Phase II Randomized Study Evaluting the Effect of Celecoxib as Maintenance Treatment of Stage IIIb Non-Small Cell Lung Cancer That Reponded or is Stable After Radiochemotherapy
- Compare the time to progression in patients with stage II-IIIB non-small cell lung
cancer treated with celecoxib vs observation after treatment with chemoradiotherapy.
- Compare the 2-year survival rate of patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare weight changes and objective response in patients treated with these regimens.
- Compare tolerability of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, ECOG performance status (0-1 vs 2), and total dose of radiotherapy (65
Gy vs 60 Gy).
All patients undergo radiotherapy 5 days a week for 7.5 weeks. Patients also receive
docetaxel IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Three weeks after the
completion of radiotherapy, patients receive docetaxel alone IV over 30 minutes on days 1
and 22. Three weeks later, patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients are observed every 3 months for 1 year and then every 6 months for 1
- Arm II: Patients receive oral celecoxib twice daily for up to 2 years in the absence of
disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 3 months for 1 year, and then every 6 months
for 1 year.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Time to progression
Jean F. Morere, MD
United States: Federal Government