- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00238394
Cediranib Maleate in Treating Patients With Locally Advanced or Metastatic Liver Cancer
A Phase II Study of AZD2171 in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
PRIMARY OBJECTIVES:
I. Determine the 6-month survival of patients with locally advanced or metastatic hepatocellular carcinoma treated with AZD2171.
SECONDARY OBJECTIVES I. Determine tumor response and time to progression in patients treated with this drug.
II. Determine the toxicity of this drug in these patients. III. Correlate biological markers with response in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR. Patients experiencing disease progression within 5 years after completion of study treatment may receive additional courses of study treatment.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 20-44 patients will be accrued for this study within 22 months.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Minnesota
-
Rochester, Minnesota, Estados Unidos, 55905
- North Central Cancer Treatment Group
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Histologically confirmed hepatocellular carcinoma
- Locally advanced or metastatic disease
- Not amenable to treatment with surgery or orthotopic liver transplantation
Measurable or non-measurable disease
- Measurable disease is defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- Evidence of disease progression by imaging on serial exams or biochemical evidence of a rising alpha fetoprotein on serial testing
No history of brain metastases other than locally treatable CNS lesions (i.e., lesions treatable with surgery or radiosurgery)
- Patients with locally treatable CNS disease eligible provided they were previously treated and had no evidence of CNS progression for ≥ 4 weeks after completion of treatment
- No fibrolamellar hepatocellular carcinoma or mixed cholangiocarcinoma/hepatocellular carcinoma
- Performance status - ECOG 0-1
- Absolute neutrophil count ≥ 1,200/mm^3
- Platelet count ≥ 75,000/mm^3
- Hemoglobin ≥ 10.0 g/dL
- Bilirubin ≤ 3 times upper limit of normal (ULN)
- AST ≤ 5 times ULN
- Alkaline phosphatase ≤ 5 times ULN
- Urine protein < 1+ by urine dip stick OR proteinuria < 1 gm/24-hour collection
- QTc prolongation ≤ 500 msec
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No uncontrolled blood pressure, defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 100 mm Hg
- No significant ECG abnormality within the past 14 days
- No New York Heart Association class III or IV disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No history of allergic reaction to compounds of similar chemical or biological composition to AZD2171
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study participation
- No other uncontrolled illness
- More than 4 weeks since prior biologic therapy
- More than 4 weeks since prior and no concurrent immunotherapy
- No colony-stimulating factors during the first course of study treatment
At least 6 weeks since prior chemoembolization
- Patients must have evidence of disease progression or new metastases after prior chemoembolization
- No prior systemic chemotherapy for this cancer
- No other concurrent chemotherapy
- More than 4 weeks since prior hormonal therapy
- See Disease Characteristics
At least 6 weeks since prior radiofrequency ablation or other local ablative therapy
- Patients must have evidence of disease progression or new metastases after prior radiofrequency ablation or other local ablative therapy
- No prior external beam radiotherapy to the primary site
- No prior radiotherapy to ≥ 25% of the bone marrow
- No concurrent radiotherapy
- See Disease Characteristics
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No concurrent drugs or biologics with proarrhythmic potential
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: Treatment (cediranib maleate)
Patients receive oral AZD2171 once daily on days 1-28.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients achieving a CR receive 2 additional courses beyond CR.
Patients experiencing disease progression within 5 years after completion of study treatment may receive additional courses of study treatment.
|
Estudios correlativos
Administrado oralmente
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Survival after 6 months of treatment
Periodo de tiempo: 6 months
|
Will be estimated by the proportion of patients surviving more than 6 months.
Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
|
6 months
|
Time to disease progression
Periodo de tiempo: From registration to documentation of disease progression, assessed up to 5 years
|
Will be estimated using the method of Kaplan-Meier.
|
From registration to documentation of disease progression, assessed up to 5 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Confirmed tumor response is defined to be a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart
Periodo de tiempo: Up to 5 years
|
Up to 5 years
|
|
Laboratory measures
Periodo de tiempo: Up to 5 years
|
Descriptive statistics will be computed for the laboratory measures, including frequency and Cox proportional hazards modeling.
|
Up to 5 years
|
Colaboradores e Investigadores
Patrocinador
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
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias por sitio
- Adenocarcinoma
- Neoplasias Glandulares y Epiteliales
- Neoplasias del Sistema Digestivo
- Enfermedades del HIGADO
- Carcinoma
- Carcinoma Hepatocelular
- Neoplasias Hepaticas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Inhibidores de la proteína quinasa
- Cediranib
Otros números de identificación del estudio
- NCI-2012-01822
- U10CA025224 (Subvención/contrato del NIH de EE. UU.)
- N044J
- CDR0000446081
- NCCTG-N044J
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. .
Ensayos clínicos sobre análisis de biomarcadores de laboratorio
-
ORIOL BESTARDTerminadoTrasplante de riñón | Infección por CMVEspaña, Bélgica
-
Vanderbilt University Medical Center4DMedicalTerminado
-
Central and North West London NHS Foundation TrustBritish HIV Association (BHIVA)Aún no reclutandoInfecciones por VIH | Hepatitis B
-
Johns Hopkins UniversityReclutamiento
-
University of MiamiActivo, no reclutando
-
Hvidovre University HospitalElsassFondenTerminadoAcidosis metabólica del recién nacidoDinamarca
-
Rio de Janeiro State UniversityCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Conselho Nacional... y otros colaboradoresTerminadoEnfermedades cardiovasculares | Deficiencia de vitamina D | Condiciones relacionadas con la menopausiaBrasil