5-Flourouracil Preceded by Irinotecan In Patients With Advanced Solid Tumors: A Pilot Study
- Determine the optimal dose of irinotecan when administered before fluorouracil in
patients with advanced solid tumors.
- Determine the toxic effects of this regimen in these patients.
- Correlate the pharmacokinetics of irinotecan with its biologic effects in these
- Assess, in a preliminary manner, the antitumor activity of this regimen in these
OUTLINE: This is a dose de-escalation study of irinotecan.
Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22 and fluorouracil IV
over 5 minutes on days 2, 9, 16, and 23. Treatment repeats every 6 weeks in the absence of
disease progression or unacceptable toxicity.
Cohorts of 6 patients receive decreasing doses of irinotecan until the optimal dose is
determined. The optimal dose is defined as the dose at which at least 3 of 6 patients show
evidence of recruitment of cells into the S phase at 24 hours after irinotecan
PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 12-18
Primary Purpose: Treatment
Patrick J. Creaven, MBBS, PhD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|