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Phase II single arm study to explore the efficacy of cetuximab (in combination with irinotecan based treatment) in advanced stage RAS/BRAF wild-type right-sided colorectal cancer with high AREG/EREG expression

ACTRN 12623000874617

Brief Summary

This study aims to determine whether patients with a high level of Amphiregulin/epiregulin (AREG/EREG) cancer cell markers for advanced stage colorectal cancer have a better treatment response to a combined chemo- and biological regime.

Intervention/Treatment

  • Drug: Cetuximab.
  • Drug: Irinotecan.
  • Drug: Fluorouracil.

Inclusion Criteria

  1. Patients aged greater than 18 years of age.
  2. ECOG performance status 0-1.
  3. Patients with advanced colorectal cancer.
  4. Primary tumour arising from right side of colon (proximal to the splenic flexure).
  5. RAS/BRAF wild type.
  6. Tumours with high AREG/EREG expression as determined by central laboratory testing.
  7. At least one measurable lesion as per RECIST 1.1 criteria.
  8. Receipt of fluoropyrimidine and oxaliplatin containing therapy (FOLFOX,CAPOX or FOLFOXIRI) +/- bevacizumab as part of the initial treatment of advanced disease, or progression within 6 months of completing oxaliplatin based adjuvant therapy for early stage disease.
  9. Fit for treatment with cetuximab and irinotecan based treatment.
  10. Life expectancy greater than 3 months.

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