NCT00004151

Acridine Carboxamide in Treating Patients With Advanced Non-small Cell Lung Cancer

Open Label Phase II Study on XR5000 Administered as a 5 Day Infusion in Advanced Non Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 acridine carboxamide in treating patients who have advanced non-small cell lung cancer that cannot be treated with surgery.

Detailed description

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	acridine carboxamide

Timeline

• Start date: 1999-09-01
• Primary completion: 2000-11-01
• First posted: 2004-03-15
• Last updated: 2012-09-24

Locations

8 sites across 6 countries: Austria, Denmark, France, Germany, Italy, Spain