NCT00078260已完成3 期
A Randomized Phase 3 Study of Two Doses of Alimta in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed a Prior Platinum-Containing Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 589
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The purposes of this study are to determine:
- the safety of pemetrexed and any side effects that might be associated with it
- how much pemetrexed should be given to patients.
It is possible that information collected during this study will be analyzed by the Sponsor in the future to evaluate pemetrexed for other possible uses or for other medical or scientific purposes other than those currently proposed.
Although pemetrexed has been shown to be effective in some patients with non-small-cell lung cancer, pemetrexed might not have beneficial effects for all 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell lung cancer (NSCLC) that is not amenable to curative therapy.
- •Patients must have been previously treated with one platinum-containing chemotherapy regimen for locally advanced or metastatic disease. Patients are also eligible if they have received one platinum-based chemotherapy regimen as neoadjuvant or adjuvant chemotherapy, but must have received an additional chemotherapy regimen upon recurrence.
- •No more than two prior systemic anti-cancer therapies will be allowed.
- •Prior radiation therapy is allowed to less than 25% of the bone marrow. Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 2 weeks before study enrollment, and the patient must have recovered from the acute toxic effects of the treatment prior to study enrollment.
排除标准
- •Pregnancy.
- •Breast-feeding.
- •Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- •Inability to interrupt aspirin, or other nonsteroidal anti-inflammatory agents for a 5-day period.
- •Inability or unwillingness to take folic acid or vitamin B12 supplementation.
研究组 & 干预措施
B
Experimental
干预措施: pemetrexed (Drug)
A
Experimental
干预措施: pemetrexed (Drug)
结局指标
主要结局
Overall survival
时间窗: baseline to date of death from any cause
次要结局
- Progression free survival(baseline to measured progressive disease)
- Tumor response rate(baseline to measured progressive disease)
- Adverse events(every cycle)
研究者
研究点 (1)
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