Docetaxel In Second-Line Treatment Of Advanced Non-Small-Cell Lung Cancer - The Distal Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 28
- 主要终点
- Quality of life
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective in treating non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare two different docetaxel regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
- Compare the quality of life of patients with stage IIIB or IV non-small cell lung cancer treated with 2 different schedules of docetaxel as second-line therapy.
- Compare the toxicity of these regimens in these patients.
- Compare the response rate, time to progression, and survival of these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, ECOG performance status (0 vs 1 vs 2), response to prior chemotherapy (partial or complete response vs stable disease vs progressive disease), and prior cisplatin-containing chemotherapy regimen (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive docetaxel IV on day 1. Treatment continues every 3 weeks for a maximum of 6 courses.
- Arm II: Patients receive docetaxel IV weekly for 6 weeks. Treatment continues every 8 weeks for a maximum of 2 courses.
Quality of life is assessed at baseline and days 22 and 43-56 for arm I, and at baseline and days 22 and 43 for arm II.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer (NSCLC)
- •Metastatic supraclavicular lymphadenopathy or malignant pleural effusion
- •Progressive disease
- •Must have received prior chemotherapy
- •No symptomatic brain metastases
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 2,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Bilirubin no greater than 1.25 times upper limit of normal (ULN) AST and ALT no greater than 1.25 times ULN
- •Creatinine no greater than 1.25 times ULN
- •Cardiovascular:
- •No prior or concurrent cardiovascular disease that would preclude study
- •See Disease Characteristics
- •No prior or concurrent pulmonary disease that would preclude study
- •No prior or other concurrent illness or medical condition that would preclude study
- •No other prior malignancy except adequately treated carcinoma in situ of the cervix or nonmelanomatous skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •No prior docetaxel
- •At least 3 weeks since other prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Prior radiotherapy allowed
- •No concurrent radiotherapy
- •Prior radical surgery for NSCLC allowed
- •Concurrent palliative surgery allowed
排除标准
- 未提供
结局指标
主要结局
Quality of life
Toxicity
Response rate
Time to progression
Survival
次要结局
未报告次要终点