Phase II, Randomized, Open-Label Trial of Biweekly Pemetrexed Plus Gemcitabine vs. Pemetrexed or Pemetrexed Plus Carboplatin in Relapsed Non Small Cell Lung Cancer After Neoadjuvant or Adjuvant Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Objective Tumor Response
研究概览
简要总结
The purpose of this study is to help answer:
- Whether pemetrexed, gemcitabine and/or carboplatin can shrink tumor(s) or make tumor(s) disappear in patients with relapsed lung cancer (lung cancer that has come back after surgical removal and chemotherapy), and to determine how long this will last
- Whether pemetrexed, gemcitabine and/or carboplatin can help patients with relapsed lung cancer live longer
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
- •You have non-small cell lung cancer that has come back (relapsed) after initial treatment with surgery and chemotherapy.
- •You have good kidney, liver, and bone marrow organ function.
- •You are fully active or able to carry out light work such as housework or office work.
排除标准
- •You have received pemetrexed or gemcitabine in the past for lung cancer
- •You are currently receiving another treatment for your relapsed lung cancer, or have had chemotherapy or certain other therapies for relapsed lung cancer in the past
- •You are unable to take corticosteroid drugs like dexamethasone
- •You are unable or unwilling to take the folic acid pills or Vitamin B12 injections that are required for the study
- •You are unable to stop taking aspirin or other drugs that control inflammation for certain periods of time during the study
- •You have had a heart attack in the last 6 months, or have other heart problems that are not controlled with medication
研究组 & 干预措施
Less Than One Year: Pemetrexed
Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy
干预措施: Pemetrexed (Drug)
Less Than One Year: Pemetrexed
Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy
干预措施: gemcitabine (Drug)
Less Than One Year: Pemetrexed + Gemcitabine
Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy
干预措施: Pemetrexed (Drug)
One Year or Greater: Pemetrexed + Carboplatin
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy
干预措施: carboplatin (Drug)
One Year or Greater: Pemetrexed + Carboplatin
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy
干预措施: Pemetrexed (Drug)
One Year or Greater: Pemetrexed + Gemcitabine
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy
干预措施: Pemetrexed (Drug)
One Year or Greater: Pemetrexed + Gemcitabine
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy
干预措施: gemcitabine (Drug)
结局指标
主要结局
Objective Tumor Response
时间窗: baseline to time of response (up to 17.5 months)
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
次要结局
- Duration of Response(time of response to progressive disease (up to 17.5 months))
- Time to Progressive Disease(baseline to measured progressive disease (up to 17.5 months))
- Overall Survival(baseline to trial termination (17.5 months))
- Time to Treatment Failure(baseline to stopping treatment (up to 17.5 months))