- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00475085
Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial
RATIONALE: Antiemetic drugs, such as granisetron, dexamethasone, prochlorperazine, aprepitant, and palonosetron, may help lessen or prevent nausea. It is not yet known which combination of antiemetic drugs is more effective in preventing nausea caused by chemotherapy.
PURPOSE: This randomized phase III trial is comparing different combinations of granisetron, dexamethasone, prochlorperazine, aprepitant, and palonosetron to see how well they work in preventing nausea in patients undergoing chemotherapy for breast cancer.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
OBJECTIVES:
Primary
- Compare the efficacy of palonosetron hydrochloride and dexamethasone followed by prochlorperazine with vs without dexamethasone in preventing delayed nausea in women with chemotherapy-naive breast cancer. (Arms I and IV)
- Determine if palonosetron hydrochloride is more effective than granisetron hydrochloride in controlling treatment-related delayed nausea in these patients. (Arms I and II)
- Determine if the currently recommended antiemetic guideline of aprepitant combined with palonosetron hydrochloride and dexamethasone is the most effective antiemetic regimen for controlling treatment-related delayed nausea in these patients. (Arms III and IV)
Secondary
- Determine if the addition of dexamethasone to prochlorperazine is more effective than the same regimen without dexamethasone for reducing interference with functioning caused by chemotherapy-induced nausea and vomiting in these patients. (Arms I and IV)
- Determine if palonosetron hydrochloride is more effective than granisetron hydrochloride for reducing interference with functioning caused by chemotherapy-induced nausea and vomiting in these patients. (Arms I and II)
- Determine if the currently recommended antiemetic guideline of aprepitant combined with palonosetron hydrochloride and dexamethasone is the most effective antiemetic regimen for reducing interference with functioning due to chemotherapy-induced nausea and vomiting in these patients. (Arms III and IV)
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to CCOP center and gender. Patients are randomized to 1 of 4 treatment arms. Patients receive study treatment approximately 30 minutes before their scheduled first chemotherapy treatment.
- Arm I: Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
- Arm II: Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
- Arm III: Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.
- Arm IV: Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.
Quality of life is assessed at baseline and on day 4. Nausea and vomiting, fatigue, sleep quality, exercise, and the need for rescue medication (metoclopramide) are assessed on days 1-4.
PROJECTED ACCRUAL: A total of 890 patients will be accrued for this study.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Mobile, Alabama, Estados Unidos, 36695
- MBCCOP - Gulf Coast
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Illinois
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Decatur, Illinois, Estados Unidos, 62526
- CCOP - Central Illinois
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Kansas
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Wichita, Kansas, Estados Unidos, 67214-3882
- CCOP - Wichita
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Michigan
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Grand Rapids, Michigan, Estados Unidos, 49503
- CCOP - Grand Rapids
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Kalamazoo, Michigan, Estados Unidos, 49007-3731
- CCOP - Kalamazoo
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Minnesota
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St. Louis Park, Minnesota, Estados Unidos, 55416
- CCOP - Metro-Minnesota
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Missouri
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Kansas City, Missouri, Estados Unidos, 64131
- CCOP - Kansas City
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89106
- CCOP - Nevada Cancer Research Foundation
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New York
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East Syracuse, New York, Estados Unidos, 13057
- CCOP - Hematology-Oncology Associates of Central New York
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Manhassett, New York, Estados Unidos, 11030
- CCOP - North Shore University Hospital
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North Carolina
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Goldsboro, North Carolina, Estados Unidos, 27534-9479
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Columbus, Ohio, Estados Unidos, 43215
- CCOP - Columbus
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Dayton, Ohio, Estados Unidos, 45429
- CCOP - Dayton
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South Carolina
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Greenville, South Carolina, Estados Unidos, 29615
- CCOP - Greenville
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Washington
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Tacoma, Washington, Estados Unidos, 98405-0986
- CCOP - Northwest
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Wisconsin
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Marshfield, Wisconsin, Estados Unidos, 54449
- CCOP - Marshfield Clinic Research Foundation
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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:
- Have a diagnosis of cancer and be chemotherapy naive.
