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Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Previously Treated Advanced Non-small Cell Lung Cancer

26 de junho de 2021 atualizado por: Christina S Baik, University of Washington

A Phase II Study of Weekly Abraxane for Patients With Advanced NSCLC With EGFR Mutations or With Durable Response to an EGFR Tyrosine Kinase Inhibitor Following Front Line Therapy With EGFR Tyrosine Kinase Inhibitors

This research study examines the use of Abraxane (paclitaxel albumin-stabilized nanoparticle formulation) in patients with lung cancer. Abraxane is a chemotherapy approved to treat patients with breast cancer. Doctors want to know if Abraxane is safe and effective in treating patients with lung cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) and epidermal growth factor receptor (EGFR) mutations.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

PRIMARY OBJECTIVES:

I. To evaluate the overall response rate of weekly nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) in patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations following front-line therapy with EGFR tyrosine kinase inhibitors (TKI).

SECONDARY OBJECTIVES:

I. To evaluate the safety profile of weekly nab-paclitaxel in patients with advanced NSCLC with EGFR mutations following front-line therapy with an EGFR TKI.

II. To evaluate the time-to-progression and overall survival.

OUTLINE:

Patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks and then every 3 months thereafter.

Tipo de estudo

Intervencional

Inscrição (Real)

26

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Alaska
      • Anchorage, Alaska, Estados Unidos, 99508
        • Anchorage Oncology Centre
      • Anchorage, Alaska, Estados Unidos, 99508
        • Katmai Oncology Group
      • Anchorage, Alaska, Estados Unidos, 99508
        • Providence Alaska Medical Center
    • Montana
      • Bozeman, Montana, Estados Unidos, 59715
        • Bozeman Deaconess Hospital
    • Washington
      • Kennewick, Washington, Estados Unidos, 99336
        • Kadlec Clinic Hematology and Oncology
      • Mount Vernon, Washington, Estados Unidos, 98274
        • Skagit Valley Hospital
      • Port Angeles, Washington, Estados Unidos, 98362
        • Olympic Medical Center
      • Redmond, Washington, Estados Unidos, 98052
        • Group Health Cooperative
      • Seattle, Washington, Estados Unidos, 98109
        • Fred Hutch/University of Washington Cancer Consortium
      • Spokane, Washington, Estados Unidos, 99216
        • Spokane Valley Cancer Center-Mission
      • Tacoma, Washington, Estados Unidos, 98415
        • MultiCare Health System
      • Wenatchee, Washington, Estados Unidos, 98801
        • Wenatchee Valley Hospital and Clinics

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Pathologically confirmed non-small cell lung cancer with documented EGFR mutation in tumor deoxyribonucleic acid (DNA) or complete/partial response to first line EGFR tyrosine kinase inhibitors with > or = to 6 months duration of response in patients who do not have a confirmed EGFR mutation
  • At least one site of measurable disease as determined by the Investigator, using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  • Progressive disease with radiographic evidence of disease progression per investigator assessment during therapy with an EGFR tyrosine kinase inhibitor in the metastatic setting; patients may continue EGFR inhibitor therapy throughout the screening period until the day prior to nab-paclitaxel treatment initiation
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 at the time of informed consent
  • Platelet count >= 100,000/uL
  • Absolute neutrophil count >= 1,500/uL
  • Hemoglobin >= 9 g/dL
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = < 2.5 times upper limit of normal
  • Alkaline phosphatase =< 2.5 times upper limit of normal, unless bone metastasis is present in the absence of liver metastasis
  • Bilirubin =< 1.5 mg/dL
  • Creatinine =< 1.5 mg/dL
  • Women of child-bearing potential (WOCP) and sexually active men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry, during treatment and for three months after completing treatment
  • Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential
  • Life expectancy of > 12 weeks
  • Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment

Exclusion Criteria:

