottsdale, Arizona, Estados Unidos, 85259-5404
- CCOP - Scottsdale Oncology Program
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California
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Duarte, California, Estados Unidos, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
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Palo Alto, California, Estados Unidos, 94304
- Veterans Affairs Medical Center - Palo Alto
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Stanford, California, Estados Unidos, 94305-5408
- Stanford University Medical Center
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Colorado
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Denver, Colorado, Estados Unidos, 80209-5031
- CCOP - Colorado Cancer Research Program, Inc.
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Delaware
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Wilmington, Delaware, Estados Unidos, 19899
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20307-5000
- Walter Reed Army Medical Center
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Washington, District of Columbia, Estados Unidos, 20060
- MBCCOP-Howard University Cancer Center
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Florida
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Gainesville, Florida, Estados Unidos, 32608-1197
- Veterans Affairs Medical Center - Gainsville
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Miami, Florida, Estados Unidos, 33125
- Veterans Affairs Medical Center - Miami
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Tampa, Florida, Estados Unidos, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Tampa, Florida, Estados Unidos, 33612
- Veterans Affairs Medical Center - Tampa (Haley)
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University Hospital - Atlanta
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Decatur, Georgia, Estados Unidos, 30033
- Veterans Affairs Medical Center - Atlanta (Decatur)
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Illinois
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Chicago, Illinois, Estados Unidos, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
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Chicago, Illinois, Estados Unidos, 60611
- Veterans Affairs Medical Center - Lakeside Chicago
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Decatur, Illinois, Estados Unidos, 62526
- CCOP - Central Illinois
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Evanston, Illinois, Estados Unidos, 60201
- CCOP - Evanston
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Peoria, Illinois, Estados Unidos, 61602
- CCOP - Illinois Oncology Research Association
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Urbana, Illinois, Estados Unidos, 61801
- CCOP - Carle Cancer Center
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202-5289
- Indiana University Cancer Center
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Indianapolis, Indiana, Estados Unidos, 46202
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
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Iowa
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Cedar Rapids, Iowa, Estados Unidos, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, Estados Unidos, 50309-1016
- CCOP - Iowa Oncology Research Association
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Iowa City, Iowa, Estados Unidos, 52242-1009
- Holden Comprehensive Cancer Center at the University of Iowa
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Kansas
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Wichita, Kansas, Estados Unidos, 67218
- Veterans Affairs Medical Center - Wichita
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70121
- CCOP - Ochsner
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New Orleans, Louisiana, Estados Unidos, 70112
- MBCCOP - LSU Health Sciences Center
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Maryland
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Baltimore, Maryland, Estados Unidos, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Estados Unidos, 02111
- New England Medical Center Hospital
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48106
- CCOP - Ann Arbor Regional
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Kalamazoo, Michigan, Estados Unidos, 49007-3731
- CCOP - Kalamazoo
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Minnesota
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Duluth, Minnesota, Estados Unidos, 55805
- CCOP - Duluth
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Minneapolis, Minnesota, Estados Unidos, 55417
- Veterans Affairs Medical Center - Minneapolis
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Minneapolis, Minnesota, Estados Unidos, 55455
- University of Minnesota Cancer Center
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, Estados Unidos, 55416
- CCOP - Metro-Minnesota
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68131
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, Estados Unidos, 68105
- Veterans Affairs Medical Center - Omaha
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Jersey
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East Orange, New Jersey, Estados Unidos, 07018-1095
- Veterans Affairs Medical Center - East Orange
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Hackensack, New Jersey, Estados Unidos, 07601
- CCOP - Northern New Jersey
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New Brunswick, New Jersey, Estados Unidos, 08901
- Cancer Institute of New Jersey
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New York
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Albany, New York, Estados Unidos, 12208
- Veterans Affairs Medical Center - Albany
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Bronx, New York, Estados Unidos, 10461
- Albert Einstein Comprehensive Cancer Center
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Bronx, New York, Estados Unidos, 10466
- MBCCOP-Our Lady of Mercy Cancer Center
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Brooklyn, New York, Estados Unidos, 11209
- Veterans Affairs Medical Center - Brooklyn
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New York, New York, Estados Unidos, 10016
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
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New York, New York, Estados Unidos, 10010
- Veterans Affairs Medical Center - New York
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Rochester, New York, Estados Unidos, 14642
- University of Rochester Cancer Center
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North Dakota
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Fargo, North Dakota, Estados Unidos, 58122
