Phase II Study of First-Line Therapy With Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
This study is designed to study the role of an active and well-tolerated non-platinum agent, gemcitabine, in a combination regimen with pemetrexed in the first-line treatment of advanced NSCLC. This study will serve to define the role of next generation agents in a new combination regimen in the treatment of advanced NSCLC. This combination regimen may ultimately be important in further expanding treatment options for patients while improving survival, quality of life, and symptom control compared with platinum-based combination regimens - and with acceptable toxicity.
详细描述
Upon determination of eligibility, patients will be receive:
- Pemetrexed + Gemcitabine
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •To be included in this study, you must meet the following criteria:
- •Histologically confirmed non-small cell bronchogenic carcinoma
- •Newly diagnosed or recurrent unresectable stage III or stage IV disease
- •No mixed tumors with small cell anaplastic elements
- •Measurable disease
- •Must not have received any prior antineoplastic chemotherapy for lung cancer
- •Age > 18 years
- •Able to perform activities of daily living with little or no assistance
- •Adequate bone marrow, liver and kidney
- •Understand the nature of this study and give written informed consent.
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •Female patients who are pregnant or are lactating
- •History of serious cardiovascular disease within the previous six months
- •Serious active infection at the time of treatment
- •Other serious underlying medical condition
- •Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
研究组 & 干预措施
Intervention
Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
干预措施: Pemetrexed (Drug)
Intervention
Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: 18 months
Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.
次要结局
- Progression-free Survival (PFS)(18 months)
- Overall Survival (OS)(18 months)