Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00234052
Status:
COMPLETED
Last Update Posted:
2019-06-04
First Post:
2005-10-05
Brief Title:
Carboplatin Pemetrexed Disodium and Bevacizumab in Treating Patients With Stage IIIB Stage IV or Recurrent Non-Small Cell Lung Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Phase II Trial of Carboplatin and Pemetrexed Plus Bevacizumab in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2019-01
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:
RATIONALE Drugs used in chemotherapy such as carboplatin and pemetrexed disodium work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Pemetrexed disodium may also 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 Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor Giving carboplatin and pemetrexed disodium together with bevacizumab may kill more tumor cells
PURPOSE This phase II trial is studying how well giving carboplatin and pemetrexed disodium together with bevacizumab works in treating patients with stage IIIB stage IV or recurrent non-small cell lung cancer
PURPOSE This phase II trial is studying how well giving carboplatin and pemetrexed disodium together with bevacizumab works in treating patients with stage IIIB stage IV or recurrent non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the median time to disease progression in patients with stage IIIB or IV or recurrent non-squamous cell non-small cell lung cancer treated with carboplatin pemetrexed disodium and bevacizumab
Secondary
Determine the response rate and duration of response in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine the overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive pemetrexed disodium IV over 10 minutes carboplatin IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity After completion of 6 courses patients with complete response partial response or stable disease continue to receive pemetrexed disodium and bevacizumab in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Primary
Determine the median time to disease progression in patients with stage IIIB or IV or recurrent non-squamous cell non-small cell lung cancer treated with carboplatin pemetrexed disodium and bevacizumab
Secondary
Determine the response rate and duration of response in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine the overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive pemetrexed disodium IV over 10 minutes carboplatin IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity After completion of 6 courses patients with complete response partial response or stable disease continue to receive pemetrexed disodium and bevacizumab in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 3 years
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 |
|---|---|---|---|
| NU-04L2 | None | None | None |
| STU00007415 | OTHER | Northwestern University IRB | None |