Phase I trial of imexon and docetaxel in patients with previously treated stage IV non small cell lung cancer, metastatic breast cancer or hormone refractory prostate cancer.

LB-351Background: Imexon (IMX) is an aziridine-containing small molecule that binds to thiols and induces pro-oxidative apoptotic effects in tumor cells. Combination drug studies in vitro showed that several classes of cytotoxic agents were synergistic with IMX, including the taxane-based agent, docetaxel. Methods: Phase I, dose-escalation trial (3 + 3 design) in patients with advanced, previously-treated solid tumors that are known to be sensitive to taxanes. Successive cohorts of patients were treated with escalating doses of IMX, IV over 30 minutes on days 1-5 with a single IV dose of docetaxel on day 1; Q3W, starting docetaxel at 75 mg/m2, with de-escalation steps to 65 mg/m2 and to 55 mg/m2, if necessary for toxicity. Results: A total of 18 patients (non-small cell lung cancer (NSCLC: n = 6), metastatic breast cancer (n = 7), and hormone-refractory prostate cancer (n = 5) have been enrolled so far. Their median …