ICE CREAM: AG0112CR

• Research type

  Research Study

• Full title

  Randomised Phase II study of cetuximab alone or in combination with irinotecan in patients with metastatic CRC with either KRAS WT or G13D mutation. ICE CREAM: The Irinotecan Cetuximab Evaluation and the Cetuximab Response Evaluation Among Patients with G13D Mutation

• IRAS ID

  116886

• Contact name

  Harpreet Wasan

• Sponsor organisation

  Australasian Gastro-Intestinal Trials Group, Sydney University

• Eudract number

  2012-003638-18

• ISRCTN Number

  ISRCTN

• Research summary

  Although new chemotherapy treatments for metastatic colon cancer have improved outcomes, most patients will still eventually become resistant to treatment and succumb from their disease. Previous studies have demonstrated that cetuximab, an EGFR monoclonal antibody, prolongs survival in patients?? refractory to all other chemotherapy. Some doctors believe combining this treatment with irinotecan will achieve better results however side effects are higher in combination treatment and survival benefit of combination has not been clearly demonstrated. Cetuximab is currently only given as treatment to colorectal cancer patients who have KRAS wild type cancer cells, which means that the cancer cells don't have a mutation in the KRAS gene. KRAS is involved in the transmitting chemical messages inside the cell coming from a protein on the surface of the cell called EGFR.Patients who have a KRAS mutation are not treated with cetuximab although recent research has been presented showing that patients with one particular type of KRAS mutation (G13D) may actually benefit from cetuximab treatment despite their mutation.

• REC name

  London - Central Research Ethics Committee

• REC reference

  12/LO/1857

• Date of REC Opinion

  13 Mar 2013

• REC opinion

  Further Information Favourable Opinion