Phase I/II trial of a COX-2 inhibitor with limited field radiation for intermediate prognosis patients who have locally advanced non-small-cell lung cancer: radiation therapy oncology group 0213.

Treatment of patients who have locally advanced non-small-cell lung cancer and compromised performance status or weight loss (WL) is challenging. This study was conducted to test a low toxicity treatment regimen in this cohort.Patients were treated with concurrent celecoxib and thoracic radiation therapy to 45 Gy in 15 fractions or 60 to 66 Gy in 30 to 33 fractions. Eligible patients had inoperable or unresectable stage IIB, IIIA/B NSCLC, performance status 2 and/or greater than 5% WL. In the phase I portion of the study, the starting dose of celecoxib was 200 mg twice daily with one dose escalation to 400 mg twice daily. Celecoxib was continued for 2 years or until progression.The phase I component accrued eight patients each at 200 mg twice daily and 400 mg twice daily. Twice daily 400 mg was chosen for the phase II component, which enrolled five patients and was closed early because of poor accrual. We were able to analyze 18 patients. Performance status ratings were 0, 1, and 2 in 7, 7, and 4 patients, respectively. Median age was 72 years. WL of greater than 5% was noted in 10 patients (56%). Four of 10 had WL greater than or equal to 20%. Median follow-up and survival was 10 months. Overall survival rates at 1 and 2 years were 44.4% [95% confidence interval (CI), 21.6%-65.1%] and 22.2% (95% CI, 6.9%-42.9%), respectively. Progression-free survival at 1 year was 33.3% (95% CI, 13.7%-54.5%). Toxicities matched those expected with thoracic radiotherapy alone.Concurrent thoracic radiation therapy and celecoxib was well tolerated. The sample size was too small to draw conclusions regarding efficacy.