CHRONOMODULATED INFUSION OF 5-FLUOROURACIL, FOLINIC ACID AND CARBOPLATIN IN COLORECTAL-CANCER - A PILOT-STUDY

We investigated if chronomodulated il?fusion of fluorouracil, folinic acid in combination with carboplatin shows antitumor efficacy in patie nts advanced metastatic colorectal cancel: Thirteen patients entered i nto the study. Each treatment cycle consisted of a 5 day course of con tinuous venous infusion of 5-flourouracil (5-FU; 500 mg/m(2)/die), fol inic acid (FA; L-form, 150 mg/m(2)/die) and carboplatin (CBDCA; the do se being calculated according to the Calvert's formula). Patients rece ived the drugs according to the circadian-modified infusion schedule w ith a sinusoidally modulated delivery with peak flow rate at 4.00 AM f or 5-FU and FA and 4.00 PM for CBDCA. Overall a total number of 54 cyc les were administered. Two partial responses and one minor response we re observed among the 5 untreated patients. Five patients had progress ion of disease. Stabilization of previously progressive disease was ob tained in the 5 remaining patients. These preliminary results show tha t the combination of 5-FU, FA and CBCDA infused at circadian-modulated rate has moderate activity in colorectal cancer, specially in previou lsy untreated patients, with a mild and acceptable toxicity.