NCT01607554终止1 期
A Pilot, Non-Randomized Phase II Protocol of Irinotecan for Patients With Previously Treated, Advanced, Non-Small Cell Lung Cancer With High ISG 15 Expression
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 3
- 主要终点
- Tumor Response
研究概览
简要总结
Certain genetic factors can affect a patient's potential sensitivity to therapeutic drugs and other agents. There is a factor called ISG15 which might help doctors better identify patients with advanced non-small cell lung cancer (NSCLC) whose tumors may be more sensitive to the drug called Irinotecan. This factor is elevated in roughly 30% of NSCLC cases. Irinotecan is an agent that inhibits the enzyme called topoisomerase I that is involved in cell growth, and it has been FDA approved for 17 years for another type of cancer.
详细描述
The goal of this trial is to demonstrate the potential clinical benefit of targeted irinotecan chemotherapy in NSCLC patients whose tumors display a specific phenotype that is associated with increased sensitivity to this drug, ISG15H.
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
- •INCLUSION:
- •18 years of age or older Have received prior chemotherapy for histologically proven advanced non-small cell lung cancer, up to 3 prior treatments Tumors display high ISG15 (ISG15H) at screening Life expectancy of at least 12 weeks ECOG/Zubrod performance status of 0-2 Provide informed consent permission to participate
- •Adequate bone marrow function as follows:
- •Absolute neutrophil count of greater than or equal to 1,500 or cells/mm3, and 2) Platelet count greater than or equal to 100,000/mm3 and 3) Absence of a regular red blood cell transfusion requirement
- •Adequate hepatic function with:
- •Total bilirubin less than or equal to 4.0 mg/dl, and
- •SGOT or SGPT less than or equal to four times ULN
- •Adequate renal function as defined by:
- •Serum creatinine less than or equal to 1.5 x ULN
排除标准
- •Symptomatic brain metastases
- •Pregnant women or nursing mothers
- •Patients of child bearing potential must use adequate contraception.
- •May not be receiving other concurrent chemotherapy or radiation therapy
- •Severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections
- •Previous hypersensitivity reaction to camptothecins
研究组 & 干预措施
Irinotecan
Experimental
The starting dose of irinotecan for the study is 180 mg/m2, given intravenously every 14 days. Each 14 day period will constitute one cycle of treatment.
干预措施: Irinotecan (Drug)
结局指标
主要结局
Tumor Response
时间窗: 8 weeks
Change in tumor size will be measured by CT scan using RECIST criteria.
次要结局
- Time to Progression (TTP)(Up to 100 months)
- Retrospectively Evaluate the Role of Tumor SULF2 Gene Methylation Status in Treatment Efficacy(1 year)
- Toxicity of Irinotecan Salvage Chemotherapy(2 days preceding each cycle of therapy)
- Progression Free Survival (PFS)(Up to 100 months)
- Median Duration of Response(Up to 100 months)
- Median Overall Survival (OS)(100 months)
研究者
研究点 (3)
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