A Phase II Evaluation of Ethyol as an Esophageal Mucosal Protectant in the Treatment of Limited Disease Small Cell Lung Cancer With Chemotherapy and Twice-Daily Radiation
OBJECTIVES: I. Determine the incidence and duration of moderate and severe acute esophagitis
in patients with limited stage small cell lung cancer treated with amifostine
chemoprotection plus chemotherapy and radiotherapy. II. Determine the tumor response to this
regimen in these patients.
OUTLINE: Course 1: Patients receive amifostine IV over 5 minutes daily, followed by
radiotherapy twice daily Monday through Friday for 3 weeks. Patients receive cisplatin IV
over 30-60 minutes on day 1, and etoposide IV over 1 hour on days 1, 2, and 3. Courses 2-4:
Patients receive amifostine over 15 minutes on day 1, followed by cisplatin IV over 30-60
minutes and etoposide IV over 1 hour every 3 weeks. Patients are followed at 1 month, then
every 3 months until death.
PROJECTED ACCRUAL: Approximately 33 patients will be accrued for this study within 1-2
Primary Purpose: Treatment
William H. Read, M.D.
Washington University School of Medicine
United States: Institutional Review Board
|Lineberger Comprehensive Cancer Center, UNC||Chapel Hill, North Carolina 27599-7295|
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|
|Washington University Barnard Cancer Center||Saint Louis, Missouri 63110|
|Rocky Mountain Cancer Center||Denver, Colorado 80218|