Paclitaxel and Carboplatin With or Without Celecoxib Before Surgery in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer

Official Title

A Randomized Double Blind Phase II Study of Preoperative Celecoxib/Paclitaxel/Carboplatin for Stage IIIA Non-Small Cell Lung Cancer

Summary:

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.

Trial Description

Primary Outcomes:

• Rates of complete pathological response and/or minimal residual microscopic disease at 3 years  
  

Secondary Outcomes: 

• Clinical response at 3 years
• Difference in time to progression, disease-free survival, and overall survival between Arm I and Arm II at 3 years

Objectives:

• Compare the complete pathological response rate and/or minimal residual microscopic disease in patients with stage IIIA non-small cell lung cancer treated with preoperative paclitaxel and carboplatin with vs without celecoxib.
• Compare the clinical response rate in patients treated with these regimens.
• Compare chemotherapy-related toxicity in patients treated with these regimens.
• Compare the time to progression, disease-free survival, and overall survival of patients treated with these regimens.

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:

• Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on days 1, 22, and 43. Patients also receive oral celecoxib twice daily beginning on day 1 and continuing until the morning of surgical resection.
• Arm II: Patients receive paclitaxel and carboplatin as in arm I and an oral placebo twice daily beginning on day 1 and continuing until the morning of surgical resection.

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