NCT00387699已完成2 期
Phase II Trial of Bevacizumab in Combination With Cisplatin/Etoposide and Twice Daily Radiation for Patients With Limited-Stage Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 79
- 主要终点
- Progression-free survival at 1 year
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and help kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab together with cisplatin, etoposide, and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with cisplatin, etoposide, and radiation therapy works in treating patients with limited-stage small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the 1-year progression-free survival of patients with limited-stage small cell lung cancer treated with bevacizumab, cisplatin, etoposide, and radiotherapy.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine the response rate in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed small cell lung cancer (SCLC)
- •Limited-stage disease, defined as SCLC confined to ≥ 1 of the following:
- •One hemithorax
- •Ipsilateral supraclavicular fossa
- •Measurable disease
- •No malignant pleural effusion, contralateral hilar disease, or contralateral supraclavicular disease
- •Minimal pleural effusion visible on CT scan of the chest, but not evident on chest x-ray, allowed
- •No completely surgically resected disease
- •No CNS disease, including primary brain tumor or brain metastasis
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Absolute granulocyte count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Bilirubin ≤ 1.5 mg/dL
- •Creatinine ≤ 1.5 mg/dL
- •Urine protein:creatinine ratio ≤ 0.5 OR 24-hour urine protein < 1,000 mg
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
- •INR ≤ 1.5 (unless on full-dose anticoagulants)
- •No active serious infection
- •No serious or nonhealing wound
- •No ulcer or bone fracture
- •No evidence of bleeding diatheses or coagulopathy
- •No hemoptysis
- •No known hypersensitivity to Chinese hamster ovary cell products and/or other recombinant human antibodies
- •No clinically significant cardiovascular disease, including any of the following:
- •Uncontrolled hypertension
- •New York Heart Association class II-IV congestive heart failure
- •Serious cardiac arrhythmia requiring medication
- •Unstable angina pectoris
- •Symptomatic peripheral vascular disease
- •Cerebrovascular accident within the past 6 months
- •Symptomatic heart disease within the past 6 months
- •Myocardial infarction within the past 6 months
- •Unstable angina within the past 6 months
- •No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 4 weeks
- •No significant traumatic injury within the past 4 weeks
- •PRIOR CONCURRENT THERAPY:
- •At least 4 weeks since prior major surgery or open biopsy
- •At least 1 week since prior core biopsy
- •No prior chemotherapy or radiotherapy for small cell lung cancer
- •No concurrent major surgery
- •No concurrent palliative local radiotherapy
- •No concurrent intensity-modulated radiotherapy
- •Concurrent full-dose anticoagulants (e.g., warfarin) allowed provided all of the following criteria are met:
- •In-range INR (2-3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
- •No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
排除标准
- 未提供
结局指标
主要结局
Progression-free survival at 1 year
次要结局
- Response rate
- Toxicity
研究者
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