Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT00081302
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
2004-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cetuximab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Unresectable Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Study Overview
Official Title:
A Phase II Study Of Cetuximab (C225) In Combination With Chemoradiation In Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)
Status:
COMPLETED
Status Verified Date:
2015-11
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: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving cetuximab together with combination chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with paclitaxel, carboplatin, and radiation therapy works in treating patients with unresectable stage IIIA or stage IIIB non-small cell lung cancer.
PURPOSE: This phase II trial is studying how well giving cetuximab together with paclitaxel, carboplatin, and radiation therapy works in treating patients with unresectable stage IIIA or stage IIIB non-small cell lung cancer.
Detailed Description:
OBJECTIVES:
Primary
* Determine the feasibility of cetuximab when administered concurrently with paclitaxel, carboplatin, and radiotherapy, in terms of safety and compliance, in patients with unresectable stage IIIA or IIIB non-small cell lung cancer.
Secondary
* Determine the response rate (complete and partial) in patients treated with this regimen.
* Determine the overall survival (1- and 2-year survival rate and median survival) of patients treated with this regimen.
* Determine the time to disease progression (at 1 and 2 years) in patients treated with this regimen.
* Correlate epidermal growth factor receptor expression with the toxicity of this regimen and response, overall survival, and progression in these patients.
OUTLINE: This is a multicenter study.
* Cetuximab loading dose (week 1): Patients receive a loading dose of cetuximab IV over 2 hours on day 1.
* Concurrent cetuximab and chemoradiotherapy (weeks 2-8): Patients receive cetuximab IV over 1 hour, paclitaxel IV over 1 hour, and carboplatin IV over 30 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients undergo radiotherapy once daily on days 8-12, 15-19, 22-26, 29-33, 36-40, 43-47, and 50-53.
* Consolidation therapy (weeks 9-17): Patients receive cetuximab IV over 1 hour on days 57, 64, 71, 78, 85, 92, 99, 106, and 113. Patients also receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on days 78 and 99.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed at 30 days, every 3 months for 2 years, every 4 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 1 year.
Primary
* Determine the feasibility of cetuximab when administered concurrently with paclitaxel, carboplatin, and radiotherapy, in terms of safety and compliance, in patients with unresectable stage IIIA or IIIB non-small cell lung cancer.
Secondary
* Determine the response rate (complete and partial) in patients treated with this regimen.
* Determine the overall survival (1- and 2-year survival rate and median survival) of patients treated with this regimen.
* Determine the time to disease progression (at 1 and 2 years) in patients treated with this regimen.
* Correlate epidermal growth factor receptor expression with the toxicity of this regimen and response, overall survival, and progression in these patients.
OUTLINE: This is a multicenter study.
* Cetuximab loading dose (week 1): Patients receive a loading dose of cetuximab IV over 2 hours on day 1.
* Concurrent cetuximab and chemoradiotherapy (weeks 2-8): Patients receive cetuximab IV over 1 hour, paclitaxel IV over 1 hour, and carboplatin IV over 30 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients undergo radiotherapy once daily on days 8-12, 15-19, 22-26, 29-33, 36-40, 43-47, and 50-53.
* Consolidation therapy (weeks 9-17): Patients receive cetuximab IV over 1 hour on days 57, 64, 71, 78, 85, 92, 99, 106, and 113. Patients also receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on days 78 and 99.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed at 30 days, every 3 months for 2 years, every 4 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 1 year.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CDR0000352163 | None | None | View |