Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425646
Status:
COMPLETED
Last Update Posted:
2013-05-06
First Post:
2007-01-19
Brief Title:
Imatinib Mesylate and Bevacizumab After First-Line Chemotherapy and Bevacizumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
A Phase II Study Evaluating a Maintenance Strategy of Gleevce Imatinib Mesylate and Bevacizumab in Patients With Advanced Non-squamous Non-small Cell Lung Cancer Following Completion of First-line Chemotherapy With Bevacizumab
Status:
COMPLETED
Status Verified Date:
2013-05
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 Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth 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 Imatinib mesylate and bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor Giving imatinib mesylate together with bevacizumab as maintenance therapy may stop non-small cell lung cancer from growing or coming back
PURPOSE This phase II trial is studying how well giving imatinib mesylate together with bevacizumab after first-line chemotherapy and bevacizumab works in treating patients with stage IIIB or stage IV non-small cell lung cancer
PURPOSE This phase II trial is studying how well giving imatinib mesylate together with bevacizumab after first-line chemotherapy and bevacizumab works in treating patients with stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the clinical efficacy of maintenance therapy comprising imatinib mesylate and bevacizumab after completion of first-line platinum-based chemotherapy and bevacizumab in terms of progression-free survival in patients with stage IIIB or IV non-small cell lung cancer
Secondary
Assess the safety profile of this regimen in these patients
OUTLINE This is an open-label multicenter study
Patients receive oral imatinib mesylate twice daily on days 1-21 and bevacizumab IV over 30 minutes on day 1 Treatment repeats every 21 days for 1 year in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Primary
Determine the clinical efficacy of maintenance therapy comprising imatinib mesylate and bevacizumab after completion of first-line platinum-based chemotherapy and bevacizumab in terms of progression-free survival in patients with stage IIIB or IV non-small cell lung cancer
Secondary
Assess the safety profile of this regimen in these patients
OUTLINE This is an open-label multicenter study
Patients receive oral imatinib mesylate twice daily on days 1-21 and bevacizumab IV over 30 minutes on day 1 Treatment repeats every 21 days for 1 year in the absence of disease progression or unacceptable toxicity
After completion of study treatment 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 |
|---|---|---|---|
| CDR0000526130 | REGISTRY | PDQ | None |
| UWCC-6351 | None | None | None |
| UWCC-06-3622-HB | None | None | None |
| NOVARTIS-UWCC-6351 | None | None | None |