Lung Cancer Clinical Trial
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
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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