Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034541
Status:
COMPLETED
Last Update Posted:
2010-04-09
First Post:
2002-04-30
Brief Title:
Study of Cetuximab in Combination With Carboplatin-Paclitaxel in Non-Small Cell Lung Cancer
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
Phase IbIIa Study of an Anti-Epidermal Growth Factor Receptor EGFr Antibody Cetuximab in Combination With Carboplatin-Paclitaxel in Patients With Chemotherapy-Naive Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2010-04
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:
The study will enroll approximately 33 EGFr positive chemotherapy-naive stage IV non-small cell lung cancer patients Patients will receive cetuximab in combination with carboplatin and paclitaxel for two cycles or until disease progression or until the patient exhibits intolerable toxicities Patients will be evaluated for efficacy and safety throughout the duration of the study
Detailed Description:
The study will enroll approximately 33 chemotherapy-naive stage IV non-small cell lung cancer patients Patients will receive 3-week cycles of therapy with the exception of the initial cycle where the patients will receive 4 cycles of therapy Patients will be enrolled after EGFr expression is confirmed and the study inclusion and exclusion criteria are met An initial dose of cetuximab will be administered prior to the initiation of chemotherapy Thereafter cetuximab will be infused weekly On the first day of each cycle a paclitaxel infusion will be administered post completion of the cetuximab infusion immediately followed by a carboplatin infusion Patients will receive cetuximab in combination with carboplatin and paclitaxel for two cycles or until disease progression or until the patient exhibits intolerable toxicities Patients will be evaluated for a tumor response at the end of every two cycles of therapy and evaluated for safety throughout the 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