Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00309998
Status:
COMPLETED
Last Update Posted:
2014-09-17
First Post:
2006-03-29
Brief Title:
Vinorelbine and Bevacizumab in Treating Older Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Vinorelbine Plus Bevacizumab as First Line Therapy in Patients 70 Years of Age With Stage IIIBIV Non-Squamous Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as vinorelbine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing 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 Giving vinorelbine together with bevacizumab may kill more tumor cells
PURPOSE This phase II trial is studying how well giving vinorelbine together with bevacizumab works in treating older patients with stage III or stage IV non-small cell lung cancer
PURPOSE This phase II trial is studying how well giving vinorelbine together with bevacizumab works in treating older patients with stage III or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Estimate the median time to disease progression in older patients with non-squamous stage IIIB or stage IV non-small cell lung cancer NSCLC treated with vinorelbine ditartate and bevacizumab
Secondary
Estimate the response rate in patients treated with this regimen
Estimate the median survival in patients treated with this regimen
Evaluate the safety of the combination of vinorelbine ditartate and bevacizumab in older patients
OUTLINE This is an open-label study
Patients receive vinorelbine ditartate IV over 6 to 10 minutes on days 1 and 8 and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression
After completion of study therapy patients are followed periodically
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Primary
Estimate the median time to disease progression in older patients with non-squamous stage IIIB or stage IV non-small cell lung cancer NSCLC treated with vinorelbine ditartate and bevacizumab
Secondary
Estimate the response rate in patients treated with this regimen
Estimate the median survival in patients treated with this regimen
Evaluate the safety of the combination of vinorelbine ditartate and bevacizumab in older patients
OUTLINE This is an open-label study
Patients receive vinorelbine ditartate IV over 6 to 10 minutes on days 1 and 8 and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression
After completion of study therapy patients are followed periodically
PROJECTED ACCRUAL A total of 50 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 |
|---|---|---|---|
| GENENTECH-AVF3328S | None | None | None |
| URCC-U1505 | None | None | None |