Capecitabine and Oxaliplatin Plus Bevacizumab as Neoadjuvant Treatment for Untreated Unresectable Liver-only Metastases From Colorectal Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

June 30, 2006

Primary Completion Date

December 31, 2010

Study Completion Date

February 28, 2015

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

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."

DRUG

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."

DRUG

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."

PROCEDURE

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).

Trial Locations (1)

SM2 5PT

David Cunningham, Sutton

All Listed Sponsors
collaborator

Roche Pharma AG

INDUSTRY

lead

Royal Marsden NHS Foundation Trust

OTHER

NCT01022541 - Capecitabine and Oxaliplatin Plus Bevacizumab as Neoadjuvant Treatment for Untreated Unresectable Liver-only Metastases From Colorectal Cancer | Biotech Hunter | Biotech Hunter