A Double Blind Randomized Trial of Cediranib Versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 19
- 主要终点
- Overall Survival
研究概览
简要总结
RATIONALE: Cediranib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether cediranib is more effective than a placebo when given together with paclitaxel and carboplatin in treating patients with non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying how well cediranib works when given together with paclitaxel and carboplatin in treating patients with stage IIIB or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To compare overall survival of patients with stage IIIB-IV non-small cell lung cancer treated with cediranib vs placebo administered in combination with paclitaxel and carboplatin.
Secondary
- To compare the progression-free survival of patients treated with these regimens.
- To compare the objective response rates in patients treated with these regimens.
- To estimate time to response and response duration in patients treated with these regimens.
- To evaluate the nature, severity, and frequency of toxicities, including hemorrhage and hemoptysis, in patients treated with these regimens.
- To compare the pharmacokinetics of paclitaxel between the two arms in a subset of enrolled patients
- To compare the quality of life of patients treated with these regimens.
- To determine the incremental cost effectiveness and cost utility ratios for these regimens.
- To correlate the expression of tissue markers (at diagnosis) with outcomes and response in an exploratory fashion OUTLINE: This is a multicenter study. Patients are stratified by gender, center, disease stage (IIIB vs IV), weight loss (< 5% vs 5-10% vs unknown), and prior adjuvant chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
- Arm II: Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
Arm I Cediranib
Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
干预措施: carboplatin (Drug)
Arm I Cediranib
Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
干预措施: cediranib maleate (Drug)
Arm I Cediranib
Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
干预措施: paclitaxel (Drug)
Arm II Placebo
Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
干预措施: carboplatin (Drug)
Arm II Placebo
Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
干预措施: paclitaxel (Drug)
Arm II Placebo
Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
干预措施: placebo (Other)
结局指标
主要结局
Overall Survival
时间窗: at every 3 months visit throughout trial, a median of 13.1 months.
Medians of survival time, and their confidence intervals.
次要结局
- Progression-free Survival(at every 3 months visit throughout trial, a median of 12 months)
- Objective Tumor Response as Assessed by RECIST Criteria v1.1.(Every 6 weeks at the end of every 2 cycles during protocol treatment and every 12 weeks after protocol treatment until progression.)