NCT00191620已完成2 期
Randomized Phase II Study of Cisplatin + Gemcitabine Administered Either as Short Infusion or at a Fixed Dose Rate in Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 4
- 主要终点
- To evaluate the objective response rate (ORR) of the standard (30 minute infusion) versus a fixed dose rate (10 mg/m2/minute) of gemcitabine combined with cisplatin as treatment for advanced NSCLC after treatment completion.
研究概览
简要总结
The purposes of this study are to determine:
How standard gemcitabine plus cisplatin compares to fixed dose rate of gemcitabine plus cisplatin in the treatment of non-small cell lung cancer.
The safety of standard gemcitabine plus cisplatin and any side effects that might be associated with it as compared to a fixed dose rate of gemcitabine plus cisplatin.
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
- •At least 18 years of age
- •Histologically or cytologically confirmed diagnosis of NSCLC
- •Have provided written informed consent
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Adequate organ function
排除标准
- •Prior chemotherapy or biologic therapy (approved or experimental) for NSCLC
- •Presence of uncontrolled central nervous system (CNS) metastases
- •Inability to comply with protocol or study procedures
- •Pregnancy
- •Breast feeding
结局指标
主要结局
To evaluate the objective response rate (ORR) of the standard (30 minute infusion) versus a fixed dose rate (10 mg/m2/minute) of gemcitabine combined with cisplatin as treatment for advanced NSCLC after treatment completion.
次要结局
- To evaluate progression-free survival of the standard versus a fixed dose rate of gemcitabine combined with cisplatin as treatment for advanced NSCLC.
- To evaluate incidence of laboratory and non laboratory adverse events by maximum Common Toxicity Criteria (CTC) toxicity grade and relationship to study drug of the standard versus a fixed dose rate of gemcitabine combined with cisplatin as treatment for
研究者
研究点 (4)
Loading locations...
相似试验
已完成
2 期
Gemcitabine/Cisplatin Versus Gemcitabine/Epirubicin for Non-Small Cell Lung Cancer (NSCLC)Non-Small Cell Lung CancerNCT00154739National Taiwan University Hospital86
终止
2 期
Randomized Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary CancerMetastatic Biliary Tract CancerLocally Advanced Biliary Tract CancerNCT01096745Gyeongsang National University Hospital78
已完成
2 期
Randomized Phase 2 Study With Gemcitabine Alone and Combination Therapy for Patients With Advanced Biliary Tract CancerBiliary Tract CancerNCT00380588Eli Lilly and Company84
已完成
2 期
Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial CancerEndometrial CancerNCT00388154M.D. Anderson Cancer Center21
已完成
2 期
Study of Gemcitabine and Cisplatin With or Without Cetuximab in Urothelial CancerBladder CancerNCT00645593University of Michigan Rogel Cancer Center89