A phase I study of imexon in combination with docetaxel (DOC) for the treatment of patients with breast, lung and prostate cancer

3589 Background: Imexon (IMX) is a 111 mw cyanoaziridine which induces pro-oxidative apoptotic cell death and is synergistic with several classes of agents including taxanes. Methods: A phase I dose escalation study was conducted in 29 previously treated breast (10), lung (9) and prostate (10) cancer patients (Pts), 10 were previously treated with DOC/DOC adjuvant; 4 also had paclitaxel. DOC dose was 75 mg/m2 on day 1 and escalating doses of IMX from 390–1700 mg/m2 were given on days 1–5 Q3W to cohorts of 3–6 patients. Results: Median age was 61.2 years and median # of prior regimens was 4.1 (1–10). The MTD was 75 mg/m2 DOC and 1,300 mg/m2 IMX. Dose limiting toxicity at 1,700 mg/m2 IMX was transient, grade 3–4 non cardiac chest pain (w/o enzyme elevations or EKG changes) in 3/3 pts with pulmonary metastases. Other toxicities due to DOC were nausea, vomiting and neutropenia. Of the 29 pts 22 were evaluable for response with a PR rate of 14% (2 pts with NSCLC, 1 pt with prostate). 1 pt with breast cancer ha...