A Multicenter Randomized Phase II Study of the Combination of Irinotecan/Cisplatin Versus Pemetrexed/Cisplatin as Second-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Overall Response Rate
研究概览
简要总结
This trial will compare the efficacy of irinotecan/cisplatin and pemetrexed/cisplatin in the second-line treatment of patients with stage IIIB/IV NSCLC
详细描述
Non-platinum-based doublets including the newer drugs can be used instead of platinum-based regimens in the first line treatment of patients with advanced NSCLC. Docetaxel or pemetrexed have been proven effective as second-line treatment of patients with NSCLC. In a study conducted by our group the combination of irinotecan/cisplatin demonstrated higher response rates over cisplatin monotherapy in patients progressing after first-line docetaxel/gemcitabine. Moreover, pemetrexed has been combined with the platinums (ie, cisplatin, carboplatin, and oxaliplatin) in NSCLC to yield clinical activity similar to that of other platinum-based doublets. The efficacy of different platinum-based combinations in patients pretreated with non-platinum based first-line chemotherapy is not known.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed NSCLC
- •Age 18 -75 years
- •Performance status (WHO) <2
- •Patients progressing after first-line docetaxel/gemcitabine treatment
- •Adequate bone marrow (absolute neutrophil count >1000/mm3, platelet count >100000/mm3, hemoglobin > 9 gr/ mm3)
- •Adequate liver (bilirubin <1.5 times upper limit of normal), renal (Creatinine clearance > 50mg/min) and cardiac (LVEF >50%) function
- •Presence of measurable disease (according to RESIST criteria)
- •Informed consent
排除标准
- •Psychiatric illness or social situation that would preclude study compliance'
- •Other concurrent uncontrolled illness.
- •Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
研究组 & 干预措施
1
IC
干预措施: Irinotecan (Drug)
1
IC
干预措施: Cisplatin (Drug)
2
PC
干预措施: Cisplatin (Drug)
2
PC
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
次要结局
- Time to Tumor Progression(1-year)
- Overall Survival(1-year)
- Toxicity profile between the two treatment arms(Toxicity assessment on each chemotherapy cycles)
- Quality of life assessment(Assessment every two cycles)