A Phase 2 Study of ALIMTA in Solid Tumor Patients With Stable Third-Space Fluid
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Overview of Adverse Events
研究概览
简要总结
This study will test the effects of pemetrexed on mesothelioma and non-small cell lung cancer patients with fluid around their lungs or abdomen.
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
- •Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell lung cancer (NSCLC) or mesothelioma
- •Presence of third-space fluid (fluid around the lungs or abdomen).
- •Eastern Cooperative Oncology Group Performance Status of 0 or
- •Prior anticancer treatment (except radiation) must be completed at least 3 weeks prior to study enrollment, and the patient must have recovered from the sharp toxic effects the anticancer treatment.
- •Estimated life expectancy of at least 8 weeks.
排除标准
- •Have received treatment within the last 30 days with a drug that was not a marketed product.
- •Active infection that, in the opinion of the investigator, would not allow the patient to tolerate therapy.
- •Pregnancy.
- •Breast-feeding.
- •Significant weight loss (that is, greater than or equal to 10% of body weight) over the 6 weeks before study entry.
- •Brain metastases.
研究组 & 干预措施
Pemetrexed
Pemetrexed 500 mg/m^2 intravenous (IV) every 21 days for 6 cycles
干预措施: pemetrexed (Drug)
结局指标
主要结局
Overview of Adverse Events
时间窗: baseline, up to 18 weeks
Any untoward medical occurrence in a patient who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
次要结局
- Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities(baseline, up to 18 weeks)
- Pemetrexed Population Pharmacokinetics (PK): Clearance(Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion)
- Pemetrexed Population Pharmacokinetics: Volume of Distribution(Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion)
- Discontinuations Due to Adverse Events(baseline, up to 18 weeks)