Open Label Phase II Study on XR5000 Administered as a 5 Day Infusion in Advanced Non Small Cell Lung Cancer
OBJECTIVES: I. Determine the effect of acridine carboxamide on objective response, response
rate, and duration of response in patients with unresectable, locally advanced, progressive
or metastatic non-small cell lung cancer. II. Determine the toxicities and pharmacokinetics
of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive acridine carboxamide IV over 24 hours
for 5 days. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of
disease progression or unacceptable toxicity. Patients are followed every 6 weeks until
disease progression or commencement of another treatment.
PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Axel R. Hanauske, MD, PhD, MBA
Study Chair
Haemato-Onkologische Praxis und Tagesklinik
United States: Federal Government
EORTC-16991N
NCT00004151
September 1999
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