CO.20 Study

A Phase III Randomised Study of Brivanib Alaninate (BMS- 582664) in Combination with Cetuximab (ERBITUX®) Versus Placebo in Combination with Cetuximab (ERBITUX®) in Patients With K-Ras Wild Type Tumours Previously Treated with Combination Chemotherapy for Metastatic Colorectal Carcinoma.

Trial Status

Completed

Cancer Type

Colorectal Cancer

Aim

CO.20 will examine the effect of cetuximab and brivanib (BMS-582664)

versus cetuximab alone on overall survival and quality of life in patients with advanced colorectal cancer (K-Ras Wild Type Tumours) who have failed all chemotherapy (including a thymidylate synthase inhibitor, an irinotecan-containing regimen and an oxaliplatin-containing regimen) recommended by their oncologist, and for whom no standard anticancer therapy other than cetuximab is available. Additional assessments will include putative predictive molecular markers, health utility and economic evaluation.

Trial Status

Completed

Cancer Type

Colorectal Cancer

Publication Reference

  1. Ringash J, Au HJ, Siu LL, Shapiro JD, Jonker DJ, Zalcberg JR, Moore MJ, Strickland A, Kotb R, Jeffery M, Alcindor T, Ng S, Salim M, Sabesan S, Easaw JC, Shannon J, El-Tahche F, Walters I, Tu D, O’Callaghan CJ, NCIC Clinical Trials Group, Australasian Gastrointestinal Trials Group. Quality of life in patients with K-RAS wild-type colorectal cancer: the CO.20 phase 3 randomized trial. Cancer 2014; 120(2): 181–189.
  2. Siu L, Shapiro J, Jonker D, Karapetis C, Zalcberg J, Simes J, Couture F, Moore M, Price T, Siddiqui J, Nott L, Charpentier D, Liauw W, Sawyer M, Jefford M, Magoski N, Haydon A, Walters I, Ringash J, Tu D, O’Callaghan C. Phase III randomized, placebo-controlled study of cetuximab plus brivanib alaninate versus cetuximab plus placebo in patients with metastatic, chemotherapy-refractory, wild-type K-RAS colorectal carcinoma: the NCIC Clinical Trials Group and AGITG CO.20 trial. Journal of Clinical Oncology; 31(19): 2477-2484.

Aim

The purpose of this study is to find out whether it is better to receive a new drug, brivanib, in combination with cetuximab, or better to receive only cetuximab for colon or rectal cancer.

Principal Investigator

Dr Jeremy Shapiro, Medical Oncologist, Cabrini Health VIC