- CCOP - Merit Care Hospital
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Estados Unidos, 44106-5065
- Ireland Cancer Center
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Cleveland, Ohio, Estados Unidos, 44106
- Veterans Affairs Medical Center - Cleveland
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Columbus, Ohio, Estados Unidos, 43206
- CCOP - Columbus
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Toledo, Ohio, Estados Unidos, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74136
- CCOP - Sooner State
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Pennsylvania
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Danville, Pennsylvania, Estados Unidos, 17822-2001
- CCOP - Geisinger Clinic and Medical Center
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Philadelphia, Pennsylvania, Estados Unidos, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, Estados Unidos, 19102-1192
- Hahnemann University Hospital
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Philadelphia, Pennsylvania, Estados Unidos, 19104-4283
- University of Pennsylvania Cancer Center
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Philadelphia, Pennsylvania, Estados Unidos, 19104-9104
- University of Pennsylvania Health Systems
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Pittsburgh, Pennsylvania, Estados Unidos, 15213-3489
- University of Pittsburgh Cancer Institute
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Pittsburgh, Pennsylvania, Estados Unidos, 15240
- Veterans Affairs Medical Center - Pittsburgh
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Wynnewood, Pennsylvania, Estados Unidos, 19096
- CCOP - MainLine Health
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South Dakota
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Sioux Falls, South Dakota, Estados Unidos, 57105-1080
- CCOP - Sioux Community Cancer Consortium
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Nashville, Tennessee, Estados Unidos, 37212
- Veterans Affairs Medical Center - Nashville
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
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Madison, Wisconsin, Estados Unidos, 53705
- Veterans Affairs Medical Center - Madison
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Marshfield, Wisconsin, Estados Unidos, 54449
- CCOP - Marshfield Medical Research and Education Foundation
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Medical College of Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53295
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
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San Juan, Puerto Rico, 00927-5800
- MBCCOP - San Juan
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San Juan, Puerto Rico, 00927-5800
- Veterans Affairs Medical Center - San Juan
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Pretoria, Sudáfrica, 0001
- Pretoria Academic Hospitals
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS: Histologically confirmed advanced or metastatic adenocarcinoma of the colon and rectum Surgically unresectable disease Measurable disease Disease outside the prior radiotherapy port and/or progressive disease within the previously irradiated volume
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 No hemorrhagic events within the past 6 months Hepatic: Bilirubin normal SGOT normal INR no greater than 1.5 Renal: Creatinine no greater than 1.5 times upper limit of normal Cardiovascular: No thromboembolic events within the past 6 months Pulmonary: No evidence of pneumonia Other: No known hypersensitivity to recombinant humanized murine monoclonal antibodies No evidence of significant active infection (e.g., peritonitis or wound abscess) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent sargramostim (GM-CSF) Chemotherapy: At least 12 months since prior fluorouracil-based adjuvant chemotherapy No prior adjuvant irinotecan Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics Other: No prior therapy for advanced disease No concurrent therapeutic anticoagulation except for low-dose coumadin for maintenance of indwelling catheters
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Bruce J. Giantonio, MD, Presbyterian Medical Center
Publicaciones y enlaces útiles
Publicaciones Generales
- Gray R, Giantonio BJ, O'Dwyer PJ, et al.: The safety of adding angiogenesis inhibition into treatment for colorectal, breast, and lung cancer: the Eastern Cooperative Oncology Group's (ECOG) experience with bevacizumab (anti-VEGF). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-825, 2003.
- Giantonio BJ, Chen HX, Catalano PJ, et al.: Bowel perforation and fistula formation in colorectal cancer patients treated on Eastern Cooperative Oncology Group (ECOG) studies E2200 and E3200. [Abstract] J Clin Oncol 22 (Suppl 14): A-3017, 199s, 2004.
- Giantonio BJ, Levy DE, O'dwyer PJ, Meropol NJ, Catalano PJ, Benson AB 3rd; Eastern Cooperative Oncology Group. A phase II study of high-dose bevacizumab in combination with irinotecan, 5-fluorouracil, leucovorin, as initial therapy for advanced colorectal cancer: results from the Eastern Cooperative Oncology Group study E2200. Ann Oncol. 2006 Sep;17(9):1399-403. doi: 10.1093/annonc/mdl161. Epub 2006 Jul 27.
- Giantonio BJ, Levy D, O'Dwyer PJ, et al.: Bevacizumab (anti-VEGF) plus IFL (irinotecan, fluorouracil, leucovorin) as front-line therapy for advanced colorectal cancer (advCRC): results from the Eastern Cooperative Oncology Group (ECOG) Study E2200. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1024, 2003.
- Giantonio BJ, Levy D, Catalano PJ, et al.: Incorporating angiogenesis inhibition with bevacizumab (anti-VEGF) into frontline chemotherapy with irinotecan (CPT-11), fluorouracil and leucovorin (FU/LV) for advanced colorectal cancer (advCRC): a toxicity analysis of ECOG study E2200. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-503, 2002.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Neoplasias
- Neoplasias por sitio
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades del Colon
- Enfermedades intestinales
- Neoplasias Intestinales
- Enfermedades Rectales
- Neoplasias colorrectales
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes Protectores
- Inhibidores de la topoisomerasa
- Agentes antineoplásicos inmunológicos
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Micronutrientes
- Vitaminas
- Hormonas y agentes reguladores del calcio
- Inhibidores de la topoisomerasa I
- Antídotos
- Complejo de vitamina B
- Fluorouracilo
- Bevacizumab
- Leucovorina
- Irinotecán
- Calcio
- Levoleucovorina
Otros números de identificación del estudio
- CDR0000068328
- ECOG-E2200
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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