Acridine Carboxamide in Treating Patients With Advanced Non-small Cell Lung Cancer
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 acridine carboxamide in treating patients who have advanced non-small cell lung cancer that cannot be treated with surgery.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Open Label Phase II Study on XR5000 Administered as a 5 Day Infusion in Advanced Non Small Cell Lung Cancer|
|Study Start Date:||September 1999|
|Primary Completion Date:||November 2000 (Final data collection date for primary outcome measure)|
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.
|Kaiser Franz Josef Hospital|
|Vienna, Austria, A-1100|
|Copenhagen, Denmark, 2100|
|Centre de Lute Contre le Cancer,Georges-Francois Leclerc|
|Dijon, France, 21079|
|CHU de la Timone|
|Marseille, France, 13385|
|Haemato-Onkologische Praxis und Tagesklinik|
|Munich, Germany, D-80639|
|Istituto Nazionale per lo Studio e la Cura dei Tumori|
|Naples, Italy, 80131|
|Istituti Fisioterapici Ospitalieri - Roma|
|Rome, Italy, 00161|
|Hospital Universitario 12 de Octubre|
|Madrid, Spain, 28041|
|Study Chair:||Axel R. Hanauske, MD, PhD, MBA||Haemato-Onkologische Praxis und Tagesklinik|