Brivanib and Cetuximab versus Cetuximab and Placebo in treating patients with metastatic colorectal cancer who have been previously treated with combination chemotherapy
Phase III randomised study of Brivanib Alaninate (BMS-582664) in combination with Cetuximab (Erbitux 'Registered trade mark') versus placebo in combination with Cetuximab (Erbitux 'Registered trade mark') in patients with K-Ras wild type tumours previously treated with combination chemotherapy for metastatic colorectal carcinoma to compare overall survival.
Australasian Gastro-Intestinal Trials Group (AGITG)
750 participants
Mar 26, 2008
Interventional
Conditions
Summary
This study is assessing two different chemotherapy treatments – Brivanib and Cetuximab versus Cetuximab and standard treatment – in treating people with metastatic (secondary distant) colorectal (K-Ras Wild Type) cancer who have previously been treated with combination chemotherapy. Who is it for? You can join this study if you have completed the standard chemotherapy for metastatic colorectal cancer. Trial details Participants will be randomly divided into two groups. One group will receive a combination of a compound known as oral Brivanib in combination with Cetuximab; the other will receive standard treatment in combination with Cetuximab. The trial will eventually assess if there is a difference in overall survival between the two groups. Brivanib blocks a compound known as ‘vascular endothelial growth factor receptor 2’ (VEGFR2) and this may result in the inhibition of tumour blood vessel growth. Cetuximab blocks another factor called the ‘epidermal growth factor receptor’ (EGFR) and so inhibits cell growth. If your cancer has increased in size on standard treatment for metastatic colorectal cancer (which might included 5-fluorouracil, oxaliplatin and irinotecan), your treatment options are limited. Cetuximab works in this setting but it is not part of the standard treatment. This purpose of this trial is to test if the combination of Brivanib and Cetuximab versus Cetuximab alone improve survival if the treatment you have been receiving has not worked.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
This ia a randomised, double-blind, multicentre study. Patients will be stratified by centre and ECOG (Eastern Cooperative Oncology Group) perfomance status (ie: 0 or 1 versus 2) into one of two treatment arms. Arm I: Patients will receive Brivanib 800mg orally daily, in addition to an initial loading dose infusion of Cetuximab (Erbitux) 400mg/m2 over 120 minutes. Thereafter, patients will receive weekly maintenance infusions of Cetuximab 250mg/m2 over 60 minutes. Arm II: Patients will receive placebo orally daily, and an initial loading dose of Cetuximab 400mg/m2 IV over 120 minutes. Thereafter, the patients will receive a weekly maintenance infusion of Cetuximab 250mg/m2 IV over 60 minutes.
Locations(3)
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ACTRN12607000589482