Phase II Trial of Pemetrexed Disodium and Carboplatin in Previously Untreated Extensive Stage Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 148
- 主要终点
- Proportion of confirmed-tumor response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving pemetrexed disodium together with carboplatin works in treating patients with extensive-stage small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the complete and partial response rates in patients with previously untreated, extensive-stage small cell lung cancer treated with pemetrexed disodium and carboplatin.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine, preliminarily, the survival of patients treated with this regimen.
- Determine, preliminarily, the response rate in patients 70 years and older treated with this regimen.
- Determine, preliminarily, the toxicity of this regimen in patients 70 years and older.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
pemetrexed + carboplatin + radiation
Patients receive pemetrexed disodium IV over 10 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who develop progressive disease in the CNS only may receive whole-brain radiotherapy and then continue chemotherapy after completion of whole-brain radiotherapy for up to 6 courses.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 4 years.
干预措施: carboplatin (Drug)
pemetrexed + carboplatin + radiation
Patients receive pemetrexed disodium IV over 10 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who develop progressive disease in the CNS only may receive whole-brain radiotherapy and then continue chemotherapy after completion of whole-brain radiotherapy for up to 6 courses.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 4 years.
干预措施: pemetrexed disodium (Drug)
pemetrexed + carboplatin + radiation
Patients receive pemetrexed disodium IV over 10 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who develop progressive disease in the CNS only may receive whole-brain radiotherapy and then continue chemotherapy after completion of whole-brain radiotherapy for up to 6 courses.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 4 years.
干预措施: radiation (Radiation)
结局指标
主要结局
Proportion of confirmed-tumor response
时间窗: Up to 5 years
次要结局
未报告次要终点