A Study of Avastin (Bevacizumab) in Combination With mFOLFOX-6 or FOLFOXIRI in Patients With Metastatic Colorectal Cancer.
Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
Participant gender:
Summary
This 2 arm study will compare the resection rate of liver metastases and safety of surgery in
patients with metastatic colorectal cancer and primarily unresectable liver metastases
receiving treatment with Avastin in combination with 5-FU, leucovorin and oxaliplatin with
irinotecan (FOLFOXIRI) or without irinotecan (mFOLFOX-6) as first line treatment. Patients
will be randomized to receive Avastin (5mg/kg iv every 2 weeks) in combination with each of
these two standard neoadjuvant chemotherapy regimens. The anticipated time on study treatment
is until surgery, disease progression, unacceptable toxicity or patient refusal, and the
target sample size is <100 individuals.