A phase II study of irinotecan plus chronomodulated oxaliplatin, 5-fluorouracil and folinic acid in advanced colorectal cancer patients.

摘要: The combination of irinotecan (CPT-11), oxaliplatin (L-OHP), 5-fluorouracil (5-FU) and folinic acid (FA) is one the possibilities to overcome chemoresistance in advanced colorectal cancer (ACRC) patients. aim this study was determine tolerability activity CPT-11 plus chronomodulated infusion L-OHP, 5-FU FA ACRC A total 35 patients (91% pretreated, 77% with CPT-11, 54% 42% both) were treated every 3 weeks 180 mg m(-2) day 1 i.v., 20 day(-1), 5-FU, 700 day(-1) FA, 150 all three drugs from 2 5 by infusion. patients' (pt) data as follows: male/female 21/14; median age 58 years (range: 38-70); PS 0: 26 pts (74%), 1: 8 (23%), 2: pt (3%); primary tumour colon/rectum 26/9; involved organs: 1, 14 (40%); 2, 17 (48%); >or=3: 4 (11%); previous chemotherapy lines 12 (34%), 10 (28%), (28%). 221 courses (c) performed; no grade toxicity observed only (G3) neutropenia thrombocytopenia (3%) out (<1%). Maximal nausea diarrhoea occurring c (6%) (5%) respectively. Seven achieved a partial response (20%, confidence interval (c.i.) 6.8-33.3) patient complete (2.9%, c.i. 0-8.4), for overall rate 22.9% (c.i. 9-36.8); 15 (42.9%, 26.5-59.3) had stable disease (34.3%, 18.6-50) underwent progression. In conclusion, four-drug regimen feasible pretreated significant haematological acceptable diarrhoea. currently studied EORTC 05011 study.