Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085501
Status:
COMPLETED
Last Update Posted:
2012-11-01
First Post:
2004-06-10
Brief Title:
S0342 Paclitaxel Carboplatin and Cetuximab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase II Selection Design Trial Of Concurrent Chemotherapy Cetuximab Vs Chemotherapy Followed By Cetuximab In Advanced Non-Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2012-10
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 paclitaxel and carboplatin work in different ways to stop tumor cells from dividing so they stop growing or die Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Combining more than one chemotherapy drug with a monoclonal antibody may kill more tumor cells It is not yet known whether cetuximab is more effective when given at the same time as chemotherapy or following chemotherapy
PURPOSE This randomized phase II trial is studying how well giving cetuximab at the same time as combination chemotherapy works compared to giving cetuximab after combination chemotherapy in treating patients with stage IIIB or stage IV non-small cell lung cancer
PURPOSE This randomized phase II trial is studying how well giving cetuximab at the same time as combination chemotherapy works compared to giving cetuximab after combination chemotherapy in treating patients with stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Compare overall survival of patients with selected stage IIIB or stage IV non-small cell lung cancer treated with concurrent vs sequential paclitaxel carboplatin and cetuximab
Secondary
Compare response rates confirmed and unconfirmed complete and partial in patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Correlate epidermal growth factor receptor polymorphisms and downstream biomarkers with response to cetuximab in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I concurrent cetuximab Patients receive cetuximab IV over 1 hour over 2 hours on day 1 of course 1 only on days 1 8 and 15 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 8 Treatment repeats every 21 days for a total of 4 courses 12 weeks in the absence of disease progression or unacceptable toxicity Beginning on week 13 patients receive single-agent cetuximab IV over 1 hour once weekly in the absence of disease progression or unacceptable toxicity
Arm II sequential cetuximab Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for a total of 4 courses 12 weeks in the absence of disease progression or unacceptable toxicity Beginning on week 13 patients receive single-agent cetuximab IV over 1 hour over 2 hours on week 13 only once weekly in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 180 patients 90 per treatment arm will be accrued for this study within 9 months
Primary
Compare overall survival of patients with selected stage IIIB or stage IV non-small cell lung cancer treated with concurrent vs sequential paclitaxel carboplatin and cetuximab
Secondary
Compare response rates confirmed and unconfirmed complete and partial in patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Correlate epidermal growth factor receptor polymorphisms and downstream biomarkers with response to cetuximab in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I concurrent cetuximab Patients receive cetuximab IV over 1 hour over 2 hours on day 1 of course 1 only on days 1 8 and 15 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 8 Treatment repeats every 21 days for a total of 4 courses 12 weeks in the absence of disease progression or unacceptable toxicity Beginning on week 13 patients receive single-agent cetuximab IV over 1 hour once weekly in the absence of disease progression or unacceptable toxicity
Arm II sequential cetuximab Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for a total of 4 courses 12 weeks in the absence of disease progression or unacceptable toxicity Beginning on week 13 patients receive single-agent cetuximab IV over 1 hour over 2 hours on week 13 only once weekly in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 180 patients 90 per treatment arm will be accrued for this study within 9 months
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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0342 | OTHER | None | None |