Lung Cancer Clinical Trial
Official title:
A Phase II Trial Using Amifostine as a Chemo/Radio Protective Agent in the Treatment of Limited Stage Small-Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Drugs such as amifostine may protect normal cells from the side
effects of chemotherapy and radiation therapy.
PURPOSE: Phase II trial to study the effectiveness of amifostine to prevent side effects in
patients who are receiving chemotherapy and radiation therapy for 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
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