A Phase II Study of ALIMTA® (Pemetrexed) and GEMZAR® (Gemcitabine) Every 14 Days Versus Pemetrexed and Gemcitabine Every 21 Days in Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Best Overall Tumor Response
研究概览
简要总结
This study is designed to evaluate Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8 every 21 days (Arm A) and Pemetrexed and Gemcitabine Day 1 every 14 days (Arm B) in patients with NSCLC. Each agent and sequence has well demonstrated antitumor activity respectively in patients with locally advanced or metastatic NSCLC. Therefore, it is reasonable to investigate the most optimal schedule for this combination, and which combination is associated with the most anti-tumor activity in the phase II arena.
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
- •histologic or cytologic diagnosis of NSCLC Stage IIIB or IV
- •no prior systemic chemotherapy for advanced Non-Small Cell Lung Cancer
- •Prior radiotherapy must be completed at least 4 weeks before study enrollment.
排除标准
- •estimated life expectancy of 12 weeks
- •a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease
- •documented brain metastases unless the patient has completed successful local therapy for central nervous system metastases and has been off of corticosteroids for at least 2 weeks before enrollment
- •significant weight loss (that is, > 10%) over the previous 6 weeks before study entry.
研究组 & 干预措施
A
干预措施: Pemetrexed (Drug)
A
干预措施: Gemcitabine (Drug)
B
干预措施: Pemetrexed (Drug)
B
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Best Overall Tumor Response
时间窗: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
次要结局
- Progression Free Survival(baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up)
- Time to Progressive Disease(baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up)
- Duration of Response(baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up)
- Time to Treatment Failure(baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up)
- Overall Survival(baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up)