Nab-paclitaxel en el tratamiento de pacientes mayores con cáncer de mama metastásico o localmente avanzado
Eficacia y tolerabilidad de paclitaxel unido a nanopartículas de albúmina (Abraxane) en pacientes de 65 años o más con cáncer de mama metastásico o localmente avanzado
This phase II trial studies the side effects of nab-paclitaxel in treating older patients with breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or to other places in the body (metastatic). Drugs used in chemotherapy, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
PRIMARY OBJECTIVE:
I. To evaluate the tolerability (grade 2-5 toxicity, neuropathy grade 2 or higher, need for dose reductions, or delays) of weekly nab-paclitaxel in older adults with locally advanced or metastatic breast cancer.
SECONDARY OBJECTIVES:
I. To evaluate the efficacy (response and time to progression) of weekly nab-paclitaxel in older adults with locally advanced or metastatic breast cancer using a stratification factor based on patient age (at least 5 patients age 75 years or older and no more than 15 patients age 65-70 years).
II. To explore predictors of the need for dose reduction, dose delays, or grade 2-5 toxicity and neuropathy grade 2 or higher based on a cancer-specific geriatric assessment.
OUTLINE:
Patients receive nab-paclitaxel intravenously (IV) over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Duarte, California, Estados Unidos, 91010
- City of Hope medical
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Lancaster, California, Estados Unidos, 93534
- City of Hope Antelope Valley
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South Pasadena, California, Estados Unidos, 91030
- City of Hope South Pasadena
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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- Ohio State University Comprehensive Cancer Center
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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:
- Locally advanced or metastatic breast cancer
- Any estrogen receptor (ER), progesterone receptor (PR), or human epidermal growth factor receptor 2 (Her2neu) status as long as the patient will receive nab-paclitaxel alone
- First or second line chemotherapy treatment for metastatic disease
- Karnofsky performance status (KPS) >= 70%
- Resolution of grade >= 2 toxicity from prior therapy (other than alopecia)
- Peripheral neuropathy =< grade 1
- Absolute neutrophil count >= 1,500/mm^3
- Platelets >= 100,000 cells/mm^3
- Hemoglobin (Hb) >= 9.0 g/dl
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional upper limit of normal
- Alkaline phosphatase =< 2.5 x upper limit of normal unless bone metastasis are present in the absence of liver metastases
- Bilirubin =< 1.5 mg/dl
- Creatinine clearance (calculated or 24 hour) >= 30 ml/min
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Patients may not be receiving any other investigational agents
- Untreated central nervous system (CNS) metastases or symptomatic CNS metastases requiring escalating doses of corticosteroids
- Known history of allergic reactions to paclitaxel
- Presence of any serious or uncontrolled infection
- Receipt of a taxane for adjuvant therapy or metastatic disease in the last 12 months
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 (nab-paclitaxel)
Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Correlative studies Ancillary studies Given IV
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percent of Participants With Grade 2-5 Toxicity Using National Cancer Institute Common Toxicity Criteria Version 4.0
Periodo de tiempo: During and after treatment, up to 2.5 years
|
Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for grade 2 or higher toxicities attributed to treatment. |
During and after treatment, up to 2.5 years
|
|
Percent of Participants With Grade 3 or Higher Toxicities Attributable to Treatment
Periodo de tiempo: On treatment, 28 days per cycle up to 30 months
|
Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for grade 3 or higher toxicities attributed to treatment. |
On treatment, 28 days per cycle up to 30 months
|
|
Rate of Participants With a Dose Reduction
Periodo de tiempo: On treatment, up to 30 months
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Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for dose reduction. |
On treatment, up to 30 months
|
|
Rate of Participants Requiring Dose Holds
Periodo de tiempo: While on treatment, up to 30 months
|
Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for dose reduction. |
While on treatment, up to 30 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Response Determined by Response Evaluation Criteria in Solid Tumors
Periodo de tiempo: Up to 2.5 years
|
Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for objective response rate (complete response [CR] + partial response [PR]). RECIST: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. Additionally, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study |
Up to 2.5 years
|
|
Median Progression Free Survival (PFS)
Periodo de tiempo: From the date treatment begins until the first date on which recurrence, progression, or death due to any cause, assessed for about 1.5 years
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PFS will be estimated using the product limit method of Kaplan and Meier. |
From the date treatment begins until the first date on which recurrence, progression, or death due to any cause, assessed for about 1.5 years
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Cancer-specific Geriatric (CARG) Assessment
Periodo de tiempo: CARG measured prior to treatment, toxicities and dose reduction measured up to 30 months
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General linear models and descriptive methods will be used to explore factors as identified by a CARG assessment that may be predictive of toxicity (grade 3 or higher adverse events) or dose reduction. The cancer specific geriatric assessment score includes an evaluation of functional status, co-morbidity, cognition, psychological stats, social functioning and support, and nutritional status. It assesses a patient's age, gender, height, weight, cancer type, dosage, number of chemotherapy agents, hemoglobin, hearing, number of falls in past 6 months, able to take own medicine, whether walking is limited, have physical or emotional problems interfered with social activities and serum creatinine. Scores can range from 0 to to 1, with a higher score indicating higher risk of chemotherapy toxicity. Scores from 0 to 5 are considered low risk, 6 to 9 are considered intermediate risk, and 10 to 19 are considered high risk. |
CARG measured prior to treatment, toxicities and dose reduction measured up to 30 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mina Sedrak, City of Hope Medical Center
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimado)
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
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades de la piel
- Enfermedades de los senos
- Enfermedades de la piel y del tejido conectivo
- Neoplasias de mama
- Aminoácidos, péptidos y proteínas
- Proteínas
- Químicos orgánicos
- Hidrocarburos
- Cicloparafinas
- Hidrocarburos, alicíclicos
- Hidrocarburos, cíclico
- Terpenos
- Taxaides
- Ciclodecanos
- Diterpenos
- Economía y organizaciones de la atención médica
- Albúmina
- Paclitaxel
- Ciencias económicas
- Paclitaxel unido a albúmina
- Paclitaxel de 130 nm en albúmina
- Impuestos
Otros números de identificación del estudio
- 11139
- P30CA033572 (Subvención/contrato del NIH de EE. UU.)
- 11139 (Otro identificador: City of Hope Comprehensive Cancer Center)
- NCI-2011-03295 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- 118196
- 124494
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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