A PHASE I STUDY OF PROLONGED LOW-DOSE TOPOTECAN INFUSION COMBINED WITH CHEST IRRADIATION
I. Determine the maximum tolerated dose of topotecan and chest irradiation in patients with
non-small cell lung cancer.
II. Determine the qualitative and quantitative toxic effects of this regimen in these
III. Determine the degree of antitumor activity of this regimen in these patients.
OUTLINE: This is a dose escalation study of topotecan and thoracic radiotherapy.
Beginning on day 1, patients receive topotecan IV continuously for 3-6 weeks and thoracic
radiotherapy 5 days a week for 2, 3, or 6 weeks. Cohorts of 4-6 patients receive escalating
doses of topotecan and thoracic radiotherapy until the maximum tolerated dose (MTD) of each
therapy is determined. The MTD is defined as the dose preceding that at which 2 of 4 or 6
patients experience dose-limiting toxicity. Six additional patients are treated at the MTD.
Patients who fail to achieve complete remission (CR) and continue to have measurable disease
at 4-6 weeks after completion of radiotherapy receive topotecan IV continuously on days 1-21
at 1 dose level preceding the MTD as determined by the ongoing Protocol NYU-9123. Treatment
continues every 4 weeks in the absence of unacceptable toxicity.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Howard S. Hochster, MD
New York University School of Medicine
United States: Food and Drug Administration
|NYU School of Medicine's Kaplan Comprehensive Cancer Center||New York, New York 10016|