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A Study Comparing of Two Different Chemotherapy Regimens, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

21 de novembro de 2011 atualizado por: Eli Lilly and Company

A Randomized Phase 2 Study Comparing Pemetrexed Plus Best Supportive Care With Best Supportive Care as Maintenance, Following First-Line Treatment With Pemetrexed-Cisplatin, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

This is a multicenter, open-label, randomized, two-arm Phase 2 study comparing pemetrexed plus best supportive care with best supportive care alone as maintenance therapy following first-line treatment with a pemetrexed-cisplatin combination in patients with advanced non-squamous non-small cell lung cancer.

A total of approximately 100 patients are planned to be enrolled, and following completion of four cycles of pemetrexed-cisplatin (Induction Phase) those patients in which disease progression has not occurred will be randomized in a 2:1 ratio to one of two treatment arms (Maintenance Phase): Arm A (pemetrexed plus best supportive care) or Arm B (best supportive care alone).

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

106

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

  • Arábia Saudita
      • Riyadh, Arábia Saudita, 11211
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Egito
      • Assiut, Egito, 0000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Cairo, Egito, 11372
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mounofia, Egito, 32514
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Líbano
      • Beirut, Líbano
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

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:

  1. You must be at least 18 years old
  2. You must have been diagnosed with non-squamous non-small cell lung cancer (NSCLC)
  3. You must have had no prior systemic anticancer therapy for lung cancer
  4. You must live close enough to the study doctor to be able to visit regularly for follow up
  5. You must have signed informed consent form indicating your willingness to take part in this study
  6. Your laboratory and medical history and tests must meet study requirements

Exclusion criteria:

  1. Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
  2. Prior radiotherapy and surgery should be completed at least 4 weeks prior to initiation of treatment
  3. Serious concomitant systemic disorder (e.g., active infection including human immunodeficiency virus, or unstable cardiovascular disease)
  4. Prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer unless treated at least 5 years previously with no subsequent evidence of recurrence
  5. Brain metastasis
  6. Presence of clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry
  7. Significant weight loss (greater than 10%), over the previous 6 weeks before study entry
  8. Concurrent administration of any other antitumor therapy
  9. Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents such as piroxicam)
  10. Inability or unwillingness to take folic acid, dexamethasone (or equivalent) or vitamin B12 supplementation
  11. Pregnancy or breast-feeding
  12. You are allergic to pemetrexed

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: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: A: Pemetrexed + Best Supportive Care

Pemetrexed: 500 milligrams per square meter (mg/m²) , intravenous (IV), Day 1 of each 21-day cycle for 6 cycles

Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
Medicamento: pemetrexed
500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles
Outros nomes:
  • Alimta
  • LY231514
Medicamento: Best Supportive Care
Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
Comparador Ativo: B: Best Supportive Care
Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
Medicamento: Best Supportive Care
Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Progression Free Survival During Maintenance Phase
Prazo: Randomization to progression of disease (PD) or date of death from any cause up to 30.9 months
Progression free survival is defined as the time from randomization until the date of progression of disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in maintenance phase uses the last lesion assessment prior to randomization as the baseline assessment.
Randomization to progression of disease (PD) or date of death from any cause up to 30.9 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Progression Free Survival During Overall Period (Induction Phase [IP] + Maintenance Phase [MP])
Prazo: First dose of study drug during IP to PD or date of death from any cause up to 33.6 months
Progression-free survival in overall period is defined as the time from the date of first dose of study drug during IP until the date of PD or death from any cause. PD was determined using RECIST criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in overall period uses the screening lesion assessment prior to the induction phase as the baseline assessment.
First dose of study drug during IP to PD or date of death from any cause up to 33.6 months
Overall Survival During Maintenance Phase
Prazo: Randomization to PD or date of death from any cause up to 31.3 months
Overall survival in maintenance phase is defined as the time from randomization to death. Participants who were alive were censored at the last contact.
Randomization to PD or date of death from any cause up to 31.3 months
Overall Survival During Overall Period (IP + MP)
Prazo: First dose of study drug during IP to PD or date of death from any cause up to 34.1 months
Overall survival in overall period is defined as the time from first dose of study drug during IP to death. Participants who were alive were censored at the last contact.
First dose of study drug during IP to PD or date of death from any cause up to 34.1 months
Number of Participants With Adverse Events (AEs) During Overall Period
Prazo: First dose of study drug during IP through overall study completion (up to 34.3) months
The list of serious adverse events (SAEs) and other non-serious adverse events (AEs) are in Adverse Events Section.
First dose of study drug during IP through overall study completion (up to 34.3) months
Tumor Response Rate and Disease Control Rate After Induction Phase (IP)
Prazo: Randomization to measured PD up to 31.4 months
Tumor response rate (%) is the number of responders (participants with best response of CR or PR) divided by the number of participants qualified for tumor response according to RECIST criteria multiplied by 100. Disease control rate is percentage of participants with a best response of stable disease [SD], PR, or CR. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; PD is≥20% increase in sum of longest diameter of target lesions. SD= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Randomization to measured PD up to 31.4 months

Colaboradores e Investigadores

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

Patrocinador

Eli Lilly and Company

Investigadores

  • Diretor de estudo: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9am to 5pm Eastern Time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

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

1 de janeiro de 2008

Conclusão Primária (Real)

1 de dezembro de 2010

Conclusão do estudo (Real)

1 de dezembro de 2010

Datas de inscrição no estudo

Enviado pela primeira vez

17 de janeiro de 2008

Enviado pela primeira vez que atendeu aos critérios de CQ

31 de janeiro de 2008

Primeira postagem (Estimativa)

1 de fevereiro de 2008

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

26 de dezembro de 2011

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de novembro de 2011

Última verificação

1 de novembro de 2011

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 11839 (DAIDS ES)
  • H3E-EZ-S114 (Outro identificador: Eli Lilly and Company)

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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