TRAVASTIN-1. Protocol version 2.0 03.03.2009

• Research type

  Research Study

• Full title

  An assessment of imaging and circulating biomarkers in patients with metastatic colorectal carcinoma treated with the Anti-VEGF monoclonal antibody Bevacizumab

• IRAS ID

  15177

• Contact name

  Suzanne Rowland

• Sponsor organisation

  Christie Hospital NHS Foundation Trust

• Eudract number

  2009-011377-33

• Research summary

  The standard UK treatment for bowel cancer that has spread to other parts of the body's chemotherapy with oxaliplatin and either flurouracil or capecitabine. Recent studies however have shown an improved chance of advanced bowel cancer responding to treatment when bevacizumab is added to standard chemotherapy. Bevacizumab is a new drug which works by blocking one of the main growth factors that controls the development and function of tumour blood vessels. This can reduce tumour blood flow and slow tumour growth as well as impairing the tumour??s ability to spread to other parts of the body. We know, however, that not every patient who receives bevacizumab obtains benefit from it and it can also cause additional side-effects. We need to understand why some patients benefit whilst others do not.In this study, patients will be treated with a combination of chemotherapy and bevacizumab and will undergo a series of blood tests and scans to analyse the effects of bevacizumab on blood vessels within tumour(s). These tests, referred to as biomarkers, may demonstrate changes in the amount of cells and proteins in the blood or changes in the blood flow in tumour(s) detected by the scans. We would like to know whether changes in these Ó?biomarkers? can be used to predict which patients will benefit from bevacizumab.This means that in future only those patients who are likely to derive benefit from bevacizumab receive it and we can spare patients who will not gain benefit, the unnecessary side effects and inconvenience of treatment.We are looking to recruit 70 patients and the study will be conducted at The Christie NHS Foundation Trust, Manchester. The study is an investigator-led trial supported by Roche.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  09/H1008/99

• Date of REC Opinion

  15 Jun 2009

• REC opinion

  Favourable Opinion