Randomized phase II trial of weekly squalamine, carboplatin, and paclitaxel as first line therapy for advanced non-small cell lung cancer

7109 Background:Squalamine is an anti-angiogenic aminosterol that acts directly within activated endothelial cells and has acivity in cancer and eye angiogenesis models. Previously a Phase I/II trial in advanced non-small cell lung cancer (NSCLC) of a once every three weeks regimen of squalamine (given as a five day infusion at doses of 100 to 400 mg/m2/day) combined with carboplatin (AUC=6) and paclitaxel (225 mg/m2) was reported to give a response rate of 28% in 43 patients, with median survival of 10.0 months and one year survival of 40%. In the current study a weekly “metronomic” dosing approach of the squalamine, carboplatin, and paclitaxel regimen was evaluated. Methods:45 patients with Stage IIIB NSCLC with pleural effusion or Stage IV disease were enrolled. The drug regimen was a weekly three hour infusion of squalamine (patients randomly assigned 1:1 to a dose of 100 or 200 mg/m2)combined with weekly carboplatin (AUC=2) and paclitaxel (75 mg/m2), for 12 weeks. Patients were eligible to receive ad...