Phase II study of ASA404 (vadimezan, 5,6-dimethylxanthenone-4-acetic acid/DMXAA) 1800 mg/m2 combined with carboplatin and paclitaxel in previously untreated advanced non-small cell lung cancer

Abstract

This single-arm phase II study evaluated the tumor-vascular disrupting agent ASA404 (vadimezan, 5,6-dimethylxanthenone-4-acetic acid/DMXAA) 1800 mg/m2 plus standard therapy of carboplatin and paclitaxel in patients with advanced non-small cell lung cancer (NSCLC). This ASA404 dose is 50% higher than that used in previous phase II studies. Thirty patients with histologically confirmed stage IIIb or IV NSCLC previously untreated with chemotherapy received carboplatin AUC 6 mg/ml min plus paclitaxel 175 mg/m2 plus ASA404 1800 mg/m2 every 21 days for up to six cycles. The addition of ASA404 1800 mg/m2 to standard therapy produced little change in the systemic exposure of either total or free car..