- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00066846
Bevacizumab Plus Fluorouracil and Leucovorin in Treating Patients With Locally Advanced or Metastatic Stage IV Colorectal Cancer That Has Progressed After Standard Chemotherapy
A Multicenter Study of the Anti-VEGF Monoclonal Antibody Bevacizumab (Avastin®) Plus 5-Fluorouracil/Leucovorin in Patients With Metastatic Colorectal Cancers That Have Progressed After Standard Chemotherapy
RATIONALE: Bevacizumab may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy such as fluorouracil and leucovorin use different ways to stop tumor cells from dividing so they stop growing or die. Combining bevacizumab with fluorouracil and leucovorin may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining bevacizumab with fluorouracil and leucovorin in treating patients who have locally advanced or metastatic stage IV colorectal cancer that has progressed after standard chemotherapy.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- Determine the response rate of patients treated with bevacizumab, fluorouracil, and leucovorin calcium for stage IV colorectal cancer that has progressed after standard chemotherapy.
- Determine the time to progression and overall survival of patients treated with this regimen.
- Determine the safety of administering "bolus" and continuous infusion fluorouracil and leucovorin calcium in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study. Patients receive 1 of 2 treatment regimens.
- Regimen I: Patients receive bevacizumab IV on days 1, 15, 29, and 42 (every 2 weeks) and leucovorin calcium (CF) IV over 2 hours and fluorouracil (5-FU) IV bolus on days 1, 8, 15, 22, 29, and 36.
- Regimen II: Patients receive bevacizumab as in regimen I and CF IV over 2 hours and 5-FU IV bolus followed by a continuous infusion over 22 hours on days 1, 2, 15, 16, 29, 30, 43, and 44.
For both regimens, courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for tumor response and survival.
PROJECTED ACCRUAL: Various NCI-designated Clinical Cancer Centers and other medical institutions across the United States will participate in this study. A total of 35-125 patients will be accrued for this study within 3 months.
Tipo de estudio
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Alaska
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Anchorage, Alaska, Estados Unidos, 99519-6604
- Providence Alaska Medical Center
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California
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Los Angeles, California, Estados Unidos, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, Estados Unidos, 90024
- Jonsson Comprehensive Cancer Center, UCLA
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Colorado
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Aurora, Colorado, Estados Unidos, 80010
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06520-8028
- Yale Comprehensive Cancer Center
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20007
- Lombardi Cancer Center
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Georgia
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Atlanta, Georgia, Estados Unidos, 30342-1701
- CCOP - Atlanta Regional
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
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Maywood, Illinois, Estados Unidos, 60153
- Loyola University Medical Center
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242-1009
- Holden Comprehensive Cancer Center
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Sioux City, Iowa, Estados Unidos, 51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita, Kansas, Estados Unidos, 67214-3882
- CCOP - Wichita
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Maine
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Bangor, Maine, Estados Unidos, 04401
- Cancer Care of Maine
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48106
- Saint Joseph Mercy Health System
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Minnesota
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Duluth, Minnesota, Estados Unidos, 55805
- St. Mary's/Duluth Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Estados Unidos, 39216-4505
- University of Mississippi Medical Center
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Montana
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Billings, Montana, Estados Unidos, 59101
- CCOP - Montana Cancer Consortium
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89106
- Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756-0002
- Norris Cotton Cancer Center
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New York
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Buffalo, New York, Estados Unidos, 14263-0001
- Roswell Park Cancer Institute
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New York, New York, Estados Unidos, 10021
- New York Weill Cornell Cancer Center at Cornell University
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, Estados Unidos, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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North Dakota
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Fargo, North Dakota, Estados Unidos, 58122
- Meritcare Roger Maris Cancer Center
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Ohio
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Cleveland, Ohio, Estados Unidos, 44106-5065
- Ireland Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- University of Oklahoma Health Sciences Center
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Abramson Cancer Center of the University of Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107-5541
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
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South Dakota
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Sioux Falls, South Dakota, Estados Unidos, 57104
- Sioux Valley Clinics - Oncology
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Vermont
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Burlington, Vermont, Estados Unidos, 05401
- Fletcher Allen Health Care - University Health Center Campus
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Virginia
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Richmond, Virginia, Estados Unidos, 23298-0037
- Massey Cancer Center
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Washington
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Seattle, Washington, Estados Unidos, 98109
- Seattle Cancer Care Alliance
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Seattle, Washington, Estados Unidos, 98101
- CCOP - Virginia Mason Research Center
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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 or cytologically confirmed colorectal adenocarcinoma
- Stage IV (metastatic) disease
- Not curable by surgery or radiotherapy
Must have received prior standard chemotherapy regimens, including oxaliplatin and irinotecan, and meet both of the following criteria:
- Disease progression during or after irinotecan-based chemotherapy for metastatic disease OR relapsed disease within 6 months after adjuvant irinotecan-based therapy
- Disease progression during or after oxaliplatin-based chemotherapy for metastatic disease OR relapsed disease within 6 months after adjuvant oxaliplatin-based therapy
- No brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL (transfusion allowed)
- No evidence of bleeding diathesis or coagulopathy
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- AST less than 5 times upper limit of normal (ULN)
- Alkaline phosphatase less than 5 times ULN
- PT and INR no greater than 1.5 times ULN
- PTT no greater than ULN
Renal
- Creatinine no greater than 1.5 times ULN
- Proteinuria less than grade 1 OR
- Proteinuria less than 500 mg/24 hours
Cardiovascular
- No prior stroke
- No uncontrolled high blood pressure
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No myocardial infarction within the past 6 months
- No New York Heart Association class III or IV heart disease
- No thromboembolism within the past 6 months
Other
- Chemonaive
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after study participation
- No significant traumatic injury within the past 6 weeks
- No prior allergic reaction attributed to compounds of similar chemical or biological composition to bevacizumab or other study agents
- No active infection
- No psychiatric illness or social situation that would preclude study compliance
- No serious nonhealing wound (including wounds healing by secondary intention), ulcer, or bone fracture
No CNS disease, including either of the following:
- Primary brain tumor
- Seizures not controlled with standard medical therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 8 weeks since prior monoclonal antibody therapy
- No prior bevacizumab
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- At least 4 weeks since prior major radiotherapy (e.g., chest or bone palliative radiotherapy)
Surgery
- More than 6 weeks since prior major surgical procedure or open biopsy
- More than 7 days since prior fine needle aspiration or core biopsy
- No concurrent surgery
Other
- Recovered from prior therapy
- At least 3 weeks since prior cytotoxic agents
No concurrent therapeutic anticoagulation
- Prophylactic anticoagulation of venous access devices allowed provided PT/INR or PTT criteria are met
- No concurrent chronic aspirin (greater than 325 mg/day) or nonsteroidal anti-inflammatory drugs
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational or commercial agents for the malignancy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Enmascaramiento: Ninguno (etiqueta abierta)
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Helen X. Chen, MD, NCI - Investigational Drug Branch
Publicaciones y enlaces útiles
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
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes Protectores
- 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
- Antídotos
- Complejo de vitamina B
- Fluorouracilo
- Bevacizumab
- Leucovorina
- Calcio
- Levoleucovorina
Otros números de identificación del estudio
- CDR0000320506
- CTEP-TRC-0301
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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