Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025389
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2001-10-11
Brief Title:
Bevacizumab Paclitaxel and Carboplatin Before Surgery in Treating Patients With Stage IB Stage II or Stage IIIA Non-Small Cell Lung Cancer
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Phase 2 Study Of Neoadjuvant rhuMAb VEGF Bevacizumab In Combination With Paclitaxel And Carboplatin In Surgically Resectable 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:
RATIONALE Monoclonal antibodies such as bevacizumab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or deliver cancer-killing substances to them Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die Combining monoclonal antibody therapy with chemotherapy before surgery may may shrink the tumor so that it can be removed
PURPOSE This phase II trial is to see if bevacizumab paclitaxel and carboplatin given before surgery work in treating patients who have stage IB stage II or stage IIIA non-small cell lung cancer
PURPOSE This phase II trial is to see if bevacizumab paclitaxel and carboplatin given before surgery work in treating patients who have stage IB stage II or stage IIIA non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the clinical complete and partial response rate in patients with stage IB II or IIIA resectable non-small cell lung cancer treated with neoadjuvant bevacizumab paclitaxel and carboplatin
Determine the pathologic complete response rate in patients treated with this regimen
Determine the ability to proceed with and complete a potentially curative resection in patients treated with this regimen
Determine the safety and toxicity of this regimen in these patients
OUTLINE Patients receive neoadjuvant bevacizumab IV over 60-90 minutes paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1
Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity
Patients undergo surgical resection within 4-6 weeks after completion of chemotherapy
Patients are followed within 3 months
PROJECTED ACCRUAL A total of 23-39 patients will be accrued for this study
Determine the clinical complete and partial response rate in patients with stage IB II or IIIA resectable non-small cell lung cancer treated with neoadjuvant bevacizumab paclitaxel and carboplatin
Determine the pathologic complete response rate in patients treated with this regimen
Determine the ability to proceed with and complete a potentially curative resection in patients treated with this regimen
Determine the safety and toxicity of this regimen in these patients
OUTLINE Patients receive neoadjuvant bevacizumab IV over 60-90 minutes paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1
Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity
Patients undergo surgical resection within 4-6 weeks after completion of chemotherapy
Patients are followed within 3 months
PROJECTED ACCRUAL A total of 23-39 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 |
|---|---|---|---|
| OSU-0120 | None | None | None |
| UCCRC-12653A | None | None | None |
| NCI-2655 | None | None | None |