A Phase II Randomized Study Of Dose-Dense Docetaxel And Cisplatin Every Two Weeks With Pegfilgrastim And Darbepoetin Alfa With And Without The Chemoprotector BNP7787 In Patients With Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 64
- 主要终点
- Toxicity
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dimesna, may help prevent or decrease the side effects (such as nerve, kidney, and inner ear damage) caused by chemotherapy.
PURPOSE: This randomized phase II trial is studying giving docetaxel and cisplatin together with dimesna to see how well it works compared to giving docetaxel and cisplatin alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Compare the incidence and severity of peripheral neuropathy in patients with stage IIIB or IV non-small cell lung cancer treated with docetaxel and cisplatin with or without dimesna.
- Compare the feasibility of these regimens, in terms of febrile neutropenia and treatment delays, in these patients.
- Compare the objective response rate in patients treated with these regimens.
Secondary
- Compare the survival and failure-free survival of patients treated with these regimens.
- Compare the toxicity profile of these regimens in these patients.
- Compare the incidence and severity of cisplatin-induced nephrotoxicity in patients treated with these regimens.
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 120 Years（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
Chemotherapy without BNP7787
Chemotherapy with dose-dense docetaxel and cisplatin with pegfilgrastim and darbepoetin for pts with NSCLC
干预措施: darbepoetin alfa (Biological)
Chemotherapy without BNP7787
Chemotherapy with dose-dense docetaxel and cisplatin with pegfilgrastim and darbepoetin for pts with NSCLC
干预措施: pegfilgrastim (Biological)
Chemotherapy without BNP7787
Chemotherapy with dose-dense docetaxel and cisplatin with pegfilgrastim and darbepoetin for pts with NSCLC
干预措施: cisplatin (Drug)
Chemotherapy + BNP7787
Chemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787
干预措施: docetaxel (Drug)
Chemotherapy without BNP7787
Chemotherapy with dose-dense docetaxel and cisplatin with pegfilgrastim and darbepoetin for pts with NSCLC
干预措施: docetaxel (Drug)
Chemotherapy + BNP7787
Chemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787
干预措施: darbepoetin alfa (Biological)
Chemotherapy + BNP7787
Chemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787
干预措施: pegfilgrastim (Biological)
Chemotherapy + BNP7787
Chemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787
干预措施: cisplatin (Drug)
Chemotherapy + BNP7787
Chemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787
干预措施: BNP7787 (Drug)
结局指标
主要结局
Toxicity
时间窗: 12 weeks
Toxicity profile w/ emphasis on incidence and severity of peripheral neuropathy, febrile neutropenia, and nephrotoxicity
次要结局
- Survival(q 6 mon for 2 yrs after registration, then annually)
- Response(during tx,q 3 mon for 1 yr, then q 6 mon for 2 yrs)