Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081302
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
2004-04-07
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:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase II Study Of Cetuximab C225 In Combination With Chemoradiation In Patients With Stage IIIAB 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:
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 |
|---|---|---|---|
| CDR0000352163 | None | None | None |