Biomarkers predict response to XELOX and Avastin in mCRC- Version 1.0
Research type
Research Study
Full title
Study of molecular biomarkers to predict response to XELOX (Xeloda/capecitabine and Oxaliplatin) and Avastin (anti-VEGF) therapy in metastatic Colorectal Cancer (mCRC)
IRAS ID
166654
Contact name
You Yone
Contact email
Sponsor organisation
R & D Department
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
We aim to carry out a retrospective study to determine if mutations in the K-ras gene can predict the response of metastatic colorectal cancer to XELOX and Avastin treatment.
XELOX (Xeloda/capecitabine and Oxaliplatin) is a type of chemotherapy often used with Avastin (a biological agent that stops tumour cells receiving nutrients and growing) for treating colorectal cancer (CRC) that has spread (metastatic [mCRC]).The response rate for this combination of treatment is around 45% which means many patients experience long and toxic treatments with limited benefits.
It is essential to find reliable ways (markers) to predict which patients will respond to the therapy before they are given it to avoid unnecessary treatment and potential side effects in those patients who won’t benefit.
This study will investigate genetic changes in the K-ras gene status to see if they can predict the response of mCRC to XELOX and Avastin treatment. K-ras gene status of patient’s tumours has been previously shown to be associated with response to Avastin-containing chemotherapies, however there are conflicting findings reported due to differences in the chemotherapy regimens used with Avastin and experimental methodologies used for analysing K-ras mutations.
We will use tumours from patients who developed mCRC and who were treated with XELOX and Avastin and assess genetic changes in the K-ras gene of these patient’s for changes that may predict response. We will also look at whether any changes in this gene effects the overall survival rates of patients with mCRC. All patients will have consented for their tumours to be used as part of research at Broomfield Hospital, Chelmsford, Essex. This will be a single site study and it is expected to take 4 years to complete (part time).
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
15/LO/1270
Date of REC Opinion
17 Jul 2015
REC opinion
Favourable Opinion