A Randomized Double Blind Phase II Study of Preoperative Celecoxib/Paclitaxel/Carboplatin for Stage IIIA Non-Small Cell Lung Cancer
Drugs used in chemotherapy such as paclitaxel and carboplatin use different ways to stop tumour cells from dividing so they stop growing or die. Celecoxib may increase the effectiveness of a chemotherapy drug by making tumour cells more sensitive to the drug, may stop the growth of tumour cells by stopping blood flow to the tumour, and/or may block the enzymes necessary for tumour cell growth. Giving combination chemotherapy with celecoxib before surgery may kill more tumour cells.
This randomized phase II trial is studying how well giving paclitaxel together with carboplatin followed by surgery works compared to giving paclitaxel together with carboplatin and celecoxib followed by surgery in treating patients with stage IIIA non-small cell lung cancer.
This is a randomized, double-blind, multicentre study.
Patients are stratified according to use of aspirin for prior cardiovascular
disease. Patients are randomized to 1 of 2 treatment arms:
In both arms, patients undergo surgical resection and
complete mediastinal lymph node dissection within 3-6 weeks after completion of
chemotherapy. Patients resume oral celecoxib or placebo twice daily within
28-42 days after surgery and continue until 3 years from the date of
randomization in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3-6 months.
View this trial on ClinicalTrials.gov
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