NCT00403403已完成2 期
A Placebo-Controlled, Double-Blind, Multicenter, Randomized, Phase II Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
This is a placebo-controlled, double-blind, multicenter, randomized study for preliminary evaluation of the efficacy and safety of combining bevacizumab with cisplatin (or carboplatin) and etoposide in patients with previously untreated extensive-stage small cell lung cancer (SCLC).
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
- 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
- •Histologically or cytologically documented small cell carcinoma of the bronchus, classified as extensive-stage disease
- •Measurable disease or lesions
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
排除标准
- •Life expectancy of < 12 weeks
- •Current, recent, or planned participation in another experimental drug study
- •Ongoing or active infection
- •Active malignancy other than SCLC or superficial basal/squamous cell carcinoma within the previous 5 years
- •Prior systemic therapy, radiation therapy, or surgery for SCLC
- •Inadequate bone marrow function, renal function, or hepatic function
- •Serum sodium of < 120 mg/dL
- •Inadequately controlled hypertension
- •History of hypertensive crisis or hypertensive encephalopathy
- •New York Heart Association Class II or greater congestive heart failure
- •History of myocardial infarction or unstable angina within 6 months prior to study enrollment
- •History of stroke or transient ischemic attack within 6 months prior to study enrollment
- •Known central nervous system disease, except for brain metastases treated with whole-brain radiotherapy
- •Significant vascular disease or recent peripheral arterial thrombosis within 6 months prior to study enrollment
- •History of hemoptysis within 4 weeks prior to study enrollment
- •Evidence of bleeding diathesis or coagulopathy in the absence of therapeutic anticoagulation
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of a need for a major surgical procedure during the course of the study
- •Core biopsy or other minor surgical procedure, including placement of a vascular access device, within 7 days prior to Day 1
- •History of abdominal fistula or gastrointestinal perforation within 6 months prior to study enrollment
- •Serious, non-healing wound, active ulcer, or untreated bone fracture
- •Known hypersensitivity to any component of bevacizumab
- •Pregnant (positive pregnancy test) or lactating
研究组 & 干预措施
Placebo+Chemotherapy
Placebo Comparator
Chemotherapy = cisplatin (or carboplatin) + etoposide
干预措施: Chemotherapy (Drug)
Placebo+Chemotherapy
Placebo Comparator
Chemotherapy = cisplatin (or carboplatin) + etoposide
干预措施: Placebo (Drug)
Bevacizumab+Chemotherapy
Experimental
Chemotherapy = cisplatin (or carboplatin) + etoposide
干预措施: Bevacizumab (Drug)
Bevacizumab+Chemotherapy
Experimental
Chemotherapy = cisplatin (or carboplatin) + etoposide
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Randomization until progression or lost to follow-up (up to 2 years)
Duration of PFS, defined as the time from randomization to disease progression or on-study death, whichever occurred first.
次要结局
- Overall Survival(Randomization until death or lost of follow-up (up to 27 months))
- Percentage of Participants With an Objective Response(Randomization until progression or lost to follow-up (up to 2 years))
- Number of Participants With an Objective Response(Randomization until progression or lost to follow-up (up to 2 years))
- Duration of Objective Response(Randomization until progression or lost to follow-up (up to 2 years))
研究者
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