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

Jonathan E. Dowell, David H. Johnson, John S. Rogers, Yu Shyr, Nancy Mccullough, Peggy Krozely, Russell F. DeVore

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

Purpose: To test the efficacy and safety of the novel antitumor agent MGI-114 (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/m2 daily for five consecutive days. Cycles were repeated every 28 days. Results: Fifteen patients received a total of 34 cycles of MGI-114. All patients had a performance status of 0 or 1. Eleven patients had previously received carboplatin and 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 experienced objective tumor response, and the study was closed. Forty percent of patients developed ≥ grade 2 thrombocytopenia. Grade 3 nausea and ≥ grade 2 vomiting were observed in 40% and 47% of patients respectively. Thirty-three percent of patients experienced ≥ grade 2 fatigue. Conclusions: MGI-114, at this dose and schedule, does not have significant activity as second line therapy for patients with advanced NSCLC.

Original languageEnglish
Pages (from-to)85-88
Number of pages4
JournalInvestigational New Drugs
Volume19
Issue number1
DOIs
Publication statusPublished - 2001 Mar 24

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pharmacology
  • Pharmacology (medical)

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