240
Participants
Start Date
July 31, 2012
Primary Completion Date
November 30, 2018
Study Completion Date
November 30, 2018
FOLFIRI + bevacizumab
"* Bevacizumab 5 mg/kg iv, followed by~* Irinotecan 180 mg/m2 iv administered over a period of 30-90 minutes, followed by~* Leucovorin (LV) 400 mg/m2 iv administered over a period of 2 hours, followed by~* 5-FU 400 mg/m2 iv bolus, followed by~* 5-FU 2,400 mg/m2 for 46 h continuous infusion. This treatment will start on day 1 and will be repeated every 2 weeks (1 cycle)."
FOLFIRI + cetuximab
"* Cetuximab in an initial 120-minute infusion on day 1 of 400 mg/m2, followed by 60-minute infusions of cetuximab at a dose of 250 mg/m2, once weekly~* FOLFIRI:~ * Irinotecan 180 mg/m2 iv administered over a period of 30-90 minutes, followed by~ * Leucovorin (LV) 400 mg/m2 iv administered over a period of 2 hours, followed by~ * 5-FU 400 mg/m2 iv bolus, followed by~ * 5-FU 2,400 mg/m2 for 46 h continuous infusion FOLFIRI will be given after the cetuximab infusion on day 1 of each period (every 2 weeks: 1 cycle)."
Spanish Cooperative Group for Digestive Tumour Therapy, Madrid
Roche Pharma AG
INDUSTRY
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
OTHER