ZD 1839 Plus Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00006049|
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 combination 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 III or stage IV non-small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: carboplatin Drug: gefitinib Drug: paclitaxel||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 paclitaxel and carboplatin. II. Compare the quality of life of patients treated with these three regimens.
OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are randomized to one of three treatment arms. All patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 15-30 minutes on day 1. Patients receive lower dose oral ZD 1839 (arm I), higher dose oral ZD 1839 (arm II), or placebo (arm III) twice on day 1, and then once daily thereafter. Chemotherapy repeats every 3 weeks for a maximum of 6 courses. ZD 1839 or placebo continues daily in the absence of disease progression or unacceptable toxicity. Quality of life is assessed prior to study, then every 3 weeks until completion of chemotherapy, then every 4 weeks until completion of oral ZD 1839 or placebo, and then every 8 weeks thereafter. Patients are followed every 8 weeks.
PROJECTED ACCRUAL: A total of 1,029 patients 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 Paclitaxel and Carboplatin Versus Placebo in Combination With Paclitaxel and Carboplatin in Chemotherapy-Naive Patients With Advanced (Stage III or IV) Non-Small Cell Lung Cancer|
|Study Start Date :||May 2000|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006049
|United States, Delaware|
|AstraZeneca Pharmaceuticals LP|
|Wilmington, Delaware, United States, 19850-5437|
|Study Chair:||Ron Staugarrd||AstraZeneca|