A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) in Patients With Advanced or Metastatic Liver Cancer
7 de mayo de 2014 actualizado por: Hoffmann-La Roche
A Single-arm, Open-label Study of Avastin Plus Xeloda on Objective Treatment Response in Patients With Advanced or Metastatic Liver Cancer Who Have Had no Previous Cytotoxic Chemotherapy
This study will evaluate the efficacy and safety of oral Xeloda (capecitabine) plus intravenous Avastin (bevacizumab) in patients with advanced or metastatic liver cancer.
The anticipated time on study treatment is 3-12 months.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
45
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- adult patients >=18 years of age;
- advanced or metastatic liver cancer;
- >=1 measurable lesion.
Exclusion Criteria:
- current radiotherapy, chemotherapy, or other experimental therapies;
- prior cytotoxic chemotherapy;
- major surgery, open biopsy, or traumatic injury within 28 days of study entry;
- history of a malignancy during the last 5 years, other than cutaneous basal cell cancer or in situ cervical cancer.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Avastin + Xeloda
|
7.5mg/kg iv on day 1 of each 3 week cycle.
1600mg/m2/day po in 2 divided doses, on days 1 to 14 of each 3 week cycle.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants With Objective Response (OR)
Periodo de tiempo: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
|
Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).
Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response.
The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported.
CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels.
No new lesions.
PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions.
The short axis was used in the sum for target lesions.
Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits.
No new lesions.
|
Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants With Disease Control
Periodo de tiempo: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
|
The percentage of participants with disease control was based on assessment of confirmed CR, PR, or stable disease (SD) according to RECIST criteria.
Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response.
The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported.
CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels.
No new lesions.
PR was defined as ≥ 30 % decrease under baseline of the sum of diameters of all target lesions.
The short axis was used in the sum for target lesions.
Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits.
No new lesions.
SD was defined as not qualifying for PR or progressive disease.
|
Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
|
|
Time to Disease Progression - Percentage of Participants With an Event
Periodo de tiempo: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
|
Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death.
Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment.
|
Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
|
|
Time to Disease Progression
Periodo de tiempo: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
|
Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death.
Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of their tumor assessment.
|
Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
|
|
Time to Disease Progression - Percentage of Participants Progression-free at 12 Months
Periodo de tiempo: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
|
Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death.
Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment.
|
Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
|
|
Overall Survival - Percentage of Participants With an Event
Periodo de tiempo: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
|
Overall Survival was defined as the time in months from randomization to date of death due to any cause.
Participants without an event were censored the last time they were known to be alive.
|
Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
|
|
Overall Survival
Periodo de tiempo: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
|
Overall Survival was defined as the time in months from randomization to date of death due to any cause.
Participants without an event were censored the last time they were known to be alive.
Median Overall Survival was estimated using the Kaplan-Meier method.
|
Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
|
|
Overall Survival - Percentage of Participants Event Free at 12 Months
Periodo de tiempo: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
|
Overall Survival was defined as the time in months from randomization to date of death due to any cause.
Participants without an event were censored the last time they were known to be alive.
|
Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de mayo de 2005
Finalización primaria (Actual)
1 de marzo de 2008
Finalización del estudio (Actual)
1 de marzo de 2008
Fechas de registro del estudio
Enviado por primera vez
3 de diciembre de 2013
Primero enviado que cumplió con los criterios de control de calidad
11 de diciembre de 2013
Publicado por primera vez (Estimar)
17 de diciembre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
6 de junio de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
7 de mayo de 2014
Última verificación
1 de mayo de 2014
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Neoplasias
- Neoplasias por sitio
- Neoplasias del Sistema Digestivo
- Enfermedades del HIGADO
- Neoplasias Hepaticas
- 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
- ML18469
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. .