Bevacizumab, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
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.
Procedure: conventional surgery
Procedure: neoadjuvant therapy
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Response Rate (complete and partial responses by RECIST) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2001|
|Study Completion Date:||August 2007|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
Experimental: Arm A
Bevacizumab (15mg/kg, q3wk x 2), Paclitaxel (200 mg/m2, q3wk x 2), carboplatin (AUC of 6, q3wk x 2), followed by surgery 4 to 6 weeks after last dose of Bevacizumab
|Biological: bevacizumab Drug: carboplatin Drug: paclitaxel Procedure: conventional surgery Procedure: neoadjuvant therapy|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025389
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University|
|Columbus, Ohio, United States, 43210|
|Study Chair:||Ann M. Mauer, MD||University of Chicago|