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Carboplatin, Paclitaxel, Selenomethionine, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

23 de octubre de 2017 actualizado por: Roswell Park Cancer Institute

Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination With Radiation for Patients With Unresectable Stage III Non-Small Cell Lung Cancer: A Phase II, Multi-Center Trial

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Selenomethionine may slow the growth of tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with selenomethionine and radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well selenomethionine works when given together with carboplatin, paclitaxel, and radiation therapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.

Descripción general del estudio

Descripción detallada

OBJECTIVES:

Primary

  • Determine the safety and tolerability of selenomethionine in combination with chemotherapy and radiotherapy in patients with unresectable stage IIIA or IIIB non-small cell lung cancer.
  • Determine if the incidence of excessive adverse events, in the form of esophagitis, pneumonitis, and myelosuppression, can be reduced with this regimen.

Secondary

  • Estimate response rate, failure-free survival, and overall survival of these patients.
  • Correlate selenium levels with degree of observed adverse events.

OUTLINE: This is a multicenter study.

Patients receive oral selenomethionine twice daily for 1 week and then once daily for 6 weeks. Patients also receive paclitaxel IV over 1 hour once weekly and carboplatin IV over 30 minutes once weekly for 6 weeks and undergo radiotherapy 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and weekly during treatment and analyzed by absorption spectrophotometry for selenium measurement of drug concentration

After the completion of study treatment, patients are followed periodically.

Tipo de estudio

Intervencionista

Inscripción (Actual)

16

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

    • New York
      • Buffalo, New York, Estados Unidos, 14263-0001
        • Roswell Park 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

18 años a 120 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following histologic subtypes:

    • Squamous cell carcinoma
    • Adenocarcinoma (including bronchoalveolar cell carcinoma)
    • Large cell anaplastic carcinoma (including giant and clear cell carcinoma)
  • Stage IIIA disease OR selected stage IIIB disease

    • T1-2, N2 disease OR T3, N2 or T4, N0-N2 disease (if based on tumor closeness to the carina, invasion of the mediastinum, or invasion of the chest wall)

      • Contralateral mediastinal disease (N3) allowed if all gross disease can be encompassed in the radiation boost field
  • Tumors adjacent to a vertebral body allowed unless there is demonstrable bone invasion

    • All gross disease must be able to be encompassed in the radiation boost field
    • No direct invasion of a vertebrae body
  • Unresectable or inoperable disease
  • Measurable disease
  • Suitable for radiotherapy, as deemed by the radiation oncologist
  • No scalene, supraclavicular, or contralateral hilar node involvement
  • Pleural effusion allowed provided it is transudate, cytologically negative, and non-bloody, and, according to the radiation oncologist, the tumor can be encompassed within a reasonable radiation field

    • Pleural effusion seen on chest CT scan, but not on chest x-ray, that is too small to tap is allowed
    • No exudative, bloody, or cytologically malignant effusions
  • No known brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 75,000/mm³
  • Total bilirubin ≤ 1.5 mg/dL
  • Creatinine normal
  • Alkaline phosphatase AND AST or ALT meeting 1 of the following criteria:

    • Alkaline phosphatase normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
    • Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
    • Alkaline phosphatase ≤ 5 times ULN AND AST or ALT normal
  • Able to swallow oral medications
  • No peripheral neuropathy > grade 1
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to selenomethionine or agents formulated with Cremophor EL
  • No concurrent uncontrolled illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Clinically significant cardiac arrhythmia
    • Psychiatric illness or social situations that would limit compliance with study requirements
  • No currently "active" second malignancy other than non-melanoma skin cancer

    • Patients are considered not to have an "active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • At least 2 weeks since prior formal exploratory thoracotomy (N2 node identified making patient ineligible for surgery)
  • No prior chemotherapy or radiotherapy for NSCLC
  • No prior taxanes or platinum drugs
  • No other concurrent investigational agents or anticancer therapy
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent chemotherapy or hormonal therapy, except for the following:

    • Steroids administered for adrenal failure or septic shock
    • Hormones administered for non-disease-related conditions (e.g., insulin for diabetes)
    • Glucocorticosteroids administered as antiemetics

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: CPSR
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
Estudio Correlativo
Oral Twice daily
Weekly IV
Weekly IV
Undergoing radiation Therapy

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Incidence of Grade 3-4 Esophagitis
Periodo de tiempo: During study treatment, up to 6 weeks
During study treatment, up to 6 weeks
Incidence of Grade 3-4 Pneumonitis
Periodo de tiempo: During study treatment, up to 6 weeks
During study treatment, up to 6 weeks
Incidence of Grade 3-4 Myelosuppression
Periodo de tiempo: During study treatment, up to 6 weeks
During study treatment, up to 6 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Response Rate
Periodo de tiempo: 1 month post-treatment, then q 3 months x 4
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
1 month post-treatment, then q 3 months x 4
Failure-free Survival
Periodo de tiempo: Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter.
Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter.
Overall Survival
Periodo de tiempo: Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter
Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter
Selenium Level by Incidence of SAE
Periodo de tiempo: Pre-treatment and every week for 6 weeks prior to chemotherapy.
Median Selenium level by Incidence of SAE. Mann-Whitney-Wilcoxon test was used to test the correlation between selenium levels and serious adverse events.
Pre-treatment and every week for 6 weeks prior to chemotherapy.

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Jorge Gomez, MD, Roswell Park Cancer Institute

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 agosto de 2010

Finalización del estudio (Actual)

1 de septiembre de 2010

Fechas de registro del estudio

Enviado por primera vez

7 de septiembre de 2007

Primero enviado que cumplió con los criterios de control de calidad

7 de septiembre de 2007

Publicado por primera vez (Estimar)

10 de septiembre de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de noviembre de 2017

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

23 de octubre de 2017

Última verificación

1 de octubre de 2017

Más información

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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