  • Prior conventional cytotoxic chemotherapy for metastatic or recurrent disease; prior adjuvant, neoadjuvant or chemoradiotherapy for NSCLC is permitted, provided at least 6 months elapsed prior to documented metastatic recurrence
  • A single dose of a platinum doublet discontinued due to intolerability without evidence of disease progression is permitted
  • Patient is < 5 years free of another primary malignancy, except: a) if the other malignancy is basal cell carcinoma or cervical carcinoma in situ or b) if the other primary malignancy is not considered clinically significant and is requiring no active intervention
  • Progressive or symptomatic central nervous system (CNS) metastases; patients with known brain metastasis must have stable disease following treatment with surgery, radiation or both; in addition, they must be off corticosteroids
  • Radiotherapy within 7 days of study treatment
  • Peripheral neuropathy grade 2 or greater
  • Grade III/IV congestive heart failure, as defined by New York Heart Association (NYHA) criteria, or myocardial infarction within 6 months
  • Any serious or uncontrolled concomitant disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study
  • Patient has known chronic liver disease, e.g. diagnosis of chronic active hepatitis or cirrhosis
  • Major surgery within 21 days of study treatment; minor surgery within 2 weeks of study treatment; placement of vascular access device and biopsies allowed and is not considered major or minor surgery
  • Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent
  • Pregnant or breast feeding females

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

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 albumin-stabilized nanoparticle formula)
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Outro: Análise laboratorial de biomarcadores
Estudos correlativos
Medicamento: Formulação de Nanopartículas Estabilizadas com Albumina de Paclitaxel
Dado IV
Outros nomes:
  • ABI-007
  • Abraxane
  • Paclitaxel ligado à albumina
  • ABI 007
  • Nanopartícula estabilizada com albumina Paclitaxel
  • Paclitaxel Nanoparticulado Ligado a Albumina
  • Nanopartícula Paclitaxel
  • nab-paclitaxel
  • paclitaxel ligado a proteína

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Overall Response Rate (Complete and Partial Response) Defined by RECIST 1.1 Criteria
Prazo: Assessed every two cycles from date of first study therapy until documented disease progression, date of death, unacceptable toxicity, or withdrawal of patient consent, whichever occurs first, assessed up to 60 weeks.
The response rate as the proportion and 95% confidence interval of patients who achieved a complete response or partial response will be calculated.
Assessed every two cycles from date of first study therapy until documented disease progression, date of death, unacceptable toxicity, or withdrawal of patient consent, whichever occurs first, assessed up to 60 weeks.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Overall Percentage of Patients Experiencing Toxicity Within a Clinically Significant Category Defined as Neutropenia, Neutropenic Fever, or Neuropathy.
Prazo: Collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 64 weeks.
Toxicity rates will be described as percentage of patient who experienced a Grade 3 or higher clinically significant toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 64 weeks.
Overall Survival
Prazo: Assessed from date of patient consent until date of death from any cause or withdrawal of patient consent, whichever occurs first, assessed up to 305 weeks.
Will report as median values with their respective 95% confidence intervals will be reported. Time to event distribution will be estimated using Kaplan-Meier method.
Assessed from date of patient consent until date of death from any cause or withdrawal of patient consent, whichever occurs first, assessed up to 305 weeks.
Overall Percentage of Patients Experiencing Grade 3 or Higher Toxicity.
Prazo: Collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 64 weeks.
Toxicity rates will be described as percentage of patients experiencing Grade 3 or higher toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 64 weeks.
Time to Progression.
Prazo: Assessed from date of patient consent until documented disease progression, date of death from any cause, start of new anti-cancer therapy, or withdrawal of patient consent, whichever occurs first, assessed up to 60 weeks.
Reported as median values with their respective 95% confidence intervals for patients who were assessed. Time to event distribution will be estimated using the Kaplan-Meier method.
Assessed from date of patient consent until documented disease progression, date of death from any cause, start of new anti-cancer therapy, or withdrawal of patient consent, whichever occurs first, assessed up to 60 weeks.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Washington

Colaboradores

National Cancer Institute (NCI)
Celgene Corporation

Investigadores

  • Investigador principal: Christina Baik, Fred Hutch/University of Washington Cancer Consortium

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

2 de dezembro de 2012

Conclusão Primária (Real)

24 de outubro de 2017

Conclusão do estudo

29 de abril de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

13 de junho de 2012

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de junho de 2012

Primeira postagem (Estimativa)

15 de junho de 2012

Atualizações de registro de estudo

Última Atualização Postada (Real)

16 de julho de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de junho de 2021

Última verificação

1 de junho de 2021

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 7755 (Fred Hutch/University of Washington Cancer Consortium)
  • P30CA015704 (Concessão/Contrato do NIH dos EUA)
  • NCI-2012-00865 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
  • RG1712044 (Outro identificador: Fred Hutch/University of Washington Cancer Consortium)

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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