RecruitingPhase 3ACTRN12607000589482

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.


Sponsor

Australasian Gastro-Intestinal Trials Group (AGITG)

Enrollment

750 participants

Start Date

Mar 26, 2008

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called Brivanib to a standard treatment called Cetuximab can help people with advanced colorectal (bowel) cancer live longer compared to Cetuximab alone. This type of cancer has spread to other parts of the body and has already been treated with standard chemotherapy, which is no longer working. Cetuximab blocks a protein that helps cancer cells grow. Brivanib blocks blood vessel growth that feeds the tumour. Together, they may be more effective. You may be eligible if: - You are 18 years of age or older - You have confirmed metastatic colorectal cancer that is K-Ras wild type (a specific tumour type) - You have already received and failed standard chemotherapy regimens including irinotecan and oxaliplatin - Your cancer can be measured or evaluated on scans - Your performance status allows you to be reasonably active (ECOG 0, 1, or 2) You may NOT be eligible if: - Your tumour has a K-Ras mutation - You have had prior treatment with Cetuximab or similar drugs targeting EGFR - You have uncontrolled heart disease, hypertension, or a recent blood clot - You have brain metastases - You have another active cancer diagnosis Talk to your doctor about whether this trial might be right for you.

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 treat

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)

New Zealand

Singapore

Canada

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