NCT00309998已完成2 期
Vinorelbine Plus Bevacizumab as First Line Therapy in Patients ≥ 70 Years of Age With Stage IIIB/IV Non-Squamous, Non-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
- 50
- 试验地点
- 1
- 主要终点
- Median time to disease progression by imaging study every 6 weeks
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving vinorelbine together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving vinorelbine together with bevacizumab works in treating older patients with stage III or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Estimate the median time to disease progression in older patients with non-squamous stage IIIB or stage IV non-small cell lung cancer (NSCLC) treated with vinorelbine ditartate and bevacizumab.
Secondary
- Estimate the response rate in patients treated with this regimen.
- Estimate the median survival in patients treated with this regimen.
- Evaluate the safety of the combination of vinorelbine ditartate and bevacizumab in older patients.
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
- 70 Years 至 120 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed non-squamous, non-small cell lung cancer (NSCLC)
- •Stage IIIB (any T, N3, M0 OR T4, any N, M0, OR pleural effusion) OR stage IV (any T, any N, M1) disease
- •Mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible
- •Measurable or evaluable disease
- •No lung carcinoma of squamous cell histology or any histology in close proximity to a major vessel or cavitation
- •No known brain metastases, even if treated
- •PATIENT CHARACTERISTICS:
- •No other malignancies within the past 5 years except nonmelanoma skin cancer
- •ECOG performance status 0-1
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Bilirubin ≤ 1.5 mg/dL
- •Transaminases ≤ 5 times upper limit of normal (ULN)
- •Creatinine ≤ 1.5 times ULN
- •Urine protein:creatinine ratio < 1
- •INR ≤ 1.5
- •PTT normal
- •No prior ileus or neuropathy compromising use of vinorelbine ditartate
- •Patients with a history of hypertension must be well controlled (blood pressure < 150/100 mm Hg) on a stable regimen of antihypertensive therapy
- •None of the following conditions:
- •Unstable angina
- •New York Heart Association grade II-IV congestive heart failure
- •Myocardial infarction within the past 6 months
- •Stroke within the past 6 months
- •Evidence of bleeding diathesis or coagulopathy
- •Clinically significant peripheral vascular disease
- •Serious, nonhealing wound, ulcer, or bone fracture
- •History of hemoptysis (bright red blood ≥ ½ teaspoon)
- •No significant traumatic injury within the past 4 weeks
- •No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •No prior chemotherapy for NSCLC
- •More than 4 weeks since prior and no concurrent participation in another experimental drug study
- •More than 4 weeks since prior immunotherapy, hormonal therapy, or radiotherapy and recovered
- •More than 28 days since prior major surgical procedure or open biopsy
- •No anticipation of need for major surgery during course of trial
- •More than 7 days since prior minor surgical procedures (e.g., fine-needle aspiration or core biopsy)
- •No concurrent full-dose anticoagulation therapy for thromboembolic disease, aspirin (> 325 mg/day), or nonsteroidal anti-inflammatory drugs
排除标准
- 未提供
结局指标
主要结局
Median time to disease progression by imaging study every 6 weeks
次要结局
- Safety as measured by toxicity (e.g thromboembolism, bleeding, or bowel perforation) every three weeks or as required
- Response rate by imaging study every 6 weeks
- Median survival
研究者
研究点 (1)
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