A Phase I Dose Escalation Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Pediatric Patients With Advanced Solid Tumors and Lymphomas
- Determine the maximum tolerated dose of exatecan mesylate (DX-8951f) with and without
filgrastim (G-CSF) in pediatric patients with advanced solid tumors or lymphomas.
- Determine the toxic effects, including dose-limiting toxicity, of exatecan mesylate in
- Determine the pharmacokinetics of exatecan mesylate in these patients.
- Determine the recommended dose of exatecan mesylate for phase II study.
- Determine the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of exatecan mesylate (DX-8951f). Patients are
stratified according to prior treatment (minimally treated vs heavily treated).
Patients receive exatecan mesylate IV over 30 minutes daily for 5 days. Patients in dose
levels 5 and above also receive filgrastim (G-CSF) subcutaneously beginning on day 6 and
continuing for at least 7 days or until blood counts recover. Treatment repeats every 3
weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of exatecan mesylate with and without G-CSF
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting
Patients are followed every 3 months.
PROJECTED ACCRUAL: Approximately 45 patients will be accrued for this study.
Primary Purpose: Treatment
Robert L. DeJager, MD, FACP
Daiichi Sankyo Inc.
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|
|Institute for Drug Development||San Antonio, Texas 78245-3217|
|Children's Medical Center of Dallas||Dallas, Texas 75235|