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Preoperative Pemetrexed and Carboplatin for Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung Cancer

5 de janeiro de 2017 atualizado por: SCRI Development Innovations, LLC

Phase II Trial of Preoperative Pemetrexed and Carboplatin in Patients With Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung Cancer

The purpose of this multi-center Phase II trial is to examine the impact of pemetrexed/carboplatin in the preoperative treatment of patients with select stage IB, II,and III non-squamous NSCLC. Because patients with non-squamous type NSCLC have been shown to have better survival rates than patients with squamous tumors when given pemetrexed with a platinum agent, only patients with non-squamous NSCLC (adenocarcinoma, large cell, and undifferentiated), not including squamous histology, will be allowed to participate in this study. If this novel regimen proves to be safe and active in this setting, it will provide rationale for further investigation in a larger, prospective, randomized trial.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

46

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
    • Florida
      • Fort Myers, Florida, Estados Unidos, 33901
        • Florida Cancer Specialists
    • Georgia
      • Augusta, Georgia, Estados Unidos, 30901
        • Medical Oncology Associates of Augusta
      • Gainesville, Georgia, Estados Unidos, 30501
        • Northeast Georgia Medical Center
    • Kentucky
      • Louisville, Kentucky, Estados Unidos, 40207
        • Baptist Hospital East
    • Maryland
      • Bethesda, Maryland, Estados Unidos, 20817
        • Center for Cancer and Blood Disorders
      • Bethesda, Maryland, Estados Unidos, 20817
        • National Capital Clinical Research Consortium
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68114
        • Nebraska Methodist Cancer Center
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45242
        • Oncology Hematology Care
    • South Carolina
      • Columbia, South Carolina, Estados Unidos, 29210
        • South Carolina Oncology Associates, PA
    • Tennessee
      • Chattanooga, Tennessee, Estados Unidos, 37404
        • Chattanooga Oncology Hematology Associates
      • Nashville, Tennessee, Estados Unidos, 37023
        • Tennessee Oncology, PLLC
    • Virginia
      • Richmond, Virginia, Estados Unidos, 23235
        • Virginia Cancer Institute

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

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

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Histologically-confirmed NSCLC (adenocarcinoma, large cell, and undifferentiated). Patients with squamous histology are not eligible.
  2. Life expectancy of at least 12 weeks.

  3. Patients with the following stages of NSCLC:

    • T2 N0 tumors: Limited to tumors >=4 cm.
    • T1-2 N1 tumors.
    • T3 N0-1 tumors (excluding superior sulcus tumors): Including tumors involving the chest wall, proximal airway, or mediastinal pleura where preoperative radiotherapy is not planned.
    • T1-2 N2 tumors: For patients with N2 disease involving one zone (Upper zone (R), AP zone (L), subcarinal zone, or lower zone) and nodes <=2cm in diameter.
    • T4 N0-1 tumors (excluding superior sulcus tumors): T4 lesions other than malignant effusions where radiotherapy is not planned.
  4. Patients with clinical N2 involvement must have histologic confirmation by mediastinoscopy (or alternate biopsy procedure).
  5. Tumors should be considered potentially resectable.
  6. No evidence of extrathoracic metastatic disease.
  7. Patients must have measurable disease by RECIST criteria.
  8. Patients must be candidates (medically) for chemotherapy followed by surgical resection.
  9. Adequate recovery from recent surgery. At least 1 week must have elapsed from the time of a minor surgery; at least 3 weeks must have elapsed from the time of a major surgery.

  10. Laboratory values as follows:

    • Absolute neutrophil count (ANC) >=1500/μL
    • Hemoglobin (Hgb) >=10 g/dL
    • Platelets >=100,000/uL
    • AST/SGOT and ALT/SGPT within normal limits (WNL)
    • Total bilirubin within normal limits (WNL)
    • Calculated creatinine clearance >=45 mL/min
  11. ECOG Performance Status grade 0 or 1.
  12. The ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of Alimta.
  13. The ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.
  14. Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
  15. Patient must be accessible for treatment and follow-up.
  16. Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.

