AGITG - Australasian Gastro Intestinal Trial Group

ICECREAM trial open to recruitment

Irinotecan Cetuximab Evaluation and the Cetuximab Response Evaluation Among Mutants:   A randomised Phase II study of cetuximab alone or in combination with irinotecan in patients with KRAS WT metastatic CRC and patients harbouring a G13D mutation.

After a record short period between trial presentation at the AGITG New Concepts and trial startup, the first patient (harbouring a G13 D mutation) was randomised onto the ICECREAM trial. This trial relies on your support to refer patients with KRAS exon 2 G13D mutations who have progressed on all currently available therapies to a trial centre (listed below).

It is the only trial addressing the issue of anti-EGFR therapy in this group of patients and is the only access for these patients to cetuximab. Three overseas centres have joined the mutant arm of the study: Barcelona (J Tabernero), London (H Wasan) and Naples (F Ciardello).

ICECREAM also tests the benefit of addition of irinotecan to single agent cetuximab, which has not been studied in a pure KRAS WT population. It is the first study to prospectively select WT patients based on the ‘quadruple WT” phenotype (WT in KRAS, BRAF, NRAS and PIK3CA exon 20).

An international trial, patients will be recruited from Australia, London, Spain and Italy.

“This is an important and unique prospective study, which will clarify an ongoing debate about the type of responses that can be achieved the G13D Kras mutants, to specific treatments,” said Dr Harpreet Wasan, Consultant Oncologist, Hammersmith Hospital, London and UK Investigator for the ICE CREAM Study.

“We have no other current treatment options in these patients to epidermal growth factor inhibitors and this study offers the possibility of helping such patients make rational treatment decisions in the future,” he added.

Open for recruitment. Please support this study by referring your patients. Contact the study Principle Investigators A/Prof Eva Segelov or Dr Jeremy Shapiro or your local investigator at any time, with any questions.   For more information about the ICECREAM trial click here.