NCT00334763终止2 期
Phase II Study of Radiation Followed by Paclitaxel, Carboplatin, and Bevacizumab (PCA) in Patients With Stage IIIB and IV Squamous Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 10
- 主要终点
- Reduction in toxicity measured by pulmonary hemorrhage rate
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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 radiation therapy together with chemotherapy and monoclonal antibody therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving radiation therapy together with chemotherapy and bevacizumab works in treating patients with recurrent, unresectable or stage III or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate reduction in toxicity, in terms of pulmonary hemorrhage, in patients with recurrent, unresectable or stage IIIB or IV squamous non-small cell lung cancer treated with radiotherapy followed by paclitaxel, carboplatin, and bevacizumab.
Secondary
- Determine the overall and progression-free survival of 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 non-small cell lung cancer (NSCLC)
- •Predominantly squamous cell histology
- •Cytologic or histologic elements can be established on metastatic tumor aspirates or biopsy
- •Advanced disease, meeting 1 of the following staging criteria:
- •Stage IIIB disease with malignant pleural effusion
- •Stage IV disease
- •Recurrent, unresectable disease
- •Measurable or nonmeasurable disease
- •No extrathoracic only disease
- •No known CNS metastases by head CT scan with contrast or MRI
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Platelet count > 100,000/mm^3
- •Absolute neutrophil count > 1,500/mm^3
- •Bilirubin < 1.5 mg/dL
- •Transaminases < 5 times upper limit of normal (ULN)
- •Creatinine clearance ≥ 45 mL/min
- •Urine protein:creatinine ratio ≤ 1.0 by spot urinalysis
- •INR < 1.5 ULN
- •PTT normal
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients use effective contraception
- •No serious nonhealing wound, ulcer, or bone fracture
- •No ongoing or active infection
- •No ongoing fever
- •No myocardial infarction within the past 6 months
- •No stroke within the past 6 months
- •No history of hypertension unless well-controlled (i.e., blood pressure < 150/100 mmHg on a stable regimen of antihypertensive therapy)
- •No New York Heart Association grade III or IV congestive heart failure
- •No serious cardiac arrhythmia requiring medication
- •No unstable angina pectoris
- •No peripheral vascular disease ≥ grade 2
- •No other clinically significant cardiovascular disease
- •No abdominal fistula
- •No gastrointestinal perforation
- •No intra-abdominal abscess within the past 6 months
- •No psychiatric illness or social situation that would preclude study compliance
- •No other malignancy curatively treated within the past 5 years
- •No history of thrombotic or hemorrhagic disorders
- •No gross hemoptysis (i.e., red blood ≥ ½ teaspoon) within the past 3 months
- •No bleeding requiring intervention or ≥ grade 2
- •PRIOR CONCURRENT THERAPY:
- •Recovered from prior therapy
- •No prior systemic chemotherapy for metastatic NSCLC
- •More than 6 months since prior adjuvant chemotherapy for early stage (i.e., stage IB-IIIA) NSCLC
- •More than 3 weeks since prior immunotherapy, hormonal therapy, or radiotherapy
- •More than 28 days since prior and no concurrent major surgery
- •More than 7 days since prior minor surgery, fine-needle aspiration, or core biopsy
- 另有 5 项未显示
排除标准
- 未提供
结局指标
主要结局
Reduction in toxicity measured by pulmonary hemorrhage rate
次要结局
- Overall survival by Kaplan-Meier
- Response rate
- Toxicity
研究者
研究点 (10)
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