Randomized Phase II Study of Suramin and Docetaxel Versus Docetaxel in Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Progression-free Survival in Months
研究概览
简要总结
The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings.
详细描述
The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings.
Secondary objectives include:
- To compare response rate of patients in both treatment arms
- To compare overall survival of patients in both treatment arms
- To compare toxicity in both treatment arms
- To determine whether the survival benefit from suramin is associated with reduced M-phase entry in peripheral blood lymphocytes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Pathologically proven diagnosis of non-small cell lung cancer
- •Documented disease progression after first-line chemotherapy for non-small cell lung cancer
- •Stable and treated CNS metastasis is allowed
- •Radiation must be completed at least 2 weeks prior to starting protocol treatment
- •Major surgery must be completed at least 4 weeks prior to starting protocol treatment
- •ECOG performance status 0-2
- •Sexually active patients must use adequate contraception
- •Adequate bone marrow function
- •Adequate renal function
- •Adequate liver function
排除标准
- •Severe hypersensitivity reaction to docetaxel
- •Pre-existing grade 3 or 4 neuropathy
- •Women who are pregnant or breastfeeding
- •Uncontrolled intercurrent illness
- •Receipt of 3 or more prior chemotherapy regimens
研究组 & 干预措施
Docetaxel
干预措施: Docetaxel (Drug)
Docetaxel plus Suramin
干预措施: Suramin (Drug)
Docetaxel plus Suramin
干预措施: Docetaxel (Drug)
结局指标
主要结局
Progression-free Survival in Months
时间窗: Up to 1 year
Compare progression-free survival (PFS) in participants with advanced NSCLC treated with docetaxel with or without suramin after failure of first-line chemotherapy. PFS is defined as the duration of time from the time of randomization to time of disease progression or death, whichever occurs first.
次要结局
- Number of Participants With Toxicity/Adverse Events From Treatment(Up to 2 years)
- Response Rate Per RECIST 1.1 Criteria(Up to 1 year)
- Overall Survival(Up to 50 months)
- Evaluation of Peripheral Blood Lymphocytes for DNA Damage-induced Checkpoint Control.(Baseline)