A Randomized Double Blind Phase II Study of Preoperative Celecoxib/Paclitaxel/Carboplatin for Stage IIIA Non-Small Cell Lung Cancer
- 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.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified
according to use of aspirin for prior cardiovascular disease (yes vs no). 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.
PROJECTED ACCRUAL: A total of 110 patients (55 per treatment arm) will be accrued for this
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Rates of complete pathological response and/or minimal residual microscopic disease at 3 years
Beckman Research Institute
United States: Federal Government
|New York Weill Cornell Cancer Center at Cornell University||New York, New York 10021|
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|