Irofulven in Treating Patients With Relapsed or Refractory Non-small Cell Lung Cancer

Phase 2 Completed 36 enrolled Alliance for Clinical Trials in Oncology National Cancer Institute (NCI) · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients with relapsed or refractory non-small cell lung cancer.

Timeline

Start: 1998-11
Primary completion: 2004-09
Completion: 2006-01

Outcome

Missed primary endpoint

paper RESULTS: Thirty-six patients (15 relapsed; 21 refractory) were treated, and no responses were seen. PMID 15301880 ↗

paper CONCLUSIONS: HMAF, administered at this dose and schedule, is not active as salvage therapy for relapsed or refractory non-small cell lung cancer. PMID 15301880 ↗

Publications

Results Sherman CA, Herndon JE 2nd, Watson DM, Green MR; Cancer and Leukemia Group B. A phase II trial of 6-hydroxymethylacylfulvene (MGI-114, irofulven) in patients with relapsed or refractory non-small cell lung cancer. Lung Cancer. 2004 Sep;45(3):387-92. doi: 10.1016/j.lungcan.2004.02.017.
Results Sherman CA, Herndon JE, Green MR, et al.: CALGB 39805: phase II trial of 6-hydroxymethylacylfulvene (HMAF; MGI-114) in patients with relapsed or refractory non-small cell lung cancer (NSCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 19: A2163, 2000.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	irofulven	Small molecule	11 mg/m2	Intravenous