Adjuvant Xeloda Plus Eloxatin +/- Avastin After Radical Resection of Liver Metastasis of Colorectal Cancer

Phase 3 Terminated 79 enrolled Dutch Colorectal Cancer Group Roche Pharma AG · collab Sanofi · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The primary aim of this study is to investigate whether the addition of the new anti-cancer drug bevacizumab (Avastin) to the combination of the chemotherapeutic agents capecitabine (Xeloda) and oxaliplatin (Eloxatin) reduces (slows down) the recurrence of metastatic disease after a radical resection of liver metastases in patients with colorectal cancer.

Timeline

Start: 2006-12
Primary completion: 2013-08
Completion: 2013-08

Outcome

Outcome not reported

Stopped: “Data from the C08 study and Avant study”

Publications

Snoeren N, Voest EE, Bergman AM, Dalesio O, Verheul HM, Tollenaar RA, van der Sijp JR, Schouten SB, Rinkes IH, van Hillegersberg R. A randomized two arm phase III study in patients post radical resection of liver metastases of colorectal cancer to investigate bevacizumab in combination with capecitabine plus oxaliplatin (CAPOX) vs CAPOX alone as adjuvant treatment. BMC Cancer. 2010 Oct 11;10:545. doi: 10.1186/1471-2407-10-545.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	7.5 mg/kg	—
Comparator	Capecitabine	Small molecule	1000 mg/m2	—
Comparator	Oxaliplatin	Small molecule	130 mg/m2	Intravenous