Liver metastases study investigating 2 chemo regimens + bevacizumab V1

• Research type

  Research Study

• Full title

  A multicentre randomized phase II study to assess the safety and resectability in patients with primarily unresectable liver metastases secondary to colorectal cancer receiving 1st line treatment either with mFOLFOX-6 plus bevacizumab or FOLFOXIRI plus bevacizumab

• IRAS ID

  19458

• Contact name

  Northern & Yorkshire REC

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Eudract number

  2007-007863

• ISRCTN Number

  Not yet available

• Research summary

  This is a multicentre randomized phase II open study to compare the safety and effectiveness of two combination chemotherapy regimens: mFOLFOX-6 (oxaliplatin, leucovorin, 5-FU) plus bevacizumab or FOLFOXIRI (oxaliplatin, leucovorin, 5-FU, irinotecan) plus bevacizumab in subjects with primary liver metastases which are unoperable (unresectable). The liver metastases must be secondary to colerectal cancer. Colorectal cancer is one of the most frequent malignancies. About 40-50% of patients with bowel cancer develop liver metastases during their disease. Bevacizumab (Avastin©) is a novel medication (monoclonal antibody) that may reduce/stop cancer cells from growing. As Bevacizumab and chemotherapy work differently, it is hoped that the combination of the chemotherapy and the monoclonal antibody will be more effective in reducing liver lesions and potentially allow the lesions to be resected with the intention of eradicating the malignancy. The purpose of the study is to determine how effective bevacizumab is when combined with 2 different chemotherapy regimens in causing unresectable liver lesions to become resectable. A further aim is to evaluate the safety of the two combination chemotherapy regimens. Both chemotherapy treatment regimens are approved for use in the UK. F Hoffmann-La Roche Ltd is the study sponsor. This study will involve approximately 20 investigational sites throughout Europe and the UK and include approximately 80 male and female subjects, aged = 18 years, with histological confirmed colon and/or rectum carcinoma with evidence of liver metastases. During the treatment period the subjects will undergo a MRI scan every 6 weeks. Subjects will continue to receive the chemotherapy regimens plus bevacizumab until resectability, progression or unacceptable toxicity. Subjects with resectable lesions will undergo surgery, subjects with progression or unacceptable toxicity will enter a follow up phase. It is expected that subjects will receive active treatment of approximately 12 months depending on how the subjects respond to the treatment.

• REC name

  North East - York Research Ethics Committee

• REC reference

  10/H0903/1

• Date of REC Opinion

  29 Apr 2010

• REC opinion

  Further Information Favourable Opinion