Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368992
Status:
COMPLETED
Last Update Posted:
2015-09-14
First Post:
2006-08-24
Brief Title:
S0536 Cetuximab Paclitaxel Carboplatin and Bevacizumab in Treating Patients With Advanced Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Combination Carboplatin Paclitaxel Cetuximab and Bevacizumab NSC-704865 Followed By Cetuximab and Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2013-02
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:
Monoclonal antibodies such as cetuximab and bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Bevacizumab may stop the growth of tumor cells by blocking blood flow to the tumor Drugs used in chemotherapy such as paclitaxel and carboplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving cetuximab together with paclitaxel carboplatin and bevacizumab may kill more tumor cells This phase II trial is studying how well giving cetuximab together with paclitaxel carboplatin and bevacizumab works in treating patients with advanced non-small cell lung cancer
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the frequency and severity of hemorrhage toxicities in patients with advanced non-small cell lung cancer treated with the combination of carboplatin paclitaxel cetuximab and bevacizumab followed by therapy with cetuximab and bevacizumab
SECONDARY OBJECTIVES
I To evaluate progression-free and overall survival response rate confirmed plus unconfirmed complete plus partial and frequency and severity of non-hemorrhage toxicities in this group of patients treated with this regimen
II To perform molecular correlative studies on patient tissue to investigate in an exploratory manner potential predictors of efficacy
OUTLINE This is a multicenter study
INDUCTION THERAPY Patients receive cetuximab IV over 1-2 hours on days 1 8 and 15 and paclitaxel IV over 3 hours carboplatin IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
MAINTENANCE THERAPY Patients receive cetuximab IV over 1 hour on days 1 8 and 15 and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months for up to 3 years
I To evaluate the frequency and severity of hemorrhage toxicities in patients with advanced non-small cell lung cancer treated with the combination of carboplatin paclitaxel cetuximab and bevacizumab followed by therapy with cetuximab and bevacizumab
SECONDARY OBJECTIVES
I To evaluate progression-free and overall survival response rate confirmed plus unconfirmed complete plus partial and frequency and severity of non-hemorrhage toxicities in this group of patients treated with this regimen
II To perform molecular correlative studies on patient tissue to investigate in an exploratory manner potential predictors of efficacy
OUTLINE This is a multicenter study
INDUCTION THERAPY Patients receive cetuximab IV over 1-2 hours on days 1 8 and 15 and paclitaxel IV over 3 hours carboplatin IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
MAINTENANCE THERAPY Patients receive cetuximab IV over 1 hour on days 1 8 and 15 and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months for up to 3 years
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 | None | httpsreporternihgovquickSearchU10CA032102 |
| S0536 | None | None | None |