Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00029003
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
2002-01-04
Brief Title:
Gefitinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
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 2152003
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 2152003
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:
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 |
|---|---|---|---|
| CDR0000069157 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA032102 |
| S0126 | None | None | None |
| U10CA032102 | NIH | None | None |