A Randomized 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
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Number of Patients With Confirmed Responses
研究概览
简要总结
RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed disodium together with gemcitabine may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying two different schedules of pemetrexed disodium and gemcitabine to compare how well they work in treating patients with stage IIIB or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Compare response rates in patients with stage IIIB or IV non-small cell lung cancer treated with two different treatment schedules of pemetrexed disodium and gemcitabine hydrochloride.
Secondary
- Compare time-to-event efficacy variables in patients treated with these regimens.
- Compare progression-free and overall survival of patients treated with these regimens.
- Determine the overall toxicity of these regimens in these patients.
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 120 Years（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
Gemzar x2
Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
干预措施: gemcitabine HCL (Drug)
Gemzar x2
Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
干预措施: pemetrexed disodium (Drug)
Gemzar x1
Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
干预措施: pemetrexed disodium (Drug)
Gemzar x1
Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
干预措施: gemcitabine HCL (Drug)
结局指标
主要结局
Number of Patients With Confirmed Responses
时间窗: Two consecutive evaluations at least 6 weeks apart (up to 2 years)
Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart. \> \> Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.
次要结局
- Overall Survival(Death or last follow-up (up to 2 years))
- Progression-free Survival(Time from registration to progression or death (up to 2 years))
- Adverse Event(Gemzar x2 Arm every 21 days, Gemzar x1 Arm every 14 days (up to 2 years))