NCT01967095已完成1 期
A Phase 1 Trial of Low Dose Daily Erlotinib in Combination With High Dose Twice Weekly Erlotinib in Patients With EGFR-Mutant Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 5
- 主要终点
- to determine the maximum tolerated dose (MTD)
研究概览
简要总结
The purpose of this study is to test the safety of different ways of taking erlotinib. The investigators want to find out what effects, good and/or bad, combination daily low dose and twice weekly high dose erlotinib has on the patient and lung cancer. The investigators are also seeing whether different schedules of erlotinib are better at treating lung cancer that has spread to the central nervous system.
CNS expansion phase:
The pulse continuous regimen will be then assess in patients with EGFR mutant lung cancers and CNS involvement. An additional expansion cohort (A) will enroll 19 patients with newly diagnosed EGFR mutant lung cancer with CNS involvement at diagnosis. The patients in the expansion cohorts will undergo the same treatment plan as the patients in the dose expansion cohort. A patient in the expansion cohorts will not be replaced if he/she does not finish the first 28 day (cycle 1) treatment period.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MSKCC pathologically-proven diagnosis locally advanced Stage III not amenable to definitive, curative treatment or Stage IV or recurrent non-small cell lung cancer
- •Documented presence of EGFR mutation confirmed by MSKCC or a local facility.
- •No prior treatment with erlotinib, gefitinib, or other EGFR tyrosine kinase inhibitors
- •Age ≥ 18 years
- •Measurable (RECIST 1.1) indicator lesion not previously irradiated.
- •Karnofsky Performance Status ≥ 70%
- •Ability to take oral medications
- •A negative serum pregnancy test obtained within 4 weeks prior to the start of treatment in all women of child-bearing potential.
- •All women of child bearing potential and sexually active men must agree to use adequate methods of birth control throughout the study which includes use of oral contraceptives with an additional barrier methods, double barrier methods, Depo-Provera, permanent sterilization of patient or partner or total abstinence.
- •Expansion A:
- •brain metastases or leptomeningeal not previously treated with radiation or surgery
排除标准
- •Inadequate recovery from any toxicity related to prior treatment (to Grade 2 or baseline).
- •Inadequate hematologic function defined as ANC < 1000 cells/mm³, Platelet count <75,000/mm³ or Hemoglobin <9.0g/dL.
- •Inadequate hepatic function defined by AST/ALT >3x upper limit of normal (ULN), Total bilirubin>2x ULN, Alkaline phosphatase >3x ULN.
- •Symptomatic brain metastasis requiring radiation therapy or escalating doses of steroids.
- •Patients with clinically stable brain metastases or leptomeningeal disease (previously treated or untreated) are eligible. Patients in expansion cohort A must have at least one untreated CNS lesion
- •Women who are breastfeeding or pregnant.
- •Any evidence of clinically active interstitial lung disease.
研究组 & 干预措施
erlotinib
Experimental
This protocol is a phase 1, single arm, open label study of combination daily low dose erlotinib plus twice weekly high dose erlotinib in patients with EGFR-Mutant lung cancer who have not yet received erlotinib or gefitinib. Six dose levels are planned for escalation, with the pulse dose erlotinib increasing.
Expansion cohort A: Treat an additional 19 pts at the MTD with CNS involvement at diagnosis
干预措施: erlotinib (Drug)
结局指标
主要结局
to determine the maximum tolerated dose (MTD)
时间窗: 1 year
The study will use a standard 3+3 dose escalation design. Three to six patients will need to be enrolled at each dose level and assessed for DLT for 1 full cycle (28 days for cycle 1) before dose escalation decision is made.
次要结局
- Progression Free Survival (PFS)(1 year)
- to evaluate the safety profile(1 year)
- Overall survival (OS)(1 year)
- Response rate (RR)(1 year)
研究者
研究点 (5)
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