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A Phase II Study of Cisplatin Plus Etoposide (PE) Plus Bevacizumab (NSC #704865) for Previously Untreated Extensive Stage Small Cell Lung Cancer

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

cisplatin

+ etoposide

+ bevacizumab

MedicamentoBiológicoOtro
Quiénes están siendo reclutados

Carcinoma broncogénico+6

+ Neoplasias bronquiales

+ Enfermedades del pulmón

A partir de 18 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 2
Intervencional
Inicio del estudio: enero de 2006
Ver detalles del protocolo

Resumen

Patrocinador PrincipalNational Cancer Institute (NCI)
Última actualización: 14 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de enero de 2006

Fecha en la que se inscribió al primer participante.

PRIMARY OBJECTIVES: I. To evaluate the combination of PE plus concurrent and sequential bevacizumab with respect to six month progression free survival in patients with previously untreated SCLC. II. To evaluate the combination of PE plus concurrent and sequential bevacizumab with respect to survival and response rate. III. To evaluate toxicity in patients with extensive small cell lung cancer, treated with the combination of PE plus concurrent and sequential bevacizumab who have received no prior systemic chemotherapy. SECONDARY OBJECTIVES: I. To determine if pre-treatment levels of plasma VEGF predict response to chemotherapy with Etoposide-Cisplatin plus concurrent + sequential bevacizumab. II. To determine if pre-treatment plasma VEGF is predictive of progression free survival and overall survival in advanced SCLC. III. To determine whether elevated plasma levels of endothelial cell-specific proteins (VCAM, E-selectin), reflective of chemotherapy or bevacizumab induced endothelial damage, are useful markers in assessing response to Etoposide/Cisplatin plus concurrent + sequential bevacizumab. IV. To determine whether pre- and post-treatment plasma levels of basic fibroblast growth factor (bFGF) is predictive of progression free survival and overall survival or predictive of response to therapy. OUTLINE: This is a multicenter study. Chemotherapy: Patients receive cisplatin IV over 30-60 minutes on day 1 and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Bevacizumab therapy: Beginning concurrently with chemotherapy, patients receive bevacizumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 17 courses (1 year) in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks for up to 3 years from study entry.

Título OficialA Phase II Study of Cisplatin Plus Etoposide (PE) Plus Bevacizumab (NSC #704865) for Previously Untreated Extensive Stage Small Cell Lung Cancer 
NCT00079040
Patrocinador PrincipalNational Cancer Institute (NCI)
Última actualización: 14 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 65 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Carcinoma broncogénicoNeoplasias bronquialesEnfermedades del pulmónNeoplasmas PulmonaresNeoplasiasNeoplasias por SitioNeoplasias del tracto respiratorioEnfermedades del Tracto RespiratorioNeoplasias torácicas

Criterios

Inclusion Criteria: * Histologic (or cytologic) proof of small cell lung cancer must be confirmed * Patients must be clinically staged as extensive disease * Patients must have measurable disease as defined by RECIST criteria; baseline scans/evaluation used to document measurable disease must be done within 4 weeks prior to registration; patients with measurable disease only or with both measurable and non-measurable disease are eligible * Patients must have ECOG performance status of 0, 1, or 2 * Patients may not have had prior chemotherapy, immunotherapy, or biological therapy for lung cancer; previously irradiated lesions must not be the only site of measurable disease * ANC \> 1500/mm\^3 * Platelets \>= 100,000/mm\^3 * Creatinine =\< 1.5 mg * Total bilirubin =\< 1.5 mg * Pregnant or breastfeeding women are excluded from the study because the agents used in this study may be teratogenic to a fetus or child and there is no information on the excretion of the agents or their metabolites into breast milk; all females of childbearing potential must have a blood test or urine study within 2 weeks, prior to registration to rule out pregnancy * Women of childbearing potential and sexually active males are strongly advised to use an effective method of contraception * Patients must be disease-free for \> 5 years if they have a history of prior malignancies (except for cured basal or squamous cell skin cancers, or carcinoma in situ of the cervix) * Patients must be considered on psychosocial grounds to be willing and able to comply with the requirements of treatment and follow-up * Patients must not have CNS metastases; a head CT is required within 4 weeks prior to study entry for evaluation (MRIs are also acceptable) * Urine dipstick for proteinuria of less than 1+ is required within 7 days prior to study entry; if urine dipstick is \>= 1+ then a 24 hour urine for protein must demonstrate =\< 1 gm of protein in 24 hours to allow participation in the study; NOTE: Urinalysis is also acceptable * Patients must have INR =\< 1.5 and a PTT no greater than the institutional upper limit of normal within 1 week prior to registration * Patients must not have ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Patients must not have history of thrombotic or hemorrhagic disorders; patients must not have recently (within 6 months of registration) experienced arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina, or myocardial infarction (MI); patients must also not have clinically significant peripheral artery disease * Patients with history of hypertension must be well-controlled (=\< 150/85) on a stable regimen of anti-hypertensive therapy * Patients must not be receiving chronic daily treatment with aspirin (\> 325 mg/day) or nonsteroidal anti-inflammatory agents known to inhibit platelet function; treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and/or cilostazol (Pletal) is also not allowed * Patients must not have serious non-healing wound, ulcer, or bone fracture, or major surgical procedure within 28 days prior to starting treatment; patients must not have had minor surgery or needle biopsies within 7 days of treatment * Patients must not be on therapeutic anticoagulation * Patients with a history of gross hemoptysis (defined as bright red blood of a 1/2 teaspoon or more) will be excluded from this trial * Patients must have had no prior radiation therapy to the site of evaluable disease

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

Un solo grupo de intervención está designado en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Chemotherapy: Patients receive cisplatin IV over 30-60 minutes on day 1 and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Bevacizumab therapy: Beginning concurrently with chemotherapy, patients receive bevacizumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 17 courses (1 year) in the absence of disease progression or unacceptable toxicity.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Suspendido

Eastern Cooperative Oncology Group

Boston, United StatesVer ubicación
Completado1 Centros de Estudio