A phase II study of carboplatin and paclitacel with meloxicam.

BACKGROUND: Cyclooxygenase (COX-2) overexpression is seen in many malignancies including lung cancer. Recent pre-clinical studies have shown that selective COX-2 inhibitors have demonstrated promising results when used with chemotherapy. Based on these observations, we assessed the efficacy and tolerability of the combination chemotherapy consisting of carboplatin and paclitaxel with meloxicam, a selective COX-2 inhibitor.

METHODS: Forty-four patients with stage IIIB or IV non-small cell lung cancer (NSCLC), Eastern Cooperative Oncology Group performance status (PS) 0 or 1, who had adequate organ function, were eligible. Patients received paclitaxel 70 mg/m(2) weekly for 3 of 4 weeks with carbopltin (AUC 6) on day 1, as well as daily meloxicam (10 mg/day). The response rate was the primary endpoint. Secondary endpoints were overall survival, toxicity profile and quality of life (using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and LC13).

RESULTS: From March 2005 to September 2006, 44 patients were evaluated in this study. Gender M/F, 31/13; median age, 64 years (range, 34-75); stage IIIB/IV, 11/33; PS0/1, 22/22; histology Ad/Sq/Other, 29/6/9. Partial response was observed in 19 patients (43%) with stable disease, and there was no complete response, for an overall response rate of 43% (95% confidence interval, 28.5-57.8%). Ten patients (23%) had grade (G) 3 and three (7%) had G4 neutropenia. Three patients (7%) had G3 thrombocytopenia. As for non-hematological toxicities, one case of G4 toxicity (perforation of jejunum) was observed, but other toxicities were mild (one muscle pain, two liver dysfunction, one fatigue and one nausea G3). Grade 2 peripheral neuropathy was observed in only one patient. Using the EORTC QLQ questionnaire, the global health status did not change significantly during this therapy (before and 4 and 8 weeks later). Median follow-up was 13.6 months (range, 1.8-31.3 months). By the time of the final analysis (October 2007), 26 of the initial 44 patients had died. The 1-year survival rate was 64% and median survival time was 15.9 months.

CONCLUSIONS: Meloxicam in combination with carboplatin and weekly paclitaxel chemotherapy showed promising activity with encouraging survival. This therapy is relatively well tolerated in advanced NSCLC.