None listed
Conditions
Brief 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.
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
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.
Sponsors
Australasian Gastro-Intestinal Trials Group (AGITG)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed