Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006049
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
2000-07-05
Brief Title:
ZD 1839 Plus Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer
Sponsor:
AstraZeneca
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2001-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Some tumors need growth factors produced by the bodys 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
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
Detailed Description:
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 1029 patients will be accrued for this study
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 1029 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC-00100 | None | None | None |
| ZENECA-1839IL0017 | None | None | None |