NCT00005091

DX-8951f in Treating Previously Untreated Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Stage IIIb or Stage IV Non-Small Cell Lung Cancer as First Line Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Daiichi Pharmaceuticals · Industry
• 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 DX-8951f in treating patients who have previously untreated stage IIIB or stage IV non-small cell lung cancer.

Detailed description

OBJECTIVES: I. Determine the antitumor activity of DX-8951f in previously untreated patients with stage IIIB or IV non-small cell lung cancer. II. Evaluate the quantitative and qualitative toxic effects of this regimen in these patients. III. Evaluate the pharmacokinetics of this regimen in these patients. IV. Assess the time to progression and survival status of these patients. OUTLINE: This is a multicenter study. Patients receive DX-8951f IV over 30 minutes daily 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 3 months for survival. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	exatecan mesylate

Timeline

• Start date: 1999-02-01
• Completion: 2003-08-01
• First posted: 2004-06-08
• Last updated: 2013-07-10

Locations

6 sites across 5 countries: Finland, Germany, Italy, Netherlands, United Kingdom