OBELIX Study: A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Cancer of the Colon or Rectum.

Summary

This single arm study will evaluate the efficacy and safety of a first-line regimen of Avastin and XELOX (oxaliplatin + Xeloda) in patients with metastatic cancer of the colon or rectum. Patients will receive 21-day cycles of treatment, comprising Avastin 7.5mg/kg iv on day 1, oxaliplatin 130mg/m2 iv on day 1, and Xeloda 1000mg/m2 po twice daily on days 1-14, for a maximum of 6 months. Patients with stable disease or complete or partial response may continue on Avastin therapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Timeline

Start

2008-02

Primary completion

2011-08

Completion

2011-08

Publications

• Antonuzzo L, Giommoni E, Pastorelli D, Latiano T, Pavese I, Azzarello D, Aieta M, Pastina I, Di Fabio F, Bertolini A, Corsi DC, Mogavero S, Angelini V, Pazzagli M, Di Costanzo F. Bevacizumab plus XELOX as first-line treatment of metastatic colorectal cancer: The OBELIX study. World J Gastroenterol. 2015 Jun 21;21(23):7281-8. doi: 10.3748/wjg.v21.i23.7281.

Drugs

Indications