- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00369551
Bevacizumab, Paclitaxel, Carboplatin, and Radiation Therapy to the Chest in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer
A Safety and Feasibility Study of Bevacizumab With Paclitaxel, Carboplatin and Chest Radiotherapy in Patients With Locally Advanced Non-Small Lung Cancer
Visão geral do estudo
Status
Condições
Descrição detalhada
PRIMARY OBJECTIVES:
I. Assess the feasibility of administering bevacizumab, paclitaxel, carboplatin, and chest radiotherapy in patients with locally advanced non-small cell lung cancer.
II. Characterize the toxicity of this treatment regimen. III. Assess the clinical response to this treatment regimen. IV. Correlate circulating levels of angiopoietin-2 and vascular endothelial growth factor receptor-2 with clinical response to this treatment regimen.
OUTLINE: This is an open-label, multicenter study.Induction therapy.
Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, 36, and 43 and bevacizumab IV over 30-90 minutes on days 1, 15, 29, and 43. Patients also undergo chest radiotherapy 5 days a week for 7 weeks beginning on day 1.
Consolidation therapy: Beginning 4-5 weeks after completion chemoradiotherapy, patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 1 hour followed by bevacizumab IV over 30 minutes. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
After study completion, patients are followed periodically for 36 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
-
-
Illinois
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Chicago, Illinois, Estados Unidos, 60637
- University of Chicago
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
Histologically or cytologically confirmed non-small cell lung carcinoma (NSCLC) meeting the following criteria:
The following subtypes are eligible:
- Adenocarcinoma (including bronchoalveolar)
- Large cell carcinoma (including giant and clear cell carcinomas)
- Poorly differentiated carcinoma
- No squamous cell histology
- Unresectable stage II-III disease
- Tumor must not invade the trachea or major arterial or venous structures
Measurable or evaluable disease
- Measurable disease defined as ? 1 lesion that can be accurately measured in ? 1 dimension as ? 20 mm with conventional techniques or as ? 10 mm with spiral CT scan
- No evidence of CNS disease, including primary brain tumor or brain metastases
- ECOG performance status (PS) 0-1 or Karnofsky PS 60-100%
- Life expectancy > 6 months
- Granulocyte count ? 1,500/mm³
- Platelet count ? 100,000/mm³
- Bilirubin < 1.25 times upper limit of normal (ULN)
- AST < 2.5 times ULN
- Creatinine normalOR creatinine clearance ? 60 mL/min
- FEV_1 ? 1.0 liters
- 24-hour urine protein < 1,000 mg (for patients with urine protein:creatinine ratio [by urine analysis] > 1.0)
- No hemoptysis within the past 12 months (defined as bright red blood in sputum of > 1 teaspoon)
- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- No history of allergic reactions attributed to carboplatin or taxane
- No serious or nonhealing wound, ulcer, or bone fracture
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
- No significant traumatic injury within the past 14 days
No clinically significant cardiovascular disease, including any of the following:
- Cerebrovascular accident within the past 6 months
- Uncontrolled hypertension
- Myocardial infarction or unstable angina within the past 6 months
- New York Heart Association class II-IV congestive heart failure
- Serious cardiac arrhythmia requiring medication
- Unstable angina pectoris
- Clinically significant peripheral vascular disease
- No known bleeding diathesis or coagulopathy
- No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
No uncontrolled intercurrent illness including, but not limited to, the following:
- Ongoing or active infection
- Psychiatric illness or social situations that would limit study compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ? 6 months after completion of study treatment
- No HIV positivity
- No prior chemotherapy
- No prior epidermal growth factor receptor-targeted therapy
- No prior vascular endothelial growth factor-targeted therapy
- No prior chest radiotherapy
- No major surgery or open biopsy within the past 14 days
No concurrent treatment with full-dose anticoagulation
Low-dose anticoagulants (e.g., warfarin) to maintain patency of central venous catheter allowed provided all of the following criteria are met:
- Daily dose of warfarin < 1 mg
- INR < 1.5
- No other concurrent investigational agents
- No concurrent major surgical procedures
- No other concurrent anticancer agents or therapies
- No concurrent chronic treatment with aspirin (> 325 mg daily) or nonsteroidal anti-inflammatory agents
- No dexamethasone as an antiemetic during chemoradiotherapy
- No colony-stimulating factors during chemoradiotherapy
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Treatment (paclitaxel, carboplatin, bevacizumab, radiation)
Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, 36, and 43 and bevacizumab IV over 30-90 minutes on days 1, 15, 29, and 43. Patients also undergo chest radiotherapy 5 days a week for 7 weeks beginning on day 1. Consolidation therapy: Beginning 4-5 weeks after completion chemoradiotherapy, patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 1 hour followed by bevacizumab IV over 30 minutes. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. |
Estudos correlativos
Dado IV
Outros nomes:
Dado IV
Outros nomes:
Dado IV
Outros nomes:
Submeta-se a radioterapia conformada tridimensional
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Safety and feasibility
Prazo: Up to 36 months
|
Up to 36 months
|
In-field toxicity, defined as bleeding or perforation of the tracheobronchial or gastrointestinal structures within the radiation field
Prazo: Up to 36 months
|
Up to 36 months
|
Clinical response
Prazo: Up to 36 months
|
Up to 36 months
|
Correlation of levels of angiopoietin-2 and vascular endothelial growth factor receptor-2 with clinical response
Prazo: Up to 36 months
|
Up to 36 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Everett Vokes, University of Chicago
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças Respiratórias
- Neoplasias por Tipo Histológico
- Neoplasias
- Doenças pulmonares
- Neoplasias por local
- Adenocarcinoma
- Carcinoma
- Neoplasias Glandulares e Epiteliais
- Neoplasias do Trato Respiratório
- Neoplasias Torácicas
- Carcinoma Broncogênico
- Neoplasias Brônquicas
- Neoplasias Pulmonares
- Carcinoma pulmonar de células não pequenas
- Adenocarcinoma de Pulmão
- Adenocarcinoma Brônquio-Alveolar
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Antineoplásicos
- Fatores imunológicos
- Moduladores de Tubulina
- Agentes Antimitóticos
- Moduladores de Mitose
- Agentes Antineoplásicos Fitogênicos
- Inibidores de angiogênese
- Agentes Moduladores da Angiogênese
- Substâncias de crescimento
- Inibidores de crescimento
- Carboplatina
- Paclitaxel
- Anticorpos
- Imunoglobulinas
- Bevacizumabe
- Anticorpos Monoclonais
- Agentes Antineoplásicos Imunológicos
Outros números de identificação do estudo
- NCI-2012-02718 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- N01CM62201 (Concessão/Contrato do NIH dos EUA)
- P30CA014599 (Concessão/Contrato do NIH dos EUA)
- 7213 (Outro identificador: CTEP)
- UCCRC-14576A
- CDR0000491998
- NCI-7213
- 14576A (Outro identificador: University of Chicago)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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