Brivanib and Cetuximab versus Cetuximab and Placebo in treating patients with metastatic colorectal cancer who have been previously treated with combination chemotherapy

Phase 3

Recruiting

• Conditions: Metastatic Colorectal Cancer; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12607000589482
• Lead Sponsor: Australasian Gastro-Intestinal Trials Group (AGITG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

Age > 18 years Histologically confirmed metastatic colorectal cancer Confirmed K-Ras wild type tumour Previously treated with thymidylate synthase inhibitor Previously failed treatment with irinotecan-containing regimen and oxaliplatin-containing regimen where failure is defined as either progression of disease or intolerance to the regimen due to severe allergic reaction or delayed recovery from toxicity. Measurable or evaluable disease Minimum 4 weeks have elapsed since recent surgery, chemotherapy, treatment with another investigational agent, or radiation therapy ECOG performace status of 0, 1, or 2 Provision of blood/tumor speciments for correlative studies

Exclusion Criteria

K-Ras mutant, indeterminate, or no tumour tissue available for testing History of other malignancies other than non-melanoma skin cancer, in-situ cancer of the cervix, or other curatively treated solid tumors with no evidence of disease for > 5 years Any active disease condition which would render protocol treatment dangerous or does not permit compliance with protocol Uncontrolled or significant cardiovascular disease, hypertension, or a history of thromboembolic event in last 6 months Central nervous system metastases Prior treatment with Cetuximab or other EGFR (epidermal growth factor receptor) pathway targetting agent or murine monoclonal antibody

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the overall survival of patients with previously treated metastatic colorectal cancer treated with Brivanib in combination with Cetuximab with those treated with placebo and Cetuximab[At interim analysis point (ie: > 263 deaths) and end of study]

Secondary Outcome Measures

Name	Time	Method
Compare progression-free survival in both treatment groups<br>Compare objective response rate and duration of response in both treatment groups.<br>Compare quality of life in both treatment groups.<br>Compare health utilities in both treatment groups.<br>Conduct a comparative economic evaluation of both treatment groups.<br>Evaluate safety profile of Cetuximab and Brivanib and Cetuximab alone in this patient population.[At end of study]