A phase II trial of 6-hydroxymethylacylfulvene (MGI-114, irofulven) in patients with advanced non-small cell cancer previously treated with chemotherapy

Purpose: To test the efficacy and safety of the novel antitumor agent MGI-1 14 (NSC 683863) in patients with advanced non-small cell lung cancer (NSCLC ) previously treated with chemotherapy. Methods: A two-stage accrual design was used to ensure detection of a true response rate of at least 20% with a type I error of .04. Eligible patients received 11 mg/m(2) daily for five consecutive days. Cycles were repeated every 28 days. Results: Fifteen pat ients received a total of 34 cycles of MGI-114. All patients had a performa nce status of 0 or 1. Eleven patients had previously received carboplatin a nd paclitaxel +/- radiation. Two patients had received cisplatin and CPT-11 , one patient had received weekly paclitaxel, and one patient had received carboplatin and docetaxel. None of the first 15 patients enrolled experienc ed objective tumor response, and the study was closed. Forty percent of pat ients developed greater than or equal to grade 2 thrombocytopenia. Grade 3 nausea and greater than or equal to grade 2 vomiting were observed in 40% a nd 47% of patients respectively. Thirty-three percent of patients experienc ed greater than or equal to grade 2 fatigue. Conclusions: MGI-114, at this dose and schedule, does not have significant activity as second line therap y for patients with advanced NSCLC.