Phase II Trial of Bevacizumab in Combination With Cisplatin/Etoposide and Twice Daily Radiation for Patients With Limited-Stage Small Cell Lung Cancer
- Determine the 1-year progression-free survival of patients with limited-stage small
cell lung cancer treated with bevacizumab, cisplatin, etoposide, and radiotherapy.
- Determine the toxicity of this regimen in these patients.
- Determine the response rate in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive cisplatin IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on
day 1 and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for 4
courses in the absence of disease progression or unacceptable toxicity. During course 1,
patients also undergo thoracic radiotherapy twice daily on days 1-5, 8-12, and 15-19.
Patients achieving a complete or partial response or stable disease after the first 4
courses of chemotherapy continue to receive bevacizumab IV over 30-90 minutes on day 1.
Treatment with bevacizumab repeats every 21 days for up to 1 year in the absence of disease
progression or unacceptable toxicity.
Within 4-6 weeks after blood counts recover from the first 4 courses of chemotherapy,
patients achieving a complete or partial response also undergo prophylactic cranial
irradiation (PCI) in 10 fractions over 3 weeks.*
NOTE: *Bevacizumab should not be given for 3 weeks prior to or during PCI, but resumed 1
week after completion of PCI.
After completion of study treatment, patients are followed periodically for 10 years.
PROJECTED ACCRUAL: A total of 79 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Progression-free survival at 1 year
Afshin Dowlati, MD
Case Comprehensive Cancer Center
United States: Food and Drug Administration