NCT00191750已完成2 期
Phase II Trial of ALIMTA in Relapsed Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- To assess the antitumor activity for patients with both sensitive and refractory small cell lung cancer patients as measured by tumor response rate. To characterize the toxicities of pemetrexed in this patient population
研究概览
简要总结
The purposes of this study are to determine 1) the safety of pemetrexed and any side effects that might be associated with it 2) whether pemetrexed can help patients with small cell lung cancer live longer 3) whether pemetrexed can make tumors smaller or disappear and for how long and 4) to see if patients feel better while taking pemetrexed
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
- •Diagnosis of small cell lung cancer
- •One prior treatment with chemotherapy or immunotherapy with greater than 3 weeks since the prior treatment
- •At least 18 years of age
- •Estimated life expectancy of at least 12 weeks
- •Ambulatory and capable of self-care(eg, up and about greater than 50% of waking hours)
排除标准
- •Have received treatment within the last 30 days with a drug that has not received FDA approval for any indication
- •Less than 2 weeks from radiation therapy
- •Other serious illness that would compromise the safety of the patient
- •Most second primary malignancies treated less than 5 years previously
结局指标
主要结局
To assess the antitumor activity for patients with both sensitive and refractory small cell lung cancer patients as measured by tumor response rate. To characterize the toxicities of pemetrexed in this patient population
次要结局
- To better understand any side effects of pemetrexed
研究者
研究点 (3)
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