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 ofthe novel antitumor agent MGI-114 (NSC 683863) in patientswith advanced non-small cell lung cancer (NSCLC) previouslytreated with chemotherapy. Methods: A two-stageaccrual design was used to ensure detection of a true responserate of at least 20% with a type I error of .04.Eligible patients received 11 mg/m2 daily for fiveconsecutive days. Cycles were repeated every 28 days.Results: Fifteen patients received a total of 34cycles of MGI-114. All patients had a performance status of 0or 1. Eleven patients had previously received carboplatin andpaclitaxel +/− radiation. Two patients had receivedcisplatin and CPT-11, one patient had received weeklypaclitaxel, and one patient had received carboplatin anddocetaxel. None of the first 15 patients enrolled experiencedobjective tumor response, and the study was closed. Fortypercent of patients developed ≥ grade 2 thrombocytopenia.Grade 3 nausea and ≥ grade 2 vomiting were observed in40% and 47% of patients respectively.Thirty-three percent of patients experienced ≥ grade 2fatigue. Conclusions: MGI-114, at this dose andschedule, does not have significant activity as second linetherapy for patients with advanced NSCLC.