- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00066677
Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
Phase II and Coagulation Study of rhuMAb-VEGF With or Without Docetaxel in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining bevacizumab with docetaxel may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying bevacizumab and docetaxel to see how well they work compared to bevacizumab alone in treating patients with metastatic pancreatic cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- Determine the progression-free survival of patients with previously treated metastatic pancreatic adenocarcinoma treated with bevacizumab with or without docetaxel.
- Determine the objective response rate and overall survival of patients treated with these regimens.
- Determine the incidence of thromboembolic events in patients treated with these regimens.
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and docetaxel IV over 1 hour on days 1, 8, and 15.
- Arm II: Patients receive bevacizumab as in arm I. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 46 patients (23 per treatment arm) will be accrued for this study.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19111-2497
- Fox Chase Cancer Center - Philadelphia
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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 adenocarcinoma of the pancreas
- Metastatic disease
Unidimensionally measurable disease outside of the pancreas
- At least 1 lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- Must have received 1, and only 1, prior gemcitabine-containing regimen for metastatic disease unless disease has recurred within 6 months after treatment with neoadjuvant or adjuvant gemcitabine-containing therapy
- No brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9.0 g/dL (transfusion allowed)
- No bleeding diathesis or coagulopathy
Hepatic
- Bilirubin no greater than upper limit of normal (ULN)
- AST and ALT no greater than 1.5 times ULN
- INR no greater than ULN
- PTT no greater than ULN
Renal
- Creatinine no greater than 2.0 mg/dL
- No clinically significant renal impairment
- Urine protein:creatinine ratio ≥ 1.0
Cardiovascular
- No prior myocardial infarction
- No prior stroke
- No clinically significant cardiovascular disease
- No uncontrolled hypertension (i.e., blood pressure greater than 160/110 mm Hg on medication)
- No unstable angina
- No New York Heart Association class II-IV congestive heart failure
- No serious cardiac dysrhythmia requiring medication
- No peripheral vascular disease
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history or evidence of CNS disease (e.g, primary brain tumor or seizures not controlled with standard medical therapy)
- No other medical condition that would preclude study participation
- No psychiatric condition that would preclude study participation
- No other prior or concurrent malignancy that would preclude study participation
- No significant traumatic injury within the past 28 days
- No serious, nonhealing wound, ulcer, or bone fracture
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent prophylactic granulocyte or platelet growth factors
Chemotherapy
- See Disease Characteristics
- More than 4 weeks since prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- At least 4 weeks since prior radiotherapy
Surgery
- More than 7 days since prior fine needle aspirations or core biopsies
- More than 28 days since prior surgery (except closed biopsy or access port placement)
- More than 28 days since prior open biopsy
- No concurrent surgery
Other
- More than 4 weeks since prior experimental drug study participation
- More than 4 weeks since prior investigational drugs
- No other concurrent experimental drug study participation
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: rhuMAB-VEGF
bevacizumab 10 mg/kg by intravenous infusion over 30-90 minutes once every 2 weeks until disease progression, unacceptable toxicity or patient preference.
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Experimental: rhuMAB-VEGF and Docetaxel
rhuMAB-VEGF,bevacizumab: 10 mg/kg by intravenous infusion over 30-90 minutes once every 2 weeks docetaxel, Taxotere: 35 mg/m2 given intravenously over 1 hour on days 1, 8, and 15 of each 28 day cycle.
Treatment continued until evidence of disease progression, unacceptable toxicity, or patient preference.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Progression-free Survival
Periodo de tiempo: 4 months
|
4 months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Objective Response Rate
Periodo de tiempo: 56 days
|
56 days
|
Overall Survival
Periodo de tiempo: From date of registration until the date of death, assessed up to 5 years
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From date of registration until the date of death, assessed up to 5 years
|
Number of Participants With Thromboembolic Events
Periodo de tiempo: 93 days
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93 days
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Steven J. Cohen, MD, Fox Chase Cancer Center
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
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 (Actual)
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
- Enfermedades del sistema endocrino
- Neoplasias del Sistema Digestivo
- Neoplasias de glándulas endocrinas
- Enfermedades pancreáticas
- Neoplasias pancreáticas
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Docetaxel
Otros números de identificación del estudio
- CDR0000316454
- P30CA006927 (Subvención/contrato del NIH de EE. UU.)
- FCCC-03003
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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