47
Participants
Start Date
June 30, 2006
Primary Completion Date
December 31, 2010
Study Completion Date
February 28, 2015
Capecitabine
"Capecitabine 1700mg/m2/day in two divided doses to be administered orally for 14 days followed by 7 days rest. For 4 courses initially.~(For patients aged 75+ 1300mg/m2/day in two divided doses or 650mg/m2 twice daily)~Courses as per detailed description above."
Oxaliplatin
"Oxaliplatin 130mg/m2 diluted in 5% dextrose will be given as an i.v. infusion over 2 hours. This will be administered on day 1 after bevacizumab. For 4 courses.~(Patients aged 75+ should receive oxaliplatin at a reduced dose i.e. 100mg/m2)~Courses as per detailed description above."
Bevacizumab
"Bevacizumab at a dose of 7.5 mg/kg, diluted in normal saline, will be administered as an iv infusion over 30 to 90 minutes before the administration of oxaliplatin on day 1 of every cycle.~The first infusion should be administered over 90 minutes. If well tolerated, the second infusion can be administered over 60 minutes. Provided that this is tolerated subsequent infusions can be administered over 30 minutes. If a patient experiences an infusion related adverse event with the 60 minute infusion, all subsequent infusions will be administered over 90 minutes. If a patient experiences an infusion related reaction with the 30 minute infusion, all subsequent infusions will be administered over 60 minutes~Courses as per detailed description above."
Liver metastasectomy
Patients with liver metastases which have become resectable and in whom surgery is still deemed appropriate should proceed to surgery after a 6 week interval from the last administration of capecitabine chemotherapy (at least 8 weeks from last administration of bevacizumab).
David Cunningham, Sutton
Roche Pharma AG
INDUSTRY
Royal Marsden NHS Foundation Trust
OTHER