Phase II Study of Vinflunine and Cetuximab in the Second Line Treatment of Stage IIIB/IV Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Overall Tumor Response Rate as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Sum of Partial Responses (PR) and Complete Responses (CR).
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as vinflunine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and help kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Giving vinflunine together with cetuximab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving vinflunine together with cetuximab works as second-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Estimate the objective response rate in patients receiving vinflunine and cetuximab as second-line therapy for stage IIIB or IV non-small cell lung cancer.
Secondary
- Determine the progression-free survival of patients treated with this regimen.
- Determine the safety of this regimen in these patients.
- Determine the overall survival of patients treated with this regimen.
- Determine the duration of overall response in these patients.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Vinflunine + Cetuximab
Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.
干预措施: cetuximab (Biological)
Vinflunine + Cetuximab
Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.
干预措施: vinflunine (Drug)
结局指标
主要结局
Overall Tumor Response Rate as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Sum of Partial Responses (PR) and Complete Responses (CR).
时间窗: Baseline, after cycle 2, within 2 weeks of completing cycle 4
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Measurable lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques or as \> 10mm with spiral CT scan or nonmeasurable, but evaluable. Evaluable is nonmeasurable disease that includes ascites, malignant pleural/pericardial effusion, bone lesions, or marrow involvement.
次要结局
- Overall Survival(Every 30 days)
- Progression-free Survival(after cycle 2, within 2 weeks of completing cycle 4)
- Duration of Response(After cycle 4)