A Phase III Study of Delayed vs. Immediate Second-Line Therapy With Docetaxel After Gemcitabine + Carboplatin in Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and docetaxel, 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. It is not yet known which treatment regimen is more effective for stage IIIB or stage IV non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine and carboplatin followed immediately by docetaxel with that of giving delayed docetaxel in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Compare the overall survival of patients with stage IIIB or IV non-small cell lung cancer treated with gemcitabine and carboplatin followed by immediate vs delayed docetaxel.
Secondary
- Compare the response rate and time to progression in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life of 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 —（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
Immediate Docetaxel
Arm I (immediate docetaxel): Patients receive immediate docetaxel IV over 1 hour on day 1.
干预措施: carboplatin (Drug)
Immediate Docetaxel
Arm I (immediate docetaxel): Patients receive immediate docetaxel IV over 1 hour on day 1.
干预措施: docetaxel (Drug)
Immediate Docetaxel
Arm I (immediate docetaxel): Patients receive immediate docetaxel IV over 1 hour on day 1.
干预措施: gemcitabine hydrochloride (Drug)
Delayed Docetaxel
Arm II (delayed docetaxel): Patients are observed until first evidence of disease progression and then receive docetaxel IV over 1 hour on day 1.
干预措施: carboplatin (Drug)
Delayed Docetaxel
Arm II (delayed docetaxel): Patients are observed until first evidence of disease progression and then receive docetaxel IV over 1 hour on day 1.
干预措施: docetaxel (Drug)
Delayed Docetaxel
Arm II (delayed docetaxel): Patients are observed until first evidence of disease progression and then receive docetaxel IV over 1 hour on day 1.
干预措施: gemcitabine hydrochloride (Drug)
结局指标
主要结局
Survival
时间窗: Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter
次要结局
- Response rate (partial and complete response)(Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter)
- Time to progression(treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression.)
- Toxicity as measured by NCI CTC(at baseline and at the end of each course not at day 8)
- Quality of life as measured by the lung cancer symptom scale(At baseline, at restaging, before courses 2-6 of docetaxel*, and then at 1 and 3 months after study treatment. Arm II, QOL is assessed every 3 weeks until first disease progression and then before courses 2-6 of docetaxel.)