Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-25 @ 5:05 PM
Study NCT ID:
NCT00029003
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
2002-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gefitinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Phase II Trial of Chronic Oral ZD1839 (Iressa®) (NSC-715055) in Both Previously-Untreated and Previously-Treated Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
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:
Phase II trial to study the effectiveness of gefitinib in treating patients who have stage IIIB or stage IV non-small cell lung cancer. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of non-small cell lung cancer
Detailed Description:
PRIMARY OBJECTIVES:
I. To assess the one-years survival rate in both previously-untreated and previously-treated patients with advanced bronchioalveolar carcinoma receiving chronic oral ZD1839.
II. To assess the progression-free survival and overall survival in these groups of patients.
III. To evaluate the frequency and severity of toxicities associated with this treatment regimen.
IV. To evaluate the response rate using both the standard RECIST criteria and by computer-assisted image analysis in patients with measurable disease.
V. To measure EGFR and EGFR variant III overexpression in tumor tissue samples and explore their relationship with aforementioned clinical outcomes.
VI. To measure EGFR expression and activation status in slides of buccal brushings submitted on S9925 before and after initiation of treatment with ZD1839 and explore their association with response and survival.
OUTLINE: This is a multicenter study. Patients are stratified according to prior systemic treatment for bronchioalveolar carcinoma (yes vs no). (The previously untreated stratum closed to accrual as of 2/15/2003.)
Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 2 years and then annually thereafter.
I. To assess the one-years survival rate in both previously-untreated and previously-treated patients with advanced bronchioalveolar carcinoma receiving chronic oral ZD1839.
II. To assess the progression-free survival and overall survival in these groups of patients.
III. To evaluate the frequency and severity of toxicities associated with this treatment regimen.
IV. To evaluate the response rate using both the standard RECIST criteria and by computer-assisted image analysis in patients with measurable disease.
V. To measure EGFR and EGFR variant III overexpression in tumor tissue samples and explore their relationship with aforementioned clinical outcomes.
VI. To measure EGFR expression and activation status in slides of buccal brushings submitted on S9925 before and after initiation of treatment with ZD1839 and explore their association with response and survival.
OUTLINE: This is a multicenter study. Patients are stratified according to prior systemic treatment for bronchioalveolar carcinoma (yes vs no). (The previously untreated stratum closed to accrual as of 2/15/2003.)
Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 2 years and then annually thereafter.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| S0126 | None | None | View | |
| U10CA032102 | NIH | None | https://reporter.nih.gov/quic… | View |
| CDR0000069157 | REGISTRY | PDQ (Physician Data Query) | View |