Pemetrexed With Simplified Folate and Dexamethasone Supplementation Versus Pemetrexed With Standard Supplementation as Second-line Chemotherapy for Patients With Non-squamous Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Safety: Number of Participants With Drug-Related Grade 3 or 4 Toxicity
研究概览
简要总结
Chemotherapy for patients with non-squamous non-small cell lung cancer. Patients are given folic acid, vitamin B12 and steroids, both before and during treatment, to reduce the side effects associated with pemetrexed. The aim is whether it is possible to simplify the folic acid and steroid schedule without increasing toxicity.
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
- •Histologic or cytologic diagnosis of non-small cell lung cancer (NSCLC) with locally advanced or metastatic disease (Stage IIIA, IIIB or IV)that is of non-squamous histology
- •Patients must have failed only one prior chemotherapy regime and must be considered eligible for further chemotherapy following progression of their disease.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- •Adequate organ function
排除标准
- •Concurrent administration of any other anti-tumor therapy
- •Other co-existing malignancies
- •Pregnancy or breast feeding
- •Serious concomitant disorders
- •Inability or unwillingness to take folic acid or vitamin B12 supplementation
研究组 & 干预措施
Standard Vitamin and Steroid Schedule + Pemetrexed
Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
干预措施: pemetrexed (Drug)
Standard Vitamin and Steroid Schedule + Pemetrexed
Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
干预措施: Folic Acid (Dietary Supplement)
Standard Vitamin and Steroid Schedule + Pemetrexed
Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
干预措施: Vitamin B12 (Dietary Supplement)
Standard Vitamin and Steroid Schedule + Pemetrexed
Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
干预措施: dexamethasone (Drug)
Simplified Vitamin and Steroid Schedule + Pemetrexed
Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
干预措施: pemetrexed (Drug)
Simplified Vitamin and Steroid Schedule + Pemetrexed
Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
干预措施: Folic Acid (Dietary Supplement)
Simplified Vitamin and Steroid Schedule + Pemetrexed
Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
干预措施: Vitamin B12 (Dietary Supplement)
Simplified Vitamin and Steroid Schedule + Pemetrexed
Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
干预措施: dexamethasone (Drug)
结局指标
主要结局
Safety: Number of Participants With Drug-Related Grade 3 or 4 Toxicity
时间窗: From first dose of treatment to last dose of treatment plus 30 days
Results are presented for the number of participants with drug-related Grade 3 or 4 toxicity/adverse event (AE). Grades range from 0 (none) to 5 (death), with Grade 3 and 4 being defined as follows: Grade 0 = No AE; Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. A detailed list of Serious and non-serious adverse events is provided in the Reported Adverse Event section.
次要结局
- Proportion of Participants With Best Overall Tumor Response (Response Rate)(Baseline until disease progression, new therapy initiated, or death from any cause, up to 12 months after enrollment.)
- Overall Survival(Randomization (≤4 weeks from baseline visit) to 12 months after randomization)
- Progression-free Survival (PFS)(Randomization (≤4 weeks from baseline visit) to 12 months after randomization)