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

5 de enero de 2017 actualizado 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

46

Fase

  • Fase 2

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

  • 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

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

14 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

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: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Droga: 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).
Otros nombres:
  • Alimata
Droga: Carboplatin
AUC 6.0 IV on Day 1 of every 3-week treatment cycle for a total of 4 cycles (12 weeks).
Otros nombres:
  • 41575-94-4

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
3-Year Overall Survival Rate
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Objective Tumor Response
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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

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

Patrocinador

SCRI Development Innovations, LLC

Colaboradores

Eli Lilly and Company

Investigadores

  • Silla de estudio: David R Spigel, M.D., SCRI Development Innovations, LLC

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 junio de 2009

Finalización primaria (Actual)

1 de agosto de 2015

Finalización del estudio (Actual)

1 de septiembre de 2015

Fechas de registro del estudio

Enviado por primera vez

19 de mayo de 2009

Primero enviado que cumplió con los criterios de control de calidad

20 de mayo de 2009

Publicado por primera vez (Estimar)

21 de mayo de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de febrero de 2017

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

5 de enero de 2017

Última verificación

1 de enero de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • SCRI LUN 186

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

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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