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Chemotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)

8 de abril de 2011 actualizado por: Eli Lilly and Company

Phase 3 Study of Pemetrexed Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy

The purpose of this study is to compare the efficacy and toxicity of pemetrexed and docetaxel administered on a 3-weekly schedule in the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have had prior chemotherapy.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

211

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Porcelana
      • Beijing, Porcelana, 101149
        • 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.
      • Guang Zhou, Porcelana, 510080
        • 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.
      • Hang Zhou, Porcelana, 310022
        • 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.
      • Nan Jing, Porcelana, 210002
        • 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.
      • Shanghai, Porcelana, 200433
        • 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.
      • Tianjin, Porcelana, 300060
        • 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.
      • Wu Han, Porcelana, 430030
        • 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.

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Histologic or cytologic diagnosis NSCLC (Stage IIIA, IIIB, or IV), not amenable to curative surgery or radiotherapy
  • At least one prior chemotherapy for palliative therapy
  • Response Evaluation Criteria In Solid Tumors (RECIST) criteria for disease status assessment
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

Exclusion Criteria:

  • Concurrent administration of any other tumor therapy
  • Pregnant or breast feeding
  • Serious concomitant disorders
  • Inability or unwillingness to take folic acid or vitamin B12 supplementation

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Docetaxel
Droga: docetaxel
75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment
Experimental: Pemetrexed
Droga: pemetrexed
500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment
Otros nombres:
  • Alimata
  • LY231514

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival
Periodo de tiempo: baseline to date of death from any cause (up to 24 months after study enrollment); amendment (up to 30 months after study enrollment)
Overall survival was defined as the time from the date of study enrollment to the date of death due to any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up. An amendment allowed for the collection of overall survival on an additional 43 survival events. At the time the original record was released, it was not possible to provide results with the 95% Confidence Interval (CI) since the upper limit was not calculable. The median and 95% CIs are now reported.
baseline to date of death from any cause (up to 24 months after study enrollment); amendment (up to 30 months after study enrollment)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Tumor Response
Periodo de tiempo: baseline to measured tumor response (up to 24 months after study enrollment)
Response based on Response Evaluation Criteria In Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions; SD (stable disease) = small changes that do not meet above criteria.
baseline to measured tumor response (up to 24 months after study enrollment)
Progression-Free Survival (PFS)
Periodo de tiempo: baseline to measured progressive disease (up to 24 months after study enrollment)
Progression-free survival (PFS) time was defined as the time from the date of study enrollment to the date of the first of the following events: objective disease progression or death due to any cause. For patients who were alive and had not progressed, PFS was censored at the last contact.
baseline to measured progressive disease (up to 24 months after study enrollment)
Duration of Response
Periodo de tiempo: time of response to progressive disease (up to 24 months)
Duration of tumor response is the duration from date of first objective status assessment of a complete or partial response to the first date of progression or death from any cause. For each patient who is not known to have died or to have had a progression of disease as of the data inclusion cut-off date, duration of tumor response was censored at the time of last prior contact. Due to the low number of patients in the analysis, the median duration of tumor response could not be calculated for the docetaxel arm. Available data are presented as "Number of Patients with Disease Progression".
time of response to progressive disease (up to 24 months)
Pharmacology Toxicity
Periodo de tiempo: first dose of study drug up to 24 months
Maximum common terminology criteria (CTC) Grade 3 or 4 toxicities possibly related to study drug are reported. The worst grade event per cycle is reported. Grades range from 0 (none) to 5 (death). Grade 3 events are severe and Grade 4 events are life-threatening.
first dose of study drug up to 24 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Eli Lilly and Company

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de octubre de 2006

Finalización primaria (Actual)

1 de diciembre de 2008

Finalización del estudio (Actual)

1 de junio de 2010

Fechas de registro del estudio

Enviado por primera vez

19 de octubre de 2006

Primero enviado que cumplió con los criterios de control de calidad

19 de octubre de 2006

Publicado por primera vez (Estimar)

23 de octubre de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

12 de abril de 2011

Última actualización enviada que cumplió con los criterios de control de calidad

8 de abril de 2011

Última verificación

1 de abril de 2011

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 10717
  • H3E-MC-JMID (Otro identificador: Eli Lilly and Company)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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