A Phase II Trial of VInflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 3
- 主要终点
- Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
研究概览
简要总结
This clinical trial involves the administration of the chemotherapeutic medication vinflunine. Vinflunine is not approved by the FDA and is experimental in the treatment of extensive small cell lung cancer. The purpose of this research trial is to study the effectiveness of vinflunine in patients with relapsed extensive small cell lung cancer, evaluate the toxicity, and evaluate how long the response to this drug lasts.
详细描述
Eligible patients will receive vinflunine as a 15-20 minute intravenous (IV)infusion once every three weeks (21 days). This three week treatment period is called a cycle. Patients whose cancer has not grown or if it has decreased in size may receive up to 6 cycles of vinflunine. Evaluation will be conducted every other cycle.
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
- •Small cell lung cancer with progression after one previous chemotherapy or chemotherapy/radiation therapy regimen
- •Measurable or evaluable disease
- •Able to perform activities of daily living with minimal assistance
- •Adequate hematological, liver, and kidney function
- •Must give written informed consent prior to entry
排除标准
- •CNS involvement
- •Serious active infection or underlying medical condition
- •Significant history of uncontrolled cardiac disease
研究组 & 干预措施
Intervention
Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
干预措施: Vinflunine (Drug)
结局指标
主要结局
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
时间窗: 18 months
Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. The final response criteria assigned represented the best response obtained during treatment.
次要结局
- Duration of Response, the Length of Time, in Months, That Protocol Treatment Produced an Objective Improvement in Patients' Disease(18 months)
- Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death(18 months)
- Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease(18 months)