NCT00071136已完成1 期
Phase 1/2 Dose-Escalating Study of Biweekly Alimta and Gemcitabine in Patients With Advanced Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 5
- 主要终点
- To find out how often tumors become smaller or disappear in patients with advanced NSCLC treated with gemcitabine followed by pemetrexed once every 14 days. Chemotherapy treatment will be given for up to 12 times or until the cancer disease increases.
研究概览
简要总结
This is a Phase 2 study of pemetrexed and gemcitabine chemotherapy given once every 14 days to patients with advanced stage non-small cell lung cancer. This treatment is for patients that have not received any prior chemotherapy treatment for lung cancer. The primary goal is to find out if the tumor gets smaller or disappears with this treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Have a diagnosis of advanced stage non-small cell lung cancer.
- •Are able to be active at home and/or work.
- •Have not received chemotherapy for this cancer disease.
- •Have good organ function (for example, most blood work is normal).
- •Have completed any prior radiation treatment at least 4 weeks ago.
排除标准
- •Have been treated with an investigational/research drug within the last month.
- •Have cancer that has spread to the brain and is causing symptoms.
- •Have an active infection or other serious medical condition.
- •Have a second cancer in addition to non-small cell lung cancer.
- •Can not stop taking aspirin or other anti-inflammatory agents for 5-8 days.
结局指标
主要结局
To find out how often tumors become smaller or disappear in patients with advanced NSCLC treated with gemcitabine followed by pemetrexed once every 14 days. Chemotherapy treatment will be given for up to 12 times or until the cancer disease increases.
次要结局
- To measure the effects of chemotherapy treatment on:
- time until the cancer becomes less;time to cancer re-appears or becomes larger;length of time there is no increase in the amount of cancer;length of time patients survive;
- To measure the side-effects from this chemotherapy as given once every 14 days.
研究者
研究点 (5)
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