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
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.
Primary Purpose: Treatment
Nick Thatcher, PhD, FRCP
Christie Hospital NHS Foundation Trust
United States: Federal Government