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Customizing First Line Chemotherapy in Advanced Non-Small Cell Lung Cancer (Customizing)

2014年1月19日 更新者:National Guard Health Affairs

A Pilot Study of Customizing First Line Chemotherapy in Advanced Non-Small Cell Lung Cancer Based on Molecular Markers

The study aims at piloting the concept of customization of chemotherapy based on molecular markers in patients with stage IIIB (with pleural effusion) and IV with performance status ≤ 2 with pathologically proven non-small cell lung cancer (NSCLC). The study will not test or compare individual regimen but rather it will test the approach of customization concept as a whole.

The results of this pilot study will help in designing more definitive trials in our patient population.

研究概览

详细说明

The treatment of advanced NSCLC cancer includes various chemotherapies with equivalent regimens that have reached a therapeutic plateau. The selection of these regimens is completely empirical and physician dependent. Potential predictors of specific agent efficacy exist in the form of tumor molecular markers that are a reflection of the individual's genetic make up. Thus our study aims at utilizing these markers to more efficiently select the regimen in order to maximize the benefit to the patients rather than using empiric approaches. Fortunately, each of our selected regimens contains active and well-studied agents in the treatment of lung cancer (Table 1). This pilot study will help us determine the benefit, and safety of this approach (not individual regimen). The study is not to compare individual regimens but it aims at testing the whole concept of customization of chemotherapy based on molecular markers to help us in the future at selecting regimens based on these markers and not empirically. The results then will be used to determine more definitive future studies.

Furthermore, circulating tumor cells in the blood represent the future distant metastases that result in disease progression to incurable stages. The circulating tumor cells have the ability to cross into vessels, travel in circulation, and exit the vessels into tissues where they have the capability to grow. Therefore, these cells may express different biological and molecular features from the stationary cells in the primary tumors. Therefore, exploiting these circulating tumor cells for augmenting treatment approaches is of vital importance and utility.

研究类型

介入性

注册 (实际的)

3

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

      • Riyadh、沙特阿拉伯
        • King Abdul Aziz Medical City for National Guard Health Affairs

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 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Microscopic diagnosis of NSCLC stages IIIB (with malignant pleural effusion) and IV
  2. Having adequate tissue sample to perform the markers testing
  3. Age ≥ 18 years
  4. No prior chemotherapy treatment for lung cancer (Surgery and radiotherapy are acceptable)
  5. No other concurrent cancer treatment
  6. Performance status of 0- 2 per ECOG scale (Appendix II)
  7. Adequate laboratory values as follows as follows:

    Absolute neutrophil count ≥ 1500/mm3 Platelet count ≥100, 000/ mm3 Total bilirubin ≤ 1.25X institutional upper normal level AST and ALT ≤ 3 X institutional upper normal level Serum creatinine ≤ 1.5 X institutional upper normal level

  8. Presence of measurable disease

Exclusion Criteria:

  1. Prior systemic treatment for lung cancer
  2. History of hypersensitivity to drugs used
  3. Diagnosis of other malignancy in the last 5 years excluding curatively treated non-melanoma skin cancer and in-situ cervical cancer
  4. Medical illness that puts the patient at significant risk per investigator's discretion
  5. Uncontrolled CNS disease. Patients with CNS metastatic disease treated with radiotherapy or surgery will be eligible if the CNS disease is stable 4 weeks after the treatment initiation without increase dose of steroids
  6. Positive pregnancy test or refusal to use contraception during treatment. (Gynecology consultant for contraception)

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:Cisplatin,Docetaxel,Gemzar, Premetrexed
Patients will receive treatment for up to six cycles of the assigned regimen unless there is disease progression or unacceptable toxicities. After treatment, the patients will be seen every 2 months for the first year, then every 3 months for the second year and every 6 months afterwards.
Patients will be assigned to treatment according to the molecular biological results which will analyze excision repair cross-complementing (ERCC1), ribonucleotide reductase subunit M1 (RRM1) and beta-tubulin genes in primary tumor cells which are present in tissues and peripheral blood.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Efficacy and Safety
大体时间:3 years
  1. Efficacy is measured by:

    • overall response rate (partial response and complete response) using RECIST Criteria
    • time to disease progression (TTP)
    • progression free survival (PFS)
    • overall survival (OS)
  2. To evaluate the Number of participants with Adverse Events and Serious Adverse Events.Safety will include 5 parameters to be collected for all patients who receive the study regimen which are:

    • Adverse Events
    • Laboratory Assessments
    • Vital Signs
    • Physical Examinations
    • ECG
3 years

次要结果测量

结果测量
措施说明
大体时间
Tumor marker
大体时间:3 years
  1. The molecular characteristics of circulating tumor cells harvested from peripheral blood
  2. Correlation between the markers of circulating tumor cells and primary tumor.
3 years

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:Abdulrahman Jazieh, MD/MPH、King Abdul Aziz Medical City for National Guard

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

2010年5月1日

初级完成 (实际的)

2013年5月1日

研究完成 (实际的)

2013年5月1日

研究注册日期

首次提交

2011年3月19日

首先提交符合 QC 标准的

2011年5月18日

首次发布 (估计)

2011年5月19日

研究记录更新

最后更新发布 (估计)

2014年1月22日

上次提交的符合 QC 标准的更新

2014年1月19日

最后验证

2014年1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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