ZD 1839 Plus Combination Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00006048|
Recruitment Status : Unknown
Verified July 2001 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : April 26, 2004
Last Update Posted : December 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: cisplatin Drug: gefitinib Drug: gemcitabine hydrochloride||Phase 3|
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.
|Study Type :||Interventional (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|
|Study Start Date :||May 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006048
|United States, Delaware|
|AstraZeneca Pharmaceuticals LP|
|Wilmington, Delaware, United States, 19850-5437|
|Study Chair:||Ron Staugarrd||AstraZeneca|