A Safety and Feasibility Study of Bevacizumab With Paclitaxel, Carboplatin and Chest Radiotherapy in Patients With Locally Advanced Non-Small Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Safety and feasibility
研究概览
简要总结
This phase I trial studies how well giving bevacizumab together with paclitaxel, carboplatin, and radiation therapy to the chest works in treating patients with locally advanced non-small cell lung cancer. 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. 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab together with paclitaxel, carboplatin, and radiation therapy may kill more tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. Assess the feasibility of administering bevacizumab, paclitaxel, carboplatin, and chest radiotherapy in patients with locally advanced non-small cell lung cancer.
II. Characterize the toxicity of this treatment regimen. III. Assess the clinical response to this treatment regimen. IV. Correlate circulating levels of angiopoietin-2 and vascular endothelial growth factor receptor-2 with clinical response to this treatment regimen.
OUTLINE: This is an open-label, multicenter study.Induction therapy.
Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, 36, and 43 and bevacizumab IV over 30-90 minutes on days 1, 15, 29, and 43. Patients also undergo chest radiotherapy 5 days a week for 7 weeks beginning on day 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically or cytologically confirmed non-small cell lung carcinoma (NSCLC) meeting the following criteria:
- •The following subtypes are eligible:
- •Adenocarcinoma (including bronchoalveolar)
- •Large cell carcinoma (including giant and clear cell carcinomas)
- •Poorly differentiated carcinoma
- •No squamous cell histology
- •Unresectable stage II-III disease
- •Tumor must not invade the trachea or major arterial or venous structures
- •Measurable or evaluable disease
- •Measurable disease defined as ? 1 lesion that can be accurately measured in ? 1 dimension as ? 20 mm with conventional techniques or as ? 10 mm with spiral CT scan
- •No evidence of CNS disease, including primary brain tumor or brain metastases
- •ECOG performance status (PS) 0-1 or Karnofsky PS 60-100%
- •Life expectancy > 6 months
- •Granulocyte count ? 1,500/mm³
- •Platelet count ? 100,000/mm³
- •Bilirubin < 1.25 times upper limit of normal (ULN)
- •AST < 2.5 times ULN
- •Creatinine normalOR creatinine clearance ? 60 mL/min
- •FEV_1 ? 1.0 liters
- •24-hour urine protein < 1,000 mg (for patients with urine protein:creatinine ratio [by urine analysis] > 1.0)
- •No hemoptysis within the past 12 months (defined as bright red blood in sputum of > 1 teaspoon)
- •No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- •No history of allergic reactions attributed to carboplatin or taxane
- •No serious or nonhealing wound, ulcer, or bone fracture
- •No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
- •No significant traumatic injury within the past 14 days
- •No clinically significant cardiovascular disease, including any of the following:
- •Cerebrovascular accident within the past 6 months
- •Uncontrolled hypertension
- •Myocardial infarction or unstable angina within the past 6 months
- •New York Heart Association class II-IV congestive heart failure
- •Serious cardiac arrhythmia requiring medication
- •Unstable angina pectoris
- •Clinically significant peripheral vascular disease
- •No known bleeding diathesis or coagulopathy
- •No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
- •No uncontrolled intercurrent illness including, but not limited to, the following:
- •Ongoing or active infection
- •Psychiatric illness or social situations that would limit study compliance
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for ? 6 months after completion of study treatment
- •No HIV positivity
- •No prior chemotherapy
- •No prior epidermal growth factor receptor-targeted therapy
- •No prior vascular endothelial growth factor-targeted therapy
- •No prior chest radiotherapy
- •No major surgery or open biopsy within the past 14 days
- •No concurrent treatment with full-dose anticoagulation
- •Low-dose anticoagulants (e.g., warfarin) to maintain patency of central venous catheter allowed provided all of the following criteria are met:
- 另有 8 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (paclitaxel, carboplatin, bevacizumab, radiation)
Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, 36, and 43 and bevacizumab IV over 30-90 minutes on days 1, 15, 29, and 43. Patients also undergo chest radiotherapy 5 days a week for 7 weeks beginning on day 1.
Consolidation therapy: Beginning 4-5 weeks after completion chemoradiotherapy, patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 1 hour followed by bevacizumab IV over 30 minutes. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
干预措施: 3-dimensional conformal radiation therapy (Radiation)
Treatment (paclitaxel, carboplatin, bevacizumab, radiation)
Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, 36, and 43 and bevacizumab IV over 30-90 minutes on days 1, 15, 29, and 43. Patients also undergo chest radiotherapy 5 days a week for 7 weeks beginning on day 1.
Consolidation therapy: Beginning 4-5 weeks after completion chemoradiotherapy, patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 1 hour followed by bevacizumab IV over 30 minutes. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
干预措施: paclitaxel (Drug)
Treatment (paclitaxel, carboplatin, bevacizumab, radiation)
Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, 36, and 43 and bevacizumab IV over 30-90 minutes on days 1, 15, 29, and 43. Patients also undergo chest radiotherapy 5 days a week for 7 weeks beginning on day 1.
Consolidation therapy: Beginning 4-5 weeks after completion chemoradiotherapy, patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 1 hour followed by bevacizumab IV over 30 minutes. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
干预措施: bevacizumab (Biological)
Treatment (paclitaxel, carboplatin, bevacizumab, radiation)
Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, 36, and 43 and bevacizumab IV over 30-90 minutes on days 1, 15, 29, and 43. Patients also undergo chest radiotherapy 5 days a week for 7 weeks beginning on day 1.
Consolidation therapy: Beginning 4-5 weeks after completion chemoradiotherapy, patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 1 hour followed by bevacizumab IV over 30 minutes. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
干预措施: carboplatin (Drug)
Treatment (paclitaxel, carboplatin, bevacizumab, radiation)
Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, 36, and 43 and bevacizumab IV over 30-90 minutes on days 1, 15, 29, and 43. Patients also undergo chest radiotherapy 5 days a week for 7 weeks beginning on day 1.
Consolidation therapy: Beginning 4-5 weeks after completion chemoradiotherapy, patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 1 hour followed by bevacizumab IV over 30 minutes. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Safety and feasibility
时间窗: Up to 36 months
In-field toxicity, defined as bleeding or perforation of the tracheobronchial or gastrointestinal structures within the radiation field
时间窗: Up to 36 months
Clinical response
时间窗: Up to 36 months
Correlation of levels of angiopoietin-2 and vascular endothelial growth factor receptor-2 with clinical response
时间窗: Up to 36 months
次要结局
未报告次要终点