Lung Cancer Clinical Trial
Radiation Therapy, Chemotherapy, and Bevacizumab in Treating Patients With Recurrent, Unresectable or Stage III or Stage IV Non-Small Cell Lung Cancer
Summary
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.
Full Description
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.
Eligibility Criteria
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
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There are 5 Locations for this study
Birmingham Alabama, 35294, United States
Chicago Illinois, 60611, United States
Evanston Illinois, 60201, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75390, United States
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