NCT00447421终止1 期
Phase I/II Study of Concurrent Cisplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Phase 1: Maximum Tolerated Dose
研究概览
简要总结
The purpose of this study is to determine the recommended dose of pemetrexed, cisplatin and radiotherapy in the treatment of patients with 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Measurable disease with diagnosis of Small Cell Lung Cancer.
- •Performance status of 0 to 1 on the Eastern Cooperative Oncology Group performance status schedule.
- •Patients must be at least 18 years of age and have at least a 12-week life expectancy.
- •No prior chemotherapy and/or prior thoracic radiotherapy.
- •Adequate pulmonary function and organ function.
排除标准
- •Patients with myocardial infarction within the preceding six months.
- •Diagnosis of a serious concomitant systemic disorder.
- •Prior radiotherapy to the lower neck or abdominal region.
- •Significant weight loss.
- •Concurrent administration of any other antitumor therapy.
研究组 & 干预措施
A
Experimental
干预措施: pemetrexed (Drug)
A
Experimental
干预措施: cisplatin (Drug)
A
Experimental
干预措施: radiation (Radiation)
结局指标
主要结局
Phase 1: Maximum Tolerated Dose
时间窗: every cycle
Phase 2: Overall Response Rate
时间窗: baseline to measured progressive disease
Overall Response Rate (ORR) was defined as the proportion of participants having either a Complete or Partial response 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.
次要结局
- Phase 1: Best Overall Response(baseline to measured response)
- Phase 2: Complete Response Rate(baseline to measured response time)
- Phase 2: Time to Progressive Disease(baseline to measured progressive disease)
- Phase 2: Duration of Response(time of response to progressive disease)
- Phase 2: Overall Survival(baseline to date of death from any cause)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
1 期
Concurrent Pemetrexed/Cisplatin With Pleural Intensity Modulated Radiation Therapy for Patients With Unresectable Malignant Pleural MesotheliomaMalignant Pleural MesotheliomaNCT02639767Memorial Sloan Kettering Cancer Center
已完成
1 期
Cisplatin, Pemetrexed, and Imatinib Mesylate in Malignant MesotheliomaMesotheliomaNCT00402766M.D. Anderson Cancer Center19
终止
2 期
Pemetrexed and Cisplatin as Treatment in Small Cell Lung CancerSmall Cell Lung CancerNCT00475657Eli Lilly and Company5
Unknown
1 期
Study of Concurrent Pemetrexed, Cisplatin and Radiotherapy in Local Advanced Non-Small Cell Lung CancerLocal Advanced Non-Small Cell Lung CancerNCT00846443Fudan University12
已完成
2 期
A Study of Pemetrexed and Cisplatin, in Non Small Cell Lung CancerNon Small Cell Lung CancerNCT01000480Eli Lilly and Company90