Phase I Study of the Combination of Icotinib and Arsenic Trioxide in Treating Non-small-cell Lung Cancer Patients With Resistance to EGFR-TKI
试验速览
- 阶段
- 1 期
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of Participants with Serious and Non-Serious Adverse Events
研究概览
简要总结
The NSCLC patients who experienced good clinical responses to an EGFR-TKI will inevitably develop acquired resistance. A great deal of research are focusing on this issue. Arsenic trioxide showed efficacy and safety in acute promyelocytic leukemia, multiple myeloma and other solid tumors. Moreover, preclinical studies showed arsenic trioxide can reduce the resistance of tumor cells to chemotherapy and TKIs.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed stage IIIB/IV lung cancer with EGFR mutation
- •Progressed after platinum-based chemotherapy
- •The last anti-tumor therapy before entering this study must be gefitinib, erlotinib or icotinib, and the duration for tumor response must be no less than 4 months, or the duration for stable disease must be no less than 6 months
- •With a measurable disease with conventional CT) according to RECIST Criteria
- •WHO performance status(PS)<= 2
- •N>=1.5×109/L, Plt>=1.0×109/L,Hb>=9g/dL; AST&ALT should <2.5ULN(without liver metastasis) or <5ULN(with liver metastasis).TBIL<=1.5ULN.
- •Signed and dated informed consent before the start of specific protocol procedures.
排除标准
- •Allergic to icotinib or arsenic trioxide.
- •Patients with metastatic brain tumors with symptoms.
- •Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
研究组 & 干预措施
Icotinib and arsenic trioxide
Icotinib is administered 125 mg three times per day, until disease progression or untolerated toxicity.
Arsenic trioxide is administered by intravenous injection with an initial dose of 4mg/m2 per day for day 1 to day 14 every 21 days.
Three dose levels, 4mg/m2, 6mg/m2 and 8mg/m2 will be evaluated according to predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 2 patients developed a DLT. There was no further dose escalation when this dose was achieved.
干预措施: Icotinib (Drug)
Icotinib and arsenic trioxide
Icotinib is administered 125 mg three times per day, until disease progression or untolerated toxicity.
Arsenic trioxide is administered by intravenous injection with an initial dose of 4mg/m2 per day for day 1 to day 14 every 21 days.
Three dose levels, 4mg/m2, 6mg/m2 and 8mg/m2 will be evaluated according to predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 2 patients developed a DLT. There was no further dose escalation when this dose was achieved.
干预措施: Arsenic trioxide (Drug)
结局指标
主要结局
Number of Participants with Serious and Non-Serious Adverse Events
时间窗: Up to 8 weeks
次要结局
- Time to death(Up to 24 months)
- Progression-free survival(Up to 4 months)