A Phase III Randomized, Double Blind, Placebo Controlled Trial Of Carboplatin/Etoposide With Or Without Thalidomide In Small Cell Lung Cancer (Study 12)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 724
- 试验地点
- 1
- 主要终点
- Survival at 2 years after study randomization
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy such as carboplatin and etoposide use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if combination chemotherapy is more effective with or without thalidomide in treating small cell lung cancer.
PURPOSE: This randomized phase III trial is studying carboplatin, etoposide, and thalidomide to see how well they work compared to carboplatin and etoposide in treating patients with limited- or extensive-stage small cell lung cancer.
详细描述
OBJECTIVES:
- Compare the survival of patients with limited or extensive stage small cell lung cancer treated with carboplatin and etoposide with vs without thalidomide.
- Compare the time to disease progression in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the response rates of patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (limited vs extensive), ECOG performance status (0 and 1 vs 2), and alkaline phosphatase (no greater than 1.5 times upper limit of normal [ULN] vs greater than 1.5 times ULN). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive carboplatin IV over 30 minutes on day 1 and etoposide* IV over 1-2 hours on days 1 and 2 and orally on day 3. Patients also receive oral thalidomide daily beginning on day 1.
- Arm II: Patients receive carboplatin and etoposide as in arm I and oral placebo daily beginning on day 1.
NOTE: *Patients who are unable to receive etoposide IV on day 2 may receive oral etoposide on days 2 and 3.
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
- Triple (Participant, Care Provider, 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
Active arm (thalidomide)
Carboplatin IV on day 1 and etoposide IV on day 1 and 2 and, orally Day 3. Oral thalidomide daily beginning on day 1 for up to 24 months.
干预措施: Carboplatin, etoposide & thalidomide (Drug)
Placebo arm
Carboplatin IV on day 1 and etoposide IV on day 1 and 2 and, orally Day 3. Oral placebo daily beginning on day 1 for up to 24 months.
干预措施: Carboplatin, etoposide & placebo (Drug)
结局指标
主要结局
Survival at 2 years after study randomization
时间窗: 0-2 years
次要结局
- Time to disease progression 2 years after study randomization(0-2 years)
- Toxicity as measured by NCIC CTC 3 times weekly while undergoing chemotherapy, then monthly thereafter(Till end of treatment)
- Response rates as measured by RECIST during each visit while undergoing chemotherapy and after completion of study treatment(Till progression)
- Quality of life as measured by EORTC QLQ-30 and lung-specific questionnaire(LC14) at baseline, after each course, and after completion of study treatment, and at 6, 12, 18, and 24 months after day 1 of course 1(0-24 months)
- Biological markers (measurement of VEGF, bFGF, TNF alpha, and IL-6)(Before treatment courses 1 and 4, and then at 9 and 18 months)