Triplet schedule of weekly 5-Fluorouracil and alternating irinotecan or oxaliplatin in advanced colorectal cancer: A dose-finding and phase II study

摘要: A weekly administration of alternating irinotecan or oxaliplatin associated to 5-Fluorouracil in advanced colorectal cancer was planned order evaluate a new schedule maintaining dose intensities each drug as double combinations and tolerability the triplet association. The following administered: irinotecan, days 1 15; oxaliplatin, 8 22; 5-fluorouracil (5-FU) over 12-h (from 10:00 p.m. a.m.) timed flat infusion, 1-2, 8-9, 15-16 22-23, every 4 weeks. Dose- finding phase II study were planned. Thirteen patients enrolled dose-finding 23 study. recommended doses our are: 160 mg/m(2); 80 5-FU 900 mg/m(2). dose-limiting toxicity diarrhea (35% patients) but no cases febrile neutropenia observed. In 30 assessable for response two complete (6.7%) 18 partial (60%) responses observed, an overall rate 66.7% (alpha 0.05, CI+/-17). association using this is active well-tolerated outpatient regimen. Surgical removal residual disease considered 5 radical resection performed (147 %).