Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00492206
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2007-06-26
Brief Title:
Study of Cetuximab With Radiation Followed by Consolidation Chemotherapy for NSCLC
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Phase II Study of Cetuximab in Combination With External Beam Radiation Followed By Consolidation Chemotherapy for Patients With Locally Advanced Non-Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2016-12
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:
This is an open label phase II study in which cetuximab with concurrent thoracic radiotherapy followed by consolidation chemotherapy with paclitaxelcarboplatincetuximab will be administered to subjects with locally advanced NSCLC
Detailed Description:
This is a Phase II study to determine the overall survival for patients with locally advanced NSCLC treated with cetuximab with concurrent thoracic radiotherapy followed by consolidation chemotherapy with paclitaxelcarboplatincetuximab This is a multicenter study including 36 subjects who will be males and females both greater than 18 years of age All subjects will initially receive radiation and cetuximab Radiation will be given once a day Monday-Friday for approximately 6-8 weeks During the course of radiation cetuximab will be given intravenously once a week Approximately 4-6 weeks after the last radiation dose the subjects will be treated with chemotherapy paclitaxelcarboplatin Chemotherapy will be given intravenously once every 3 weeks for 3 cycles 1 cycle3 weeks Cetuximab intravenous administration will be continued throughout the entire study once a week through week 26 including during chemotherapy
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 |
|---|---|---|---|
| NCT00492206 | REGISTRY | ClinicalTrialsgov | None |