A Phase II Open, Multicenter Trial to Assess the Activity and Tolerability of ZD0473 Given Intravenously as Second-Line Therapy to Patients With Non-Small Lung Cancer Who Have Failed One Prior Platinum Based Chemotherapy Regimen
OBJECTIVES: I. Determine the anti-tumor effect of ZD0473 in patients with progressive or
relapsed non-small cell lung cancer who have failed first-line platinum-based chemotherapy.
II. Assess the safety and tolerability of this drug in these patients. III. Determine the
pharmacokinetics of this drug in these patients. IV. Determine the efficacy of this drug, in
terms of time to death, time to disease progression, disease control, and duration of
response, in these patients. V. Assess the therapy outcome index, in terms of
disease-related symptom relief, of these patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to time to relapse
or progression after completion of first-line platinum-based chemotherapy (12 weeks or less
vs more than 12 weeks). Patients receive ZD0473 IV over 1 hour on day 1. Treatment repeats
every 21 days for up to 6 courses in the absence of disease progression or unacceptable
toxicity. Quality of life is assessed at baseline, at the beginning of each course, and then
every 6 weeks for 1 year after completion of study. Patients are followed at 30 days after
study completion and every 6 weeks for 1 year.
PROJECTED ACCRUAL: A total of 32-73 patients (23-56 per stratum 1 and 9-17 per stratum 2)
will be accrued for this study within approximately 9 months.
Primary Purpose: Treatment
Robert A. Figlin, MD, FACP
Jonsson Comprehensive Cancer Center
United States: Federal Government