A Phase II Trial Using Amifostine as a Chemo/Radio Protective Agent in the Treatment of Limited Stage Small-Cell Lung Cancer
OBJECTIVES: I. Evaluate the reduction in toxicities by combining amifostine with cisplatin,
etoposide, and radiotherapy in patients with limited stage small cell lung cancer. II.
Evaluate the response rate to this combination by these patients. III. Evaluate the overall
survival of patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive cisplatin IV on day 1 and etoposide
IV daily on days 1-3. This course is repeated every 3 weeks for a total for 4 courses.
Patients also receive concurrent radiotherapy 5 days per week for 5.5 weeks starting with
the first course of chemotherapy. Patients receive amifostine IV over 15 minutes 15-30
minutes prior to each dose of chemotherapy on days 1-3. Patients are followed at 6 and 12
weeks, then every 3 months for 9 months, every 6 months for 1 year, and then until death.
PROJECTED ACCRUAL: There will be 20 patients accrued into this study.
Primary Purpose: Supportive Care
Dean L. McCarley, MD
Veterans Affairs Medical Center - Gainesville
United States: Federal Government
|University of Florida - Gainesville||Gainesville, Florida 32610-0277|