This was a single-arm, multicenter phase II study evaluating activity of weekly alternating 5-FU, CPT-11, BEV and OHP (FIr-B/FOx) as first-line treatment of MCRC.
FIr-B/FOx or "Poker" association consisted of 5-FU associated to alternating CPT-11/BEV or l-OHP according to the following weekly schedule: TFI/5-FU (Fluorouracil Teva®, Teva), 900 mg/m2/die, over 12-hour (from 10:00 p.m to 10:00 a.m.), days 1-2, 8-9, 15-16 and 22-23; CPT-11 (Campto®, Pfizer), 160 mg/m2, administered over 90 minutes as an intravenous infusion in 250 ml of NaCl 0.9%, days 1 and 15; BEV (Avastin®, Roche), 5 mg/kg, administered over 90 minutes at the first, 60 minutes at the second and 30 minutes from the third time, intravenous infusion in 100 ml of NaCl 0.9%, days 1 and 15; l-OHP (Eloxatin®, Sanofi-Aventis) over 2-hours as an intravenous infusion in 250 ml of dextrose 5%, at the dose of 60-70-80 mg/m2, days 8 and 22. Cycles repeated every 4 weeks. 5-FU was administered by a portable pump (CADD Plus, SEVIT) using a venous access device.
FIr-B/FOx or "Poker" association consisted of 5-FU associated to alternating CPT-11/BEV or l-OHP according to the following weekly schedule: TFI/5-FU (Fluorouracil Teva®, Teva), 900 mg/m2/die, over 12-hour (from 10:00 p.m to 10:00 a.m.), days 1-2, 8-9, 15-16 and 22-23; CPT-11 (Campto®, Pfizer), 160 mg/m2, administered over 90 minutes as an intravenous infusion in 250 ml of NaCl 0.9%, days 1 and 15; BEV (Avastin®, Roche), 5 mg/kg, administered over 90 minutes at the first, 60 minutes at the second and 30 minutes from the third time, intravenous infusion in 100 ml of NaCl 0.9%, days 1 and 15; l-OHP (Eloxatin®, Sanofi-Aventis) over 2-hours as an intravenous infusion in 250 ml of dextrose 5%, at the dose of 60-70-80 mg/m2, days 8 and 22. Cycles repeated every 4 weeks. 5-FU was administered by a portable pump (CADD Plus, SEVIT) using a venous access device.
Free full text: Click here
