Lung Cancer Clinical Trial
Official title:
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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