- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00217672
Docetaxel With Bevacizumab as First-Line Therapy in Treating Women With Stage IV Breast Cancer
A Randomized Phase II Trial of Docetaxel With or Without Bevacizumab as First-Line Therapy for Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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 tumor cells by stopping blood flow to the tumor. It is not yet known whether giving docetaxel together with bevacizumab is more effective than docetaxel alone in treating breast cancer.
PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with bevacizumab works compared to docetaxel alone as first-line therapy in treating women with stage IV breast cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria
- Female 18 and over
- Histologically or cytologically confirmed adenocarcinoma of the breast at first diagnosis
- Stage IV disease, with at least one measurable lesion according to the RECIST criteria.
- HER2-negative disease, by fluorescence in situ hybridization
- ECOG performance status 0-1
- Life expectancy of at least 24 weeks
- No prior chemotherapy for metastatic breast cancer (prior endocrine therapy is permitted).
- Prior adjuvant chemotherapy is permitted. If patients received a taxane in the adjuvant setting, at least 12 months must have elapsed since the completion of adjuvant therapy.
- At least 4 weeks since prior surgery, radiotherapy, endocrine therapy, or experimental drug therapy, with complete recovery from the effects of these interventions
- If female of childbearing potential, pregnancy test is negative and willing to use effective contraception while on treatment for at least 3 months thereafter.
- Patient is accessible and willing to comply with treatment and follow-up.
- Patient is willing to provide written informed consent prior to the performance of any study-related procedures.
Required laboratory values
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9.0 g/dL
- Creatinine ≤ 2.0 mg/dL
- Total bilirubin < 1.0 x upper limit of normal (ULN) (patients with documents Gilbert's syndrome are eligible).
- Alkaline phosphatase (AP) normal AND Angiotensin Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) ≤ 2.5 times upper limit of normal (ULN) or AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN or AP ≤ 5 times ULN AND AST or ALT normal.
Exclusion Criteria
- Prior chemotherapy for metastatic breast cancer
- Prior treatment with an anti-angiogenic agent
- Concurrent therapy with any other non-protocol anti-cancer therapy
- Current or prior history of central nervous system or brain metastases
- Presence of neuropathy > grade 2 (NCI- Common Toxicity Criteria (CTC) version 3.0) at baseline
- Presence of any non-healing wound, fracture, or ulcer, or the presence of clinically significant (> grade 2) peripheral vascular disease
- History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix
- Clinically significant cardiovascular disease (e.g., uncontrolled hypertension [BP > 150/100]), myocardial infarction or stroke within the past 6 months, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
- Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning therapy
- Active, uncontrolled infection requiring parenteral antimicrobials
- The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of the drugs in this protocol or place the subject at undue risk for treatment complications.
- Inability to comply with the study protocol or follow-up procedures
- Pregnancy or lactation
- A history of a severe hypersensitivity reaction to Bevacizumab, or Docetaxel or other drugs formulated with polysorbate 80.
- Evidence of bleeding diathesis or coagulopathy
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to beginning therapy, or anticipation of the need for a major surgical procedure during the course of the study; minor surgical procedure, fine needle aspiration or core biopsy within 7 days prior to beginning therapy
- Proteinuria at baseline or clinically significant impairment of renal function. Subjects unexpectedly discovered to have > 1+ proteinuria at baseline should undergo a 24 hour urine collection, which must be an adequate collection and must demonstrate <1 gm of protein/24 hour to allow participation in the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Bevacizumab + Docetaxel
docetaxel: 75 mg/m2 IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent. Bevacizumab: 15 mg/kg IV every 3 weeks. Subjects continue on study until disease progression, unacceptable toxicity, or withdrawal of patient consent. |
Patients receive bevacizumab 15 mg/kg intravenously (I.V.) every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal.
docetaxel: 75 mg/m2 IV q3 weeks.
Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
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Comparador activo: docetaxel
docetaxel: 75 mg/m2 IV q3 weeks.
Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
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docetaxel: 75 mg/m2 IV q3 weeks.
Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Antitumor Activity Based on Time to Tumor Progression (TTP).
Periodo de tiempo: From randomization until tumor progression
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From randomization until tumor progression
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Comparison of Response Rates, Duration of Response, and Overall Survival
Periodo de tiempo: Time of death, up to 3 years
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Time of death, up to 3 years
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Comparison of Safety and Toxicity
Periodo de tiempo: When adverse events occur, up to 30 days after last dose for each subject, up to 3 years from start of study
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Evaluated using adverse event (AE) information.
Detailed AE information is provided in the AE section.
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When adverse events occur, up to 30 days after last dose for each subject, up to 3 years from start of study
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sara Hurvitz, MD, Jonsson Comprehensive Cancer Center
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 de la piel
- Neoplasias
- Neoplasias por sitio
- Enfermedades de los senos
- Neoplasias de mama
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes antineoplásicos inmunológicos
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Docetaxel
- Bevacizumab
Otros números de identificación del estudio
- CDR0000442877
- UCLA-0501049-01 (Otro identificador: UCLA)
- TORI-B-01 (Otro identificador: UCLA)
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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