- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00107315
Bevacizumab and Capecitabine as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer
A Phase II Study of Capecitabine and Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with capecitabine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with capecitabine works as first-line therapy in treating older patients with metastatic colorectal cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
Primary
- Determine the time to disease progression in older patients with metastatic colorectal cancer treated with bevacizumab and capecitabine as first-line therapy.
Secondary
- Determine the response rate in patients treated with this regimen.
- Determine the median survival of patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral capecitabine twice daily on days 1-7. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 13-16 months.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
New York
-
Buffalo, New York, Estados Unidos, 14263-0001
- Roswell Park Cancer Institute
-
-
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 cancer
- Site of primary tumor must have been confirmed by endoscopy, radiography, or surgery
- Metastatic disease NOTE: *Patients with a history of surgically treated colorectal cancer who subsequently develop recurrent metastatic disease do not require histologic or cytologic confirmation of metastatic disease unless an interval of > 5 years has elapsed between initial primary surgery and the development of metastases
Measurable disease
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- No known curative therapy exists
- No history or evidence of CNS disease by physical exam (e.g., primary brain tumor or brain or CNS metastases)
PATIENT CHARACTERISTICS:
Age
- 70 and over
Performance status
- ECOG 0-1
Life expectancy
- More than 3 months
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- No bleeding diathesis or coagulopathy
Hepatic
- Bilirubin normal
- AST and ALT ≤ 3 times upper limit of normal (ULN)
- INR < 1.5 (unless on therapeutic anticoagulants)
- No unstable or uncompensated hepatic disease
Renal
- Creatinine < 1.2 times ULN OR
- Creatinine clearance > 60 mL/min
- No unstable or uncompensated renal disease
Cardiovascular
- No history of stroke
- No uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg on medication)
- No myocardial infarction within the past year
- No New York Heart Association class II-IV congestive heart failure
- No unstable angina
- No serious cardiac dysrhythmia requiring medication
- No other clinically significant cardiovascular disease
- No other unstable or uncompensated cardiac disease
Pulmonary
- No unstable or uncompensated respiratory disease
Other
- Fertile patients must use effective contraception
- Able to receive oral medication
- No known hypersensitivity to fluorouracil or capecitabine
- No known dihydropyrimidine dehydrogenase deficiency
- No seizures not controlled by standard medical therapy
- No serious nonhealing wound, ulcer, or bone fracture
- No other malignancy within the past 5 years except completely excised nonmelanoma skin cancer (with no evidence of recurrent disease) or carcinoma in situ of the cervix
- No other severe or uncontrolled systemic disease
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior bevacizumab
Chemotherapy
- Prior adjuvant fluorouracil and leucovorin calcium allowed provided the last treatment was administered > 6 months before the development of metastatic disease
- No prior chemotherapy for metastatic colon cancer
- No prior irinotecan or oxaliplatin
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
- More than 28 days since prior and no concurrent major surgery
- More than 28 days since prior open biopsy
- More than 7 days since prior fine needle aspiration or core biopsy
Other
- More than 4 weeks since prior and no concurrent participation in another experimental drug study
- More than 30 days since prior non-approved or investigational drugs
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Arm 1
Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral capecitabine twice daily on days 1-7
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Time to Progression
Periodo de tiempo: 1 year
|
1 year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Response Rate
Periodo de tiempo: 1 year
|
Overall Response (OR) = CR + PR.
|
1 year
|
Median Survival
Periodo de tiempo: 1 year
|
1 year
|
|
Toxicity
Periodo de tiempo: 1 year
|
Number of participants with an adverse event. Please refer to the adverse event reporting for more detail. |
1 year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Marwan Fakih, MD, Roswell Park Cancer Institute
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (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 antineoplásicos inmunológicos
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Capecitabina
- Bevacizumab
Otros números de identificación del estudio
- I 22204
- RPCI-I-22204
- GENENTECH-RPCI-I-22204
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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