Radiation Therapy, Chemotherapy, and Bevacizumab in Treating Patients With Recurrent, Unresectable or Stage III or Stage IV Non-Small Cell Lung Cancer
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
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.
研究概览
详细说明
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.
OUTLINE: Patients undergo radiotherapy to the primary tumor, clinically involved lymph nodes, and any other disease-causing symptoms or bronchial compression once daily, 5 days a week, for 2 weeks in weeks 1 and 2. Beginning in week 4, patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment with paclitaxel, carboplatin, and bevacizumab repeats every 3 weeks for 4 courses in the absence of unacceptable toxicity. Patients achieving complete response, partial response, or stable disease after 4 courses receive bevacizumab alone as above in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Alabama
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Birmingham、Alabama、美国、35294
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
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Illinois
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Chicago、Illinois、美国、60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Evanston、Illinois、美国、60201-1781
- Evanston Northwestern Healthcare - Evanston Hospital
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Tennessee
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Nashville、Tennessee、美国、37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
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Dallas、Texas、美国、75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
- More than 4 weeks since prior and no concurrent participation in another experimental drug study
No concurrent therapeutic anticoagulation
- Concurrent prophylactic anticoagulation of venous access device allowed
- No concurrent chronic treatment with aspirin (> 325 mg/day) or nonsteroidal anti-inflammatory drugs known to inhibit platelet function
- No concurrent dipyridamole, ticlopidine, clopidogrel, or cilostazol
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
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Reduction in toxicity measured by pulmonary hemorrhage rate
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次要结果测量
结果测量 |
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毒性
|
反应速度
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Overall survival by Kaplan-Meier
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合作者和调查者
调查人员
- 首席研究员:Jyoti D. Patel、Robert H. Lurie Cancer Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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