A Phase I Pharmacokinetic Interaction Study of Irinotecan (NSC616348) and Thalidomide (NSC66847) in Patients With Advanced Solid Tumors
I. Determine whether thalidomide alters the pharmacokinetics of irinotecan in patients with
advanced solid tumors.
II. Determine whether irinotecan alters the pharmacokinetics of thalidomide in these
III. Determine the toxicity of this regimen in these patients. IV. Determine the observed
antitumor response in patients treated with this regimen.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive irinotecan IV over 90 minutes on days 1 and 22 and oral thalidomide
once daily on days 15-28.
Arm II: Patients receive irinotecan as in arm I and oral thalidomide once daily on days -6
All patients undergo disease re-evaluation at 6 weeks. Patients with stable or responsive
disease may receive additional courses comprising irinotecan IV on day 1 and oral
thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Effect of thalidomide on irinotecan hydrochloride pharmacokinetics
Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|