Phase II study of celecoxib and docetaxel in non-small cell lung cancer (NSCLC) patients with progression after platinum-based therapy.

ABSTRACT

INTRODUCTION: To evaluate the efficacy and toxicity of the combination of celecoxib and docetaxel in patients with advanced non-small cell lung cancer after failure of platinum-based therapy. METHODS: Patients with relapsed non-small cell lung cancer received celecoxib 400 mg orally twice daily beginning 7 days before the first cycle of docetaxel and the celecoxib was continued with no interruption. Docetaxel 75 mg/m2 was administered intravenously on a 21-day cycle. The primary end point of the study was the 6-month survival rate. RESULTS: Twenty-four patients were enrolled and twenty patients were treated (median age 60, MF 168). Most patients had a baseline performance status of 1. The objective response rate was 10% (95% confidence interval [CI], 0-25%) and the 6-month survival rate was 59% (95% CI 37-80%). Median survival time was 6.9 months (95% CI, 2.8-15.2 months) and the 1- and 2-year survival rates were 36% (95% CI, 15-57%) and 1% (95% CI, 0-10%), respectively. The most frequent grade > or =3 adverse events were neutropenia (58%) and neutropenic fever (21%) which resulted in early closure of the trial. CONCLUSIONS: The addition of celecoxib to docetaxel did not seem to improve the response rate and survival compared with docetaxel alone. The combination demonstrated considerable neutropenia and complications from febrile neutropenia that suggests celecoxib may enhance the marrow toxicity of docetaxel.