A Phase II Trial Pemetrexed Carboplatin as First Line Chemotherapy for Advanced Non-Small Cell Lung Cancer (NSCLC) in Elderly Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response)
研究概览
简要总结
A phase II study to evaluate the efficacy and safety profile of the combination of Pemetrexed and Carboplatin in elderly patients with advanced non-small cell lung cancer
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed Non Small Cell Lung Cancer Stage IIIb (not amenable to radiotherapy treatment) or Stage IV
- •No previous chemotherapy for lung cancer
- •Men and women > or = 70 years
- •At least one uni-dimensionally measurable lesion (Response Evaluation Criteria In Solid Tumors [RECIST]criteria)
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
排除标准
- •Treatment within the last 30 days with a drug that has not received regulatory approval
- •Serious systemic disorders
- •Inability to discontinue administration of aspirin or anti-inflammatory non steroid
- •Concurrent administration of any other antitumor therapy
- •Brain metastasis
研究组 & 干预措施
Pemetrexed + Carboplatin
Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.
Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
干预措施: pemetrexed (Drug)
Pemetrexed + Carboplatin
Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.
Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
干预措施: carboplatin (Drug)
结局指标
主要结局
Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response)
时间窗: baseline to measured objective tumor response (up to six 21-day cycles)
Tumor response is defined as the percentage of patients with either a complete response or a partial response. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions and Partial Response=30% decrease in sum of longest diameter of target lesions.
次要结局
- Time to Treatment Failure(baseline to stopping treatment (up to six 21-day cycles))
- Overall Survival(baseline to date of death from any cause (up to 14.5 months))
- Estimated Probability of One Year Progression-free Survival(baseline to measured progressive disease or death, 1 year)