Lung Cancer Clinical Trial
Official title:
A Randomized, Double Blind, Phase III Comparative Trial of 2 Doses of ZD1839 (IRESSA) in Combination With Gemcitabine and Cisplatin Versus Placebo in Combination With Gemcitabine and Cisplatin in Chemotherapy Naive Patients With Advanced (Stage III or IV) Non-Small Cell Lung Cancer
RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep
growing. ZD 1839 may interfere with the growth factor and stop the tumor from growing. Drugs
used in chemotherapy use different ways to stop tumor cells from dividing so they stop
growing or die. It is not yet known whether chemotherapy is more effective with or without
ZD 1839 for non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy
with or without ZD 1839 in treating patients who have stage IIIB or stage IV non-small cell
lung cancer.
OBJECTIVES: I. Compare the 1 year survival rate, time to worsening of disease related
symptoms, and progression free survival in chemotherapy naive patients with stage IIIB or IV
non-small cell lung cancer treated with one of two doses of ZD 1839 or placebo combined with
gemcitabine and cisplatin.
OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients
are randomized to one of three treatment arms. Patients receive gemcitabine and cisplatin
combined with lower dose oral ZD 1839 (arm I), higher dose oral ZD 1839 (arm II), or placebo
(arm III).
PROJECTED ACCRUAL: A total of 1,029 patients (343 per arm) will be accrued for this study.
;
Primary Purpose: Treatment
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