A phase II trial of 6-hydroxymethylacylfulvene (MGI-114, irofulven) in patients with relapsed or refractory non-small cell lung cancer.


Journal Article

PURPOSE: To assess the efficacy and toxicity of 6-hydroxymethylacylfulvene (HMAF; MGI-114, irofulven) as therapy for relapsed or refractory non-small cell lung cancer. METHODS: A two-stage phase II design was employed separately for refractory and relapsed patients to differentiate between ineffective treatment (response rate < or =10%) and active treatment (response rate > or =30%). Eligible patients received HMAF 11 mg/m2 per day intravenously over 5 min on days 1-5, with cycles repeated every 28 days. RESULTS: Thirty-six patients (15 relapsed; 21 refractory) were treated, and no responses were seen. TOXICITY: Grade 3 neutropenia and grade 3 thrombocytopenia each occurred in 11% of the patients. Grade 3 nausea occurred in 47%; grade 3-4 vomiting in 42%. Twenty-two percent developed grade 3 fatigue. Eleven percent developed grade 3 hallucinations. CONCLUSIONS: HMAF, administered at this dose and schedule, is not active as salvage therapy for relapsed or refractory non-small cell lung cancer.

Full Text

Duke Authors

Cited Authors

  • Sherman, CA; Herndon, JE; Watson, DM; Green, MR; Cancer and Leukemia Group B,

Published Date

  • September 2004

Published In

Volume / Issue

  • 45 / 3

Start / End Page

  • 387 - 392

PubMed ID

  • 15301880

Pubmed Central ID

  • 15301880

International Standard Serial Number (ISSN)

  • 0169-5002

Digital Object Identifier (DOI)

  • 10.1016/j.lungcan.2004.02.017


  • eng

Conference Location

  • Ireland