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
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Reduction in toxicity measured by pulmonary hemorrhage rate
Yes
Jyoti D. Patel
Principal Investigator
Robert H. Lurie Cancer Center
United States: Food and Drug Administration
NU 05L1
NCT00334763
May 2006
November 2007
Name | Location |
---|---|
Evanston Northwestern Healthcare - Evanston Hospital | Evanston, Illinois 60201-1781 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | Birmingham, Alabama 35294 |