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Dasatinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

2019年2月8日 更新者:National Cancer Institute (NCI)

Phase II Study of Dasatinib in Non Small Cell Lung Cancer

Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well dasatinib works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

研究概览

详细说明

PRIMARY OBJECTIVES:

I. Determine the progression-free survival at 12 weeks in patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with dasatinib.

SECONDARY OBJECTIVES:

I. Determine the rate of response in patients treated with this drug. II. Examine the relationship between clinical response to this drug and epidermal growth factor receptor (EGFR) mutational status, EGFR copy number, and (phosphorylated Src) pSrc expression levels in pre-treatment tumor biopsies.

III. Determine the toxicity of this drug.

OUTLINE:

Patients received oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Previously obtained paraffin-embedded tumor tissue samples are analyzed by polymerase chain reaction and fluorescent in situ hybridization (FISH) for epidermal growth factor receptor and by immunohistochemistry for pSrc expression.

研究类型

介入性

注册 (实际的)

35

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

    • Texas
      • Houston、Texas、美国、77030
        • M D Anderson Cancer Center

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:

  • Platelet count >= 100,000/mm^3
  • Histologically or cytologically confirmed non-small cell lung cancer meeting 1 of the following criteria:

    • Stage IV disease
    • Stage IIIB disease with pleural effusion
    • Recurrent disease after surgery or radiotherapy
  • Measurable disease, defined as >= 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
  • Previously treated brain metastasis allowed, provided there is no bleeding, no midline shift, no need for steroids or anti-convulsants, and no symptoms
  • Must agree to obtain residual tumor tissue available from the existing diagnostic biopsy tumor tissue
  • Eastern cooperative oncology group (ECOG) performance status (PS) 0-1 OR Karnofsky PS 60-100%
  • Life expectancy > 12 weeks
  • White blood cell (WBC) >= 3,000/mm^3
  • Absolute neutrophil count >= 1,500/mm^3
  • Bilirubin =< 1.5 times upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and ALT =< 2.5 times ULN
  • Creatinine =< 3 times ULN OR Creatinine clearance >= 60 mL/min
  • No uncontrolled congestive heart failure or potentially life-threatening arrhythmia
  • No angina at rest
  • No neuropathy >= grade 2
  • No chronic diarrhea or history of inflammatory bowel disease
  • No history of pulmonary fibrosis (other than in an irradiated field)
  • No other concurrent serious medical illness
  • O2 saturation > 92% on room air
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reactions to compounds of similar chemical or biological composition to dasatinib
  • No heart rate-corrected QT interval (QTc) prolongation (i.e., QTC >= 480 msec) or other significant ECG abnormalities that could lead to adverse effects if the QTc interval were prolonged
  • No medical condition that impairs the ability to swallow, retain, or absorb dasatinib including, but not limited to, any of the following:

    • Gastrointestinal tract disease resulting in an inability to take oral medication, requirement for IV alimentation, prior surgical procedures affecting absorption, active peptic ulcer disease
  • No myocardial infarction or ventricular tachyarrhythmia within the past 6 months
  • left ventricular ejection fraction (LVEF) normal
  • No major conduction abnormality (unless cardiac pacemaker is present)
  • No ongoing or active infection
  • No history of significant bleeding disorder (congenital [von Willebrand's disease] or acquired [antifactor VIII antibodies])
  • No psychiatric illness or social situation that would preclude study compliance
  • No prior chemotherapy or biologic therapy for recurrent or metastatic non-small cell lung cancer
  • Adjuvant cytotoxic chemotherapy after surgical resection or chemotherapy with radiation for locally advanced disease (curative intent) allowed provided disease recurrence >= 3 months after completion of last chemotherapy dose
  • Measurable disease must be outside the radiotherapy port OR clearly growing inside the port
  • No prior radiotherapy to >= 25% of the marrow-containing skeleton
  • At least 7 days since prior and no concurrent medications that are inhibitors or inducers of CYP3A4
  • At least 7 days since prior and no concurrent agents with proarrhythmic potential
  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies
  • No concurrent antiretroviral therapy for HIV-positive patients
  • No concurrent systemic antacids (H2 receptor antagonists and proton pump inhibitors)
  • Locally acting antacids allowed except for 2 hours before and after dasatinib administration

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:Arm I
Patients received oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
口头给予
其他名称:
  • BMS-354825
  • 赛赛尔

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
Number of Participants With Objective Response (Complete Response (CR) or Partial Response (PR))
大体时间:12 weeks
Objective response defined as participants with Complete Response (CR) or Partial Response (PR) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. RECIST definitions are Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (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. Response measured by tumor size on computed tomography scans and by metabolic activity on positron emission tomography scans.
12 weeks
Progression-free Survival (PFS)
大体时间:Time from start of treatment to time of progression or death, assessed at 2 months
Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death.
Time from start of treatment to time of progression or death, assessed at 2 months

其他结果措施

结果测量
大体时间
Time to Progression (TTP)
大体时间:Time from start of treatment to time of progression or death, assessed radiographically every 6 weeks
Time from start of treatment to time of progression or death, assessed radiographically every 6 weeks
Epidermal Growth Factor Receptor (EGFR) Mutational Status
大体时间:Baseline
Baseline
Epidermal Growth Factor Receptor (EGFR) Copy Number
大体时间:Baseline
Baseline
Phospho-Src (pSrc) Expression
大体时间:Baseline
Baseline

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:Faye Johnson、M.D. Anderson Cancer Center

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

2007年3月1日

初级完成 (实际的)

2012年4月1日

研究完成 (实际的)

2012年4月1日

研究注册日期

首次提交

2007年4月9日

首先提交符合 QC 标准的

2007年4月9日

首次发布 (估计)

2007年4月11日

研究记录更新

最后更新发布 (实际的)

2019年3月5日

上次提交的符合 QC 标准的更新

2019年2月8日

最后验证

2019年2月1日

更多信息

与本研究相关的术语

其他研究编号

  • NCI-2009-00225 (注册表标识符:CTRP (Clinical Trial Reporting Program))
  • P30CA016672 (美国 NIH 拨款/合同)
  • N01CM62202 (美国 NIH 拨款/合同)
  • 7798 (其他标识符:CTEP)
  • CDR0000538668
  • 2006-0593 (其他标识符:M D Anderson Cancer Center)

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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