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

Lung Cancer Clinical Trial

Official title:
Phase II Trial of 6-Hydroxymethylacylfulvene (HMAF; MGI-114) in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer

Clinical Trial 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.

Clinical Trial Description

OBJECTIVES: I. Determine the response rate to 6-hydroxymethylacylfulvene (HMAF) as salvage chemotherapy in patients with relapsed or refractory non-small cell lung cancer. II. Determine the duration of response to this regimen in this patient population. III. Determine the effect of prior response to chemotherapy on the response to HMAF in these patients. IV. Determine the survival and failure-free survival of patients treated with HMAF. V. Evaluate the toxicity profile of HMAF as salvage therapy in these patients.

OUTLINE: Patients are stratified into relapsed or refractory patient groups based on results achieved with prior therapy. Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes daily for 5 days. Courses repeat every 28 days. Patients with stable or responding disease are treated for a minimum of 6 courses (2 courses beyond optimal response) in the absence of unacceptable toxic effects or disease progression. Patients are followed at least every 3 months for 1 year, then every 6 months until death.

PROJECTED ACCRUAL: A total of 66 patients (33 for each stratum) will be accrued for this study within 12-18 months. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00003666
Study type Interventional
Source Alliance for Clinical Trials in Oncology
Contact
Status Completed
Phase Phase 2
Start date November 1998
Completion date January 2006
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