Pilot Study of a Combination of Standard Etoposide/Cisplatin and Metronomic Cyclophosphamide in Patients With Newly Diagnosed Extensive Stage Small Cell Lung Cancer
- Determine the safety of cisplatin, etoposide, and cyclophosphamide in patients with
extensive stage small cell lung cancer.
- Determine the effect of this regimen on circulating endothelial cells in the peripheral
blood of these patients.
- Determine progression-free survival, tumor response rate, and overall survival in
patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive cisplatin IV over 30 minutes-2 hours on day 1,
etoposide IV over 1-2 hours on days 1-3 OR etoposide IV on day 1 and orally twice daily
on days 2-3, and oral cyclophosphamide twice daily on days 8-19. Treatment repeats
every 21 days for 4 courses in the absence of disease progression or unacceptable
- Maintenance therapy: Patients receive oral cyclophosphamide twice daily in the absence
of disease progression.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
From time of registration to 30 days post treatment of last cycle.
Ronald S. Go, MD
Gundersen Lutheran Center for Cancer and Blood
United States: Federal Government
|Gundersen Lutheran Center for Cancer and Blood||La Crosse, Wisconsin 54601|