A PHASE I STUDY OF PROLONGED LOW-DOSE TOPOTECAN INFUSION COMBINED WITH PACLITAXEL (TAXOL)
I. Determine the maximum tolerated dose and quantitative and qualitative toxic effects of
topotecan and paclitaxel in patients with solid tumors.
II. Determine the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose escalation study of topotecan and paclitaxel.
Patients receive paclitaxel IV over 3 hours on day 1 followed 2-6 hours later by topotecan
IV continuously on days 1-14. Courses repeat every 3 weeks in the absence of disease
progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of topotecan and paclitaxel until the
maximum tolerated dose (MTD) of each drug is determined. The MTD is defined as the highest
dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 10-20 patients will be accrued for this study within 8-12
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|