NCT01189435终止2 期
A Phase 2 Trial of Erlotinib Re-Challenge for Recurrent EGFR-mutant Lung Cancer in Patients Who Previously Received Adjuvant Erlotinib or Gefitinib
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- To Examine the Objective Response Rate (ORR) of Single-agent Erlotinib
研究概览
简要总结
The purpose of this study is to measure the ability of erlotinib to effectively treat recurrent lung cancer which carries an EGFR mutation lung cancer after prior treatment with erlotinib or gefitinib received in the post-surgical or post-radiation setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A history of stage I-IIIB NSCLC
- •Previously underdone definitive surgery or radiation
- •Received prior adjuvant treatment or neoadjuvant with erlotinib or gefitinib for a total of at least 3 months at any time
- •Stopped adjuvant erlotinib or neoadjuvant at least 2 months prior to date of first imaging demonstrating recurrence
- •Pathologic evidence of recurrent lung cancer, confirmed at MSKCC EGFR sensitizing mutation (point mutation in exons 18 or 21, or deletion in exon 19) must be documented in the primary or recurrent tumor
- •Tissue from their recurrent tumor must be submitted for EGFR mutation testing, and to evaluate for the presence of the T790M mutation (results do not need to have been reported to be eligible)
- •Measurable disease by RECIST; if received prior irradiation, then must have a target lesion outside the irradiated field
- •Signed informed consent
- •Age > or = to 21 years old
- •Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped
排除标准
- •Prior progressive disease while receiving erlotinib or gefitinib therapy
- •Patients with known pre-existing interstitial lung disease
- •Total bilirubin greater than 1.8 mg/dl, excepting patients known to have Gilbert's syndrome
- •AST or ALT greater than five times the upper limit of normal
- •Pregnant or lactating women
- •Medically unfit for erlotinib therapy as determined by treating oncologist
研究组 & 干预措施
erlotinib
Experimental
This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.
干预措施: erlotinib (Drug)
结局指标
主要结局
To Examine the Objective Response Rate (ORR) of Single-agent Erlotinib
时间窗: 2 years
in recurrent EGFR-mutant lung cancer, given to patients who previously received adjuvant erlotinib or gefitinib
次要结局
未报告次要终点
研究者
研究点 (1)
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