NCT00365183终止2 期
Phase II Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 74
- 主要终点
- 6 month progression free survival
研究概览
简要总结
The goals of this study are:
- to determine if the combination of two drugs, motexafin gadolinium and pemetrexed, may be an effective treatment for patients with non-small cell lung cancer (NSCLC) who have had one previous chemotherapy regimen that included a platinum containing drug such as cisplatin or carboplatin.
- to assess response to treatment in patients with NSCLC six months after beginning study treatment.
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
- •18 years or older
- •Stage IIIb, metastatic, or recurrent NSCLC patients who have received one prior platinum-based chemotherapy regimen
- •ECOG performance status score of 0 or 1
排除标准
- •Laboratory values indicating inadequate function of bone marrow, liver, or kidneys
- •Symptomatic or uncontrolled brain metastases
- •Evidence of meningeal metastasis
- •> 1 prior regimen (not counting adjuvant or neo-adjuvant cytotoxic chemotherapy if completed > 12 months prior to regiment)
- •Medical condition that would increase risk if treated with motexafin gadolinium or impair ability to complete study procedures and assessments
研究组 & 干预措施
Xcytrin® (motexafin gadolinium)
Experimental
干预措施: Motexafin gadolinium and pemetrexed (Drug)
结局指标
主要结局
6 month progression free survival
时间窗: up to 2 years
proportion of patients who are still alive and who have not progressed clinically or radiographically 6 months after receiving their first dose of MGd.
次要结局
- Duaration of reponse (CR+PR)(up to 2 years)
- Time to disease progression(up to 2 years)
- Overall survival(up to 2 years)
- Safety and tolerability of MGd and pemetrexed(up to 2 years)
- Progression free survival(up to 2 years)
- Response rate (CR+PR) by RECIST criteria(up to 2 years)
- Clinical benefit rate (CR+PR+SD)(up to 2 years)
研究者
相似试验
终止
2 期
Study of the Effect on Non-small Cell Lung Cancer of the Investigational Drug Motexafin Gadolinium When Used in Combination With Docetaxel (Taxotere)Lung CancerNCT00373204Pharmacyclics LLC.50
已完成
2 期
Study of Motexafin Gadolinium for the Treatment of Non-Hodgkin's LymphomaNon-Hodgkin's LymphomaLymphomaNCT00086034Pharmacyclics LLC.35
终止
2 期
Study of Motexafin Gadolinium (MGd) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic LymphomaSmall Lymphocytic LymphomaChronic Lymphocytic LeukemiaNCT00100711Pharmacyclics LLC.27
终止
2 期
A Study of Motexafin Gadolinium for the Treatment of Chronic Lymphocytic Leukemia (CLL)Leukemia, Lymphocytic, ChronicLeukemiaNCT00076401Pharmacyclics LLC.27
终止
1 期
Motexafin Gadolinium With Chemotherapy and Radiation Therapy for the Treatment of Advanced Head and Neck CancerHead and Neck CancerOropharynx CancerLarynx CancerHypopharynx CancerNCT00080028Pharmacyclics LLC.18