Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283244
Status:
COMPLETED
Last Update Posted:
2017-04-24
First Post:
2006-01-24
Brief Title:
Ph II Gemcitabine Erlotinib and Gemcitabine With ErlotinibElderly Patients W IIIBIV NSCLC
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
Randomized Phase II Study of First-Line Treatment With Gemcitabine vs Erlotinib vs Gemcitabine and Erlotinib in Elderly Patients With Stage IIIBIV Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2017-03
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:
RATIONALE Drugs used in chemotherapy such as gemcitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth It is not yet known whether gemcitabine and erlotinib are more effective when given alone or together in treating non-small cell lung cancer
PURPOSE This randomized phase II trial is studying gemcitabine and erlotinib to compare how well they work when given alone or together as first-line therapy in treating older patients with stage IIIB or stage IV non-small cell lung cancer
PURPOSE This randomized phase II trial is studying gemcitabine and erlotinib to compare how well they work when given alone or together as first-line therapy in treating older patients with stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Compare the progression-free survival rate of older patients with stage IIIB or IV non-small cell lung cancer treated with gemcitabine hydrochloride vs erlotinib hydrochloride vs gemcitabine hydrochloride and erlotinib hydrochloride as first-line therapy
Secondary
Determine the response rate in patients receiving these regimens
Determine the overall survival rate in patients receiving these regimens
Determine the toxicity profile of these regimens in these patients
Determine the quality of life of patients receiving these regimens
OUTLINE This is a randomized open-label controlled parallel group multicenter study Patients are stratified by gender smoking status never or light vs current or former and ECOG performance status 0-1 vs 2 Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive gemcitabine hydrochloride IV on days 1 and 8 Patients with progressive disease may cross over to arm II
Arm II Patients receive oral erlotinib hydrochloride daily on days 1-21
Arm III Patients receive gemcitabine hydrochloride as in arm I and erlotinib hydrochloride as in arm II
In all arms treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed every 2 months for 3 years
Primary
Compare the progression-free survival rate of older patients with stage IIIB or IV non-small cell lung cancer treated with gemcitabine hydrochloride vs erlotinib hydrochloride vs gemcitabine hydrochloride and erlotinib hydrochloride as first-line therapy
Secondary
Determine the response rate in patients receiving these regimens
Determine the overall survival rate in patients receiving these regimens
Determine the toxicity profile of these regimens in these patients
Determine the quality of life of patients receiving these regimens
OUTLINE This is a randomized open-label controlled parallel group multicenter study Patients are stratified by gender smoking status never or light vs current or former and ECOG performance status 0-1 vs 2 Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive gemcitabine hydrochloride IV on days 1 and 8 Patients with progressive disease may cross over to arm II
Arm II Patients receive oral erlotinib hydrochloride daily on days 1-21
Arm III Patients receive gemcitabine hydrochloride as in arm I and erlotinib hydrochloride as in arm II
In all arms treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed every 2 months for 3 years
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 |
|---|---|---|---|
| UNC-LCCC-0512 | OTHER | UNC IRB 05-2256 | httpsreporternihgovquickSearchP30CA016086 |
| P30CA016086 | NIH | None | None |