Exclusion Criteria:

  1. Patients with the following stages are excluded:

    • T1 N0;
    • T2 N0, with primary tumor <4 cm;
    • T1-2 N2, with multiple zones of N2 involvement;
    • T3-4 N2;
    • Any N3;
    • Any TxNxM1 disease; or
    • Any stage where surgery and/or chemoradiotherapy is the preferred initial approach in management, as deemed by the treating physician.
  2. Squamous or predominant squamous mixed histologies.
  3. Mixed small-cell and non-small cell histologies.
  4. Pulmonary carcinoid tumors.
  5. Presence of third space fluid which cannot be controlled by drainage.
  6. Use of erythropoietin as a hematopoietic growth factor is not allowed.
  7. Cardiac disease, including: congestive heart failure (CHF) > Class II per New York Heart Association (NYHA) classification; unstable angina (anginal symptoms at rest) or new-onset angina (i.e., began within the last 3 months), or myocardial infarction within the past 6 months; symptomatic CHF, unstable angina pectoris, cardiac arrhythmia, or cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  8. Women who are pregnant (positive pregnancy test) or lactating.
  9. Use of any non-approved or investigational agent within 30 days of administration of the first dose of study drug.
  10. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
  11. Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
  12. Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
  13. History of hypersensitivity to active or inactive excipients of any component of treatment.
  14. Inability to comply with study and/or follow-up procedures.

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: Pemetrexed/Carboplatin

4 cycles of preoperative treatment (1 Cycle = 21 days):

Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle; Carboplatin: AUC 6.0 by IV on Day 1 each cycle.
Medicamento: Pemetrexed
500 mg/m2 IV over 10 minutes on Day 1 of every 3-week treatment cycle for a total of 4 cycles (12 weeks).
Outros nomes:
  • Alimta
Medicamento: Carboplatin
AUC 6.0 IV on Day 1 of every 3-week treatment cycle for a total of 4 cycles (12 weeks).
Outros nomes:
  • 41575-94-4

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
3-Year Overall Survival Rate
Prazo: 36 months
The percentage of patients who were alive at 3 years from time of first study treatment until date of death from any cause. Overall survival is shown for the Intent-to-Treat population.
36 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Objective Tumor Response
Prazo: At 6 and 12 weeks
Objective Tumor Response defined as the percent of patients who completed up to 4 cycles of pre-operative chemotherapy and achieved a complete response (CR) or partial response (PR) assessed by Response Evaluation in Solid Tumors (RECIST) 1.0. Patients with stable disease (SD) or response to treatment were deemed surgical candidates. [CR=disappearance of all target tumors; PR= ≥30% decrease in the sum of the longest diameters of target tumors. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.]
At 6 and 12 weeks
Pathologic Response Rate
Prazo: weeks 15 -18
Percent of patients having a pathological complete or partial response (pCR or pPR) at surgery. pCR defined as complete removal of all tumor. pPR defined as residual viable tumor demonstrated in the resected specimen.
weeks 15 -18
Rate of Residual Disease as an Assessment of Pathological Partial Response (pPR)
Prazo: At 15-18 weeks
pPR was further assessed by the amount of residual tumor measured at surgery: microscopic residual disease = less than 1 centimeter (<1 cm); macroscopic residual disease = 1 centimeter or greater (≥1 cm).
At 15-18 weeks
Complete Resection Rate
Prazo: At weeks 15-18
The percent of patients who had surgical resection listed by procedure type: lobectomy or pneumonectomy, or resection of adjacent chest wall or mediastinal structures when appropriate. Surgery followed standard guidelines for resection of non-small-cell lung cancer (NSCLC).
At weeks 15-18

Colaboradores e Investigadores

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

Patrocinador

SCRI Development Innovations, LLC

Colaboradores

Eli Lilly and Company

Investigadores

  • Cadeira de estudo: David R Spigel, M.D., SCRI Development Innovations, LLC

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 junho de 2009

Conclusão Primária (Real)

1 de agosto de 2015

Conclusão do estudo (Real)

1 de setembro de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

19 de maio de 2009

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de maio de 2009

Primeira postagem (Estimativa)

21 de maio de 2009

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de fevereiro de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de janeiro de 2017

Última verificação

1 de janeiro de 2017

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • SCRI LUN 186

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Não

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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