A Phase I and Pharmacokinetic Study of Selenomethionine With Fixed Dose Irinotecan in Advanced Solid Tumors
- Determine the optimal loading and maintenance doses of selenium necessary to achieve
selenium concentrations exceeding 15 μM when administered with irinotecan in patients
with advanced solid tumors.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the toxic effects of this regimen in these patients.
- Determine any observed tumor response to this regimen in these patients.
OUTLINE: This is a dose-escalation study of selenium.
Patients receive a loading dose* of oral selenium twice daily on days -6 to 0. Patients then
receive oral selenium once daily on days 1-42 and irinotecan IV over 90 minutes on days 1,
8, 15, and 22. Courses repeat every 42 days in the absence of disease progression or
NOTE: *The loading dose is administered prior to course 1 only.
Cohorts of 3-6 patients receive escalating doses of selenium until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
PROJECTED ACCRUAL: A total of 2-36 patients will be accrued for this study within 18 months.
Primary Purpose: Treatment
Maximum tolerated dose
Marwan Fakih, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|