Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369551
Status:
TERMINATED
Last Update Posted:
2014-03-06
First Post:
2006-08-24
Brief Title:
Bevacizumab Paclitaxel Carboplatin and Radiation Therapy to the Chest in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Safety and Feasibility Study of Bevacizumab With Paclitaxel Carboplatin and Chest Radiotherapy in Patients With Locally Advanced Non-Small Lung Cancer
Status:
TERMINATED
Status Verified Date:
2013-01
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 phase I trial studies how well giving bevacizumab together with paclitaxel carboplatin and radiation therapy to the chest works in treating patients with locally advanced non-small cell lung cancer Monoclonal antibodies such as 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 Bevacizumab may also 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 Radiation therapy uses high-energy x-rays to kill tumor cells Giving bevacizumab together with paclitaxel carboplatin and radiation therapy may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Assess the feasibility of administering bevacizumab paclitaxel carboplatin and chest radiotherapy in patients with locally advanced non-small cell lung cancer
II Characterize the toxicity of this treatment regimen III Assess the clinical response to this treatment regimen IV Correlate circulating levels of angiopoietin-2 and vascular endothelial growth factor receptor-2 with clinical response to this treatment regimen
OUTLINE This is an open-label multicenter studyInduction therapy
Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30-60 minutes on days 1 8 15 22 29 36 and 43 and bevacizumab IV over 30-90 minutes on days 1 15 29 and 43 Patients also undergo chest radiotherapy 5 days a week for 7 weeks beginning on day 1
Consolidation therapy Beginning 4-5 weeks after completion chemoradiotherapy patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 1 hour followed by bevacizumab IV over 30 minutes Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity
After study completion patients are followed periodically for 36 months
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
I Assess the feasibility of administering bevacizumab paclitaxel carboplatin and chest radiotherapy in patients with locally advanced non-small cell lung cancer
II Characterize the toxicity of this treatment regimen III Assess the clinical response to this treatment regimen IV Correlate circulating levels of angiopoietin-2 and vascular endothelial growth factor receptor-2 with clinical response to this treatment regimen
OUTLINE This is an open-label multicenter studyInduction therapy
Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30-60 minutes on days 1 8 15 22 29 36 and 43 and bevacizumab IV over 30-90 minutes on days 1 15 29 and 43 Patients also undergo chest radiotherapy 5 days a week for 7 weeks beginning on day 1
Consolidation therapy Beginning 4-5 weeks after completion chemoradiotherapy patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 1 hour followed by bevacizumab IV over 30 minutes Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity
After study completion patients are followed periodically for 36 months
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
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 |
|---|---|---|---|
| N01CM62201 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62201 |
| NCI-2012-02718 | REGISTRY | None | None |
| UCCRC-14576A | None | None | None |
| CDR0000491998 | None | None | None |
| NCI-7213 | None | None | None |
| 14576A | OTHER | None | None |
| 7213 | OTHER | None | None |
| P30CA014599 | NIH | None | None |