AXMUS-C

• Research type

  Research Study

• Full title

  The AXitinib MicroBubble UltraSound in metastatic Colorectal cancer trial

• IRAS ID

  73406

• Contact name

  Harpreet Wasan

• Sponsor organisation

  Imperial College Joint Research Office

• Eudract number

  2011-002598-49

• ISRCTN Number

  n/a

• Research summary

  Axitinib is a new biological drug for use in bowel cancer with liver metastases. It works by stopping tumours growing new blood vessels. Without a blood supply tumours stop growing. We are testing the use of Axitinib in patients who have failed all other conventional treatments to assess whether it can halt the progression of their cancer. We can monitor this using contrast enhanced ultrasound, a new bedside ultrasound test that detects changes in blood flow earlier than current scans can show a change in the size of a tumour. We are testing the benefit of Axitinib in 50 patients with colorectal cancer that has spread to the liver and that have failed all other conventional treatments. This is a 2 arm study, ie. on Arm A the patients will receive Axitinib and on Arm B the patients will receive a placebo which is a 'dummy treatment' that will contain no active ingredient but appear identical to Axitinib. Patients will be allocated to an Arm randomly and neither the patient nor doctor treating/scanning the patient will know which Arm patients are on which will make the study 'double-blind.' Patients will be asked to attend outpatient visits with the study doctor in 8 week cycles until disease progression clinically or 1 year post randomisation (whichever is shorter), with clinical examination, blood tests, the latest ultrasound technology and CT scanning. Our aims are:- To establish whether there is benefit in the use of Axitinib in Colorectal Cancer with liver metastsis by improving a progression free survival.-To test the potential for contrast enhanced ultrasound to predict those patients who are likely to respond or not respond to Axitinib-To evaluate whether those that show evidence of tumour blood vessel shutdown have an overall improved survival compared to those not showing a response.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  12/LO/0066

• Date of REC Opinion

  23 Apr 2012

• REC opinion

  Further Information Favourable Opinion