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Clinical Trials/ACTRN12623000874617
ACTRN12623000874617
Not yet recruiting
Phase 2

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

Australasian Gastrointestinal Trials Group0 sites29 target enrollmentAugust 15, 2023
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ConditionsAdvanced RAS Wild type right sided Colorectal cancerCancer - Bowel - Back passage (rectum) or large bowel (colon)

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Advanced RAS Wild type right sided Colorectal cancer
Sponsor
Australasian Gastrointestinal Trials Group
Enrollment
29
Status
Not yet recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 15, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Australasian Gastrointestinal Trials Group

Eligibility Criteria

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 (less than 50% tumour cell positivity for either ligand) 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

Exclusion Criteria

  • •1\. Previous exposure to an EGFR inhibitor
  • •2\. Grade 2 or greater diarrhoea at time of enrolment
  • •3\. Any contraindication to combination treatment with cetuximab \+ irinotecan based treatment
  • •4\. History of another primary cancer within the last 3 years that was either not treated with curative intent or has persisted or relapsed.
  • •5\. Patients with multiple primary colorectal cancers
  • •6\. Inadequate paraffin tumour sample available for AREG/EREG expression confirmation.
  • •7\. Tumours with low AREG/EREG expression levels ( less than 50% tumour cell positivity for either ligand) as determined by central laboratory testing of archival tumour tissue.
  • •8\. Inadequate organ function:
  • •a. Moderate/severe renal impairment (GFR less than 45 ml/min), as calculated by the Cockcroft\-Gault equation
  • •b. Absolute neutrophil count less than 1\.0x109/L

Outcomes

Primary Outcomes

Not specified

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