- Must be scheduled to receive a chemotherapy treatment containing doxorubicin hydrochloride, epirubicin hydrochloride, cisplatin, carboplatin, or oxaliplatin (any dose or schedule) without concurrent radiotherapy or interferon treatment
- Chemotherapy may be for adjuvant, neoadjuvant, curative or palliative intent.
- Dose-dense regimens (e.g. chemotherapy with doxorubicin or epirubicin given every two weeks)are allowed.
- For the purposes of this study, Day 1 of chemotherapy will be defined as the day of administration of cisplatin, carboplatin, oxaliplatin, doxorubicin or epirubicin.
- Regimens with multiple-day doses of doxorubicin, epirubicin, cisplatin, carboplatin, oxaliplatin, dacarbazine, hexamethylmelamine, nitrosoureas, or streptozocin are not allowed. Chemotherapy agents, other than those listed above, may be given orally, intravenously, or by continuous infusion on one or multiple days.
- Able to understand English
Exclusion criteria:
- No symptomatic brain metastases
- No concurrent or impending bowel obstruction
- Regimens containing liposomal doxorubicin or cisplatin are not allowed.
- No concurrent pimozide, terfenadine, astemizole, or cisapride
- No concurrent doxorubicin hydrochloride liposome or cisplatin
- No concurrent multiple-day doses of dacarbazine, altretamine, nitrosoureas, streptozocin, cisplatin, carboplatin, or oxaliplatin
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Arm I
Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
|
Administrado oralmente
Administrado por vía oral o IV
Otros nombres:
Given orally or IV
Otros nombres:
Given orally or IV
Otros nombres:
|
Experimental: Arm II
Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
|
Administrado oralmente
Administrado por vía oral o IV
Otros nombres:
Given orally or IV
Otros nombres:
Given orally or IV
Otros nombres:
|
Comparador activo: Arm III
Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.
|
Administrado oralmente
Administrado por vía oral o IV
Otros nombres:
Given orally or IV
Otros nombres:
Given orally or IV
Otros nombres:
|
Experimental: Arm IV
Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.
|
Administrado oralmente
Administrado por vía oral o IV
Otros nombres:
Given orally or IV
Otros nombres:
Given orally or IV
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Home Record: Severity of Delayed Nausea
Periodo de tiempo: average of day 1 afternoon, evening and night, and all of days 2 and 3
|
1=not at all nauseated to 7=extremely nauseated, therefore higher values are worse
|
average of day 1 afternoon, evening and night, and all of days 2 and 3
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Joseph A. Roscoe, PhD, James P. Wilmot Cancer Center
Publicaciones y enlaces útiles
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
Palabras clave
Términos MeSH relevantes adicionales
- Signos y Síntomas Digestivos
- Náuseas
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Depresores del sistema nervioso central
- Agentes Autonómicos
- Agentes del sistema nervioso periférico
- Agentes antiinflamatorios
- Agentes antineoplásicos
- Antieméticos
- Agentes Gastrointestinales
- Glucocorticoides
- Hormonas
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Agentes Antineoplásicos Hormonales
- Agentes antipsicóticos
- Agentes tranquilizantes
- Drogas psicotropicas
- Agentes de serotonina
- Agentes de dopamina
- Antagonistas de serotonina
- Antagonistas de la dopamina
- Antagonistas del receptor de serotonina 5-HT3
- Antagonistas del receptor de neuroquinina-1
- Dexametasona
- Palonosetrón
- Granisetrón
- Aprepitant
- Proclorperazina
Otros números de identificación del estudio
- CDR0000544841
- U10CA037420 (Subvención/contrato del NIH de EE. UU.)
- URCC-U1105 (Otro identificador: University of Rochester)
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