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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

2017年10月23日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

16

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New York
      • Buffalo、New York、美国、14263-0001
        • Roswell Park Cancer Institute

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 120年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:CPSR
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
相关研究
Oral Twice daily
Weekly IV
Weekly IV
Undergoing radiation Therapy

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Incidence of Grade 3-4 Esophagitis
大体时间:During study treatment, up to 6 weeks
During study treatment, up to 6 weeks
Incidence of Grade 3-4 Pneumonitis
大体时间:During study treatment, up to 6 weeks
During study treatment, up to 6 weeks
Incidence of Grade 3-4 Myelosuppression
大体时间:During study treatment, up to 6 weeks
During study treatment, up to 6 weeks

次要结果测量

结果测量
措施说明
大体时间
Response Rate
大体时间: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
大体时间: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
大体时间: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
大体时间: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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Jorge Gomez, MD、Roswell Park Cancer Institute

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2006年10月1日

初级完成 (实际的)

2010年8月1日

研究完成 (实际的)

2010年9月1日

研究注册日期

首次提交

2007年9月7日

首先提交符合 QC 标准的

2007年9月7日

首次发布 (估计)

2007年9月10日

研究记录更新

最后更新发布 (实际的)

2017年11月28日

上次提交的符合 QC 标准的更新

2017年10月23日

最后验证

2017年10月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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