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- Ensayo clínico NCT01160731
Panobinostat, Etoposide, and Cisplatin as First-Line Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
A Phase I Dose Finding Study of the Pan-DAC Inhibitor Panobinostat (LBH589) in Combination With Etoposide and Cisplatin in the First Line Treatment of Extensive-Stage Small Cell Lung Cancer - An ICORG In-House Study
RATIONALE: Panobinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as etoposide and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving panobinostat together with etoposide and cisplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of panobinostat when given together with etoposide and cisplatin as first-line therapy in treating patients with extensive-stage small cell lung cancer.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
OBJECTIVES:
Primary
- To determine the maximum-tolerated dose, the recommended dose, and the activity of panobinostat when given in combination with etoposide and cisplatin to patients with extensive-stage small cell lung cancer.
Secondary
- To estimate the time-to-progression, the duration of response, and disease stabilization in these patients.
- To estimate the overall survival of these patients.
- To determine the pharmacokinetic profile of panobinostat in combination with etoposide and cisplatin.
- To assess the overall safety profile of panobinostat in these patients.
- To determine the adverse events in these patients treated with this regimen.
- To assess the quality of life of these patients.
OUTLINE: This is a multicenter, dose-escalation study of panobinostat.
Patients receive chemotherapy comprising cisplatin IV on day 1, etoposide IV on days 1-3, and panobinostat IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then periodically during study treatment and follow up, using questionnaire EQ-5D (Euro QoL).
Blood samples may be collected at baseline and periodically during and after study treatment for pharmacokinetic assessment and biomarker translational studies.
After completion of study treatment, patients are followed up at 4 weeks and then every 3 months.
Tipo de estudio
Fase
- Fase 1
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell lung cancer
- Extensive-stage disease
- Measurable disease according to RECIST criteria
- No symptomatic brain metastasis or meningeal tumors
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 6 months
- Absolute neutrophil count > 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10.0 g/dL
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR 24-hour creatinine clearance ≥ to 60 mL/min
- Magnesium, potassium, and phosphorus ≥ the lower limit of normal OR correctable with supplements prior to study treatment
- AST/ALT ≤ 2.5 x ULN (≤ 5.0 x ULN if hepatic metastases are present)
- Serum bilirubin ≤ 1.5 x ULN
- Alkaline phosphatase ≤ 2.5 x ULN OR liver fraction ≤ 2.5 x ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double contraception (at least 1 barrier method) during and for at least 30 days after completion of study treatment
No impaired cardiac function, including any one of the following:
- LVEF < 45% as determined by ECHO
- Complete left bundle branch block, obligate use of a cardiac pacemaker, congenital long QT syndrome, history or presence of atrial or ventricular tachyarrhythmias, clinically significant resting bradycardia (< 50 beats per minute), QTcF > 480 msec on screening ECG, or right bundle branch block and left anterior hemiblock (bifascicular block)
- Uncontrolled angina pectoris or acute myocardial infarction within the past 3 months
- Other clinically significant heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
- No history of HIV or AIDS-related illness
- No acute or chronic liver or renal disease
No other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol, including any of the following:
- Uncontrolled diabetes
- Chronic obstructive or chronic restrictive pulmonary disease
- Active or uncontrolled infection
- No known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to panobinostat, cisplatin, or etoposide
- No hearing impairment that would be a contraindication to the use of cisplatin
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy
- No investigational drug or experimental medications or treatments within the past 30 days or 5 half-lives, whichever is longer
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: Cisplatin, Etoposide & Panobinostat
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
---|
Maximum-tolerated dose (MTD) and recommended dose (RD)
|
Response rates and toxicity at MTD and RD
|
Objective response rate according to RECIST criteria
|
Medidas de resultado secundarias
Medida de resultado |
---|
Eventos adversos
|
Time to progression according to RECIST criteria
|
Duration of response or disease stabilization according to RECIST criteria
|
Overall survival according to RECIST criteria
|
Effect of the combination regimen on drug pharmacokinetics
|
Quality of life evaluated by EQ-5D (Euro QoL)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Paul Donnellan, Galway University Hospital
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
- Enfermedades de las vías respiratorias
- Neoplasias
- Enfermedades pulmonares
- Neoplasias por sitio
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Neoplasias Pulmonares
- Carcinoma de pulmón de células pequeñas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Agentes antineoplásicos, fitogénicos
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Inhibidores de histona desacetilasa
- Etopósido
- Fosfato de etopósido
- Cisplatino
- Panobinostat
Otros números de identificación del estudio
- 07-09 ICORG
- ICORG-07-09
- EUDRACT-2008-003634-21
- EU-21047
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