A Phase II Study Of ZD6474 Or Placebo In Small Cell Lung Cancer Patients Who Have Complete Or Partial Response To Induction Chemotherapy +/- Radiation Therapy
- Compare the progression-free survival of patients with previously treated small cell
lung cancer (SCLC) treated with ZD6474 vs placebo.
- Compare the response rate of patients treated with these regimens (only patients who
had measurable disease outside a prior radiation field at study entry).
- Compare the toxicity and tolerability of these regimens in these patients.
- Compare the pharmacokinetics of these regimens in these patients.
- Correlate outcome and response with vascular endothelial growth factor expression and
microvessel density in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Provide a comprehensive tumor, plasma, and urine bank linked to a clinical database for
further study of molecular markers in SCLC.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to participating center, timing of prior radiotherapy (early
[before day 1, course 4 of chemotherapy] vs late vs no prior radiotherapy), stage of disease
at diagnosis (limited vs extensive), and response at study entry (complete vs partial).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral ZD6474 daily.
- Arm II: Patients receive oral placebo daily. In both arms, courses repeat every 28 days
for up to 2 years in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 4 weeks while on therapy, and then every 8
weeks until disease progression.
Patients are followed every 8 weeks until disease progression and then every 6 months
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Andrew M. Arnold, MD
Margaret and Charles Juravinski Cancer Centre
United States: Food and Drug Administration