Radiation Therapy, Chemotherapy, and Bevacizumab in Treating Patients With Recurrent, Unresectable or Stage III or Stage IV 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.
|Lung Cancer||Biological: bevacizumab Drug: carboplatin Drug: chemoprotection Drug: paclitaxel Radiation: radiation therapy||Phase 2|
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|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|
- Reduction in toxicity measured by pulmonary hemorrhage rate
- Overall survival by Kaplan-Meier
- Response rate
|Study Start Date:||May 2006|
|Study Completion Date:||November 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00334763
|United States, Alabama|
|Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|Evanston Northwestern Healthcare - Evanston Hospital|
|Evanston, Illinois, United States, 60201-1781|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|United States, Texas|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Jyoti D. Patel||Robert H. Lurie Cancer Center|