Time Finding Study of Chronomodulated Irinotecan, 5 Fluorouracil, Leucovorin and Oxaliplatin as First or Second Chemotherapy Line Against Metastatic Colorectal Cancer
- Determine the role of peak delivery time on the tolerability of irinotecan when
administered with chronomodulated fluorouracil, leucovorin calcium, and oxaliplatin as
first- or second-line therapy in patients with locoregional or metastatic colorectal
- Determine the antitumor activity of this regimen.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, WHO performance status (0-1 vs 2), and line of treatment (first vs
second). Patients are randomized to receive irinotecan at 1 of 6 different times of the day.
Patients receive irinotecan IV over 6 hours on day 1 and fluorouracil IV and leucovorin
calcium IV over 11 hours followed by oxaliplatin IV over 11 hours on days 2-5. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 4 weeks until disease progression and then every 8 weeks
PROJECTED ACCRUAL: A maximum of 186 patients (31 per irinotecan administration time) will be
accrued for this study within 2 years.
Allocation: Randomized, Primary Purpose: Treatment
Peak delivery time for CPT11 tolerability over the first 3 courses of treatment in patients who started therapy
Carlo Garufi, MD
Istituti Fisioterapici Ospitalieri - Roma
United States: Federal Government