Docetaxel And Infliximab/Placebo In Non-Small Cell Lung Cancer (NSCLC) Patients Greater Than Or Equal To 65 Years Of Age Or In NSCLC Patients With Poor Performance Status: A Double-Blind Randomized, Placebo-Controlled Trial To Prevent And Treat Wasting, Anorexia, And Asthenia In Chemotherapy-Naive And Previously-Treated Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 187
- 主要终点
- Assessment of weight
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Infliximab may improve cancer-related weight loss, lack of appetite, and fatigue. It is not yet known whether docetaxel is more effective with or without infliximab in preventing weight loss and fatigue in patients with advanced cancer. (Infliximab treatment discontinued effective 10/05/05)
PURPOSE: Randomized phase III trial to determine the effectiveness of docetaxel with or without infliximab in preventing weight loss, loss of appetite, and fatigue in patients who have unresectable non-small cell lung cancer. (Infliximab treatment discontinued effective 10/05/05)
详细描述
OBJECTIVES:
- Compare the improvement or stabilization of weight in elderly or poor performance status patients with unresectable non-small cell lung cancer treated with docetaxel with or without infliximab (infliximab treatment discontinued effective 10/05/05).
- Compare appetite and functional status in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the augmentation or maintenance of lean tissue in patients treated with these regimens.
- Compare the response rates and time to disease progression in patients treated with these regimens.
- Compare the survival of patients treated with these regimens.
- Determine whether the tumor necrosis factor-alpha polymorphisms in the -308 and -238 regions predict which cancer patients will experience loss of appetite and weight and which patients might potentially benefit from infliximab (infliximab treatment discontinued effective 10/05/05).
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to weight loss within the past 6 months (0% vs more than 0% to less than 5% vs at least 5%), number of prior chemotherapy regimens (0 vs 1 vs more than 1), gender, and GBU prognostic index (good vs bad vs unsure).
- Part A (non-randomized, single-center portion of study): Five patients receive infliximab IV (infliximab treatment discontinued effective 10/05/05) over 2 hours once weekly on weeks 1, 3, and 5 of the first course and once weekly on weeks 1 and 5 of all subsequent courses and docetaxel IV over 1 hour (immediately after completion of infliximab infusion [infliximab treatment discontinued effective 10/05/05]) once weekly on weeks 1-6 of each course. Treatment repeats every 8 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity.
If none of the 5 patients experiences any grade 4 or 5 toxicity directly attributable to infliximab (infliximab treatment discontinued effective 10/05/05), additional patients are accrued for part B of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
infliximab + docetaxel
Patients receive infliximab IV over 2 hours once weekly on weeks 1, 3, and 5 of the first course and once weekly on weeks 1 and 5 of all subsequent courses and docetaxel IV over 1 hour (immediately after completion of infliximab infusion once weekly on weeks 1-6 of each course.
Treatment repeats every 8 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity.
Quality of life, fatigue, appetite/anorexia, cachexia, and weight are assessed at baseline, weekly on weeks 1-8, and then monthly for the remainder of study treatment.
Patients are followed every 6 months for 5 years.
干预措施: infliximab (Biological)
infliximab + docetaxel
Patients receive infliximab IV over 2 hours once weekly on weeks 1, 3, and 5 of the first course and once weekly on weeks 1 and 5 of all subsequent courses and docetaxel IV over 1 hour (immediately after completion of infliximab infusion once weekly on weeks 1-6 of each course.
Treatment repeats every 8 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity.
Quality of life, fatigue, appetite/anorexia, cachexia, and weight are assessed at baseline, weekly on weeks 1-8, and then monthly for the remainder of study treatment.
Patients are followed every 6 months for 5 years.
干预措施: docetaxel (Drug)
placebo + docetaxel
Patients receive docetaxel IV over 1 hour (immediately after completion of infliximab infusion once weekly on weeks 1-6 of each course. Patients receive placebo IV over 2 hours once weekly on weeks 1, 3, and 5 of the first course and once weekly on weeks 1 and 5 of all subsequent courses.
Treatment repeats every 8 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity.
Quality of life, fatigue, appetite/anorexia, cachexia, and weight are assessed at baseline, weekly on weeks 1-8, and then monthly for the remainder of study treatment.
Patients are followed every 6 months for 5 years.
干预措施: docetaxel (Drug)
placebo + docetaxel
Patients receive docetaxel IV over 1 hour (immediately after completion of infliximab infusion once weekly on weeks 1-6 of each course. Patients receive placebo IV over 2 hours once weekly on weeks 1, 3, and 5 of the first course and once weekly on weeks 1 and 5 of all subsequent courses.
Treatment repeats every 8 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity.
Quality of life, fatigue, appetite/anorexia, cachexia, and weight are assessed at baseline, weekly on weeks 1-8, and then monthly for the remainder of study treatment.
Patients are followed every 6 months for 5 years.
干预措施: placebo (Other)
结局指标
主要结局
Assessment of weight
时间窗: Up to 5 years
Rate of weight change
时间窗: Up to 5 years
次要结局
- Overall survival(Up to 5 years)
- Cancer-related fatigue as measured by the Brief Fatigue Inventory(Up to 5 years)
- Quality of life(Up to 5 years)
- Incidence of treatment-related toxicity(Up to 5 years)
- Appetite(Up to 5 years)
- Lean tissue changes(Up to 5 years)
- Time-to-weight decline(Up to 5 years)