Randomized Phase II Study of Docetaxel and Gemcitabine for Stage IIIB/IV Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 17
- 主要终点
- response rate
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. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of docetaxel plus gemcitabine in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES: I. Evaluate the response rate of patients with stage IIIB or IV nonsmall cell lung cancer to different schedules of docetaxel and gemcitabine therapy. II. Evaluate the toxicity of this treatment in these patients. III. Describe the quality of life parameters of patients receiving this combination therapy. IV. Determine the survival rate of these patients.
OUTLINE: This is a randomized study. Patients are stratified by disease (stage IIIB vs stage IV) and performance status (0 vs 1). Patients are randomized to one of two treatment arms (Arm I now closed). Arm I: Patients receive docetaxel IV over 1 hour on day 1 followed by gemcitabine IV over 30 minutes on days 1, 8, and 15. (closed as of 8/31/1999) Arm II: Patients receive docetaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1 and 15. Arm III: Patients receive docetaxel IV on day 1 and gemcitabine IV on days 1, 8, and 15. Patients continue treatment every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients with either stable disease or complete/partial response who discontinue treatment after 4-6 courses may be eligible for NCCTG-97-24-51. Quality of life is assessed before treatment and before each course of therapy. Patients are followed every 3 months for 1 year, then every 3 months for 5 years.
PROJECTED ACCRUAL: A total of 19-53 patients will be accrued for this study within 6-18 months.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I: docetaxel + gemcitabine
Patients receive docetaxel IV over 1 hour on day 1 followed by gemcitabine IV over 30 minutes on days 1, 8, and 15. Patients continue treatment every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients with either stable disease or complete/partial response who discontinue treatment after 4-6 courses may be eligible for NCCTG-97-24-51.
Quality of life is assessed before treatment and before each course of therapy.
Patients are followed every 3 months for 1 year, then every 3 months for 5 years.
干预措施: docetaxel (Drug)
Arm I: docetaxel + gemcitabine
Patients receive docetaxel IV over 1 hour on day 1 followed by gemcitabine IV over 30 minutes on days 1, 8, and 15. Patients continue treatment every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients with either stable disease or complete/partial response who discontinue treatment after 4-6 courses may be eligible for NCCTG-97-24-51.
Quality of life is assessed before treatment and before each course of therapy.
Patients are followed every 3 months for 1 year, then every 3 months for 5 years.
干预措施: gemcitabine hydrochloride (Drug)
Arm II: docetaxel + gemcitabine
Patients receive docetaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1 and 15. Patients continue treatment every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients with either stable disease or complete/partial response who discontinue treatment after 4-6 courses may be eligible for NCCTG-97-24-51.
Quality of life is assessed before treatment and before each course of therapy.
Patients are followed every 3 months for 1 year, then every 3 months for 5 years.
干预措施: docetaxel (Drug)
Arm II: docetaxel + gemcitabine
Patients receive docetaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1 and 15. Patients continue treatment every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients with either stable disease or complete/partial response who discontinue treatment after 4-6 courses may be eligible for NCCTG-97-24-51.
Quality of life is assessed before treatment and before each course of therapy.
Patients are followed every 3 months for 1 year, then every 3 months for 5 years.
干预措施: gemcitabine hydrochloride (Drug)
Arm III: docetaxel + gemcitabine
Patients receive docetaxel IV on day 1 and gemcitabine IV on days 1, 8, and 15. Patients continue treatment every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients with either stable disease or complete/partial response who discontinue treatment after 4-6 courses may be eligible for NCCTG-97-24-51.
Quality of life is assessed before treatment and before each course of therapy.
Patients are followed every 3 months for 1 year, then every 3 months for 5 years.
干预措施: docetaxel (Drug)
Arm III: docetaxel + gemcitabine
Patients receive docetaxel IV on day 1 and gemcitabine IV on days 1, 8, and 15. Patients continue treatment every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients with either stable disease or complete/partial response who discontinue treatment after 4-6 courses may be eligible for NCCTG-97-24-51.
Quality of life is assessed before treatment and before each course of therapy.
Patients are followed every 3 months for 1 year, then every 3 months for 5 years.
干预措施: gemcitabine hydrochloride (Drug)
结局指标
主要结局
response rate
时间窗: Up to 5 years
次要结局
- quality of life(Up to 5 years)