RecruitingPhase 2ACTRN12623000874617

Biomarcer-2 :Biomarker informed optimal management of advanced RAS wild type colorectal cancer

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


Sponsor

Australasian Gastrointestinal Trials Group

Enrollment

29 participants

Start Date

Oct 8, 2024

Study Type

Interventional

Conditions

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. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with right-sided RAS/BRAF wild type advanced stage colorectal cancer that has not been responsive to an initial treatment regime and you have previously provided a tumour sample for testing. Study details All participants who meet the inclusion criteria will firstly have their previously collected tumour sample tested to determine the level of AREG/EREG cancer cell markers present. Participants who have a high level of AREG and/or EREG cell markers will then begin a treatment regime that combines chemotherapy- irinotecan and biological therapy cetuximab. Treatment will occur every 14 days, in either of two ways- Intravenous infusion on Day 1, or intravenous infusion on Day 1 accompanied by 48 hr infusion pump. The treatment will be at physician discretion. The treatment will continue until disease progression, unacceptable toxicity or withdrawal of participant consent. Participants will be followed up for 3 years after beginning the treatment, unless they choose to withdraw from the study prior to that time. Participants who have a low level of AREG and EREG cell markers will be considered ineligible for participation in this study. It is hoped this research will determine whether the combination of cetuximab and irinotecan based treatment is effective for patients with a high level of AREG/EREG cancer cell markers of advanced stage colorectal cancer. If this treatment is found to be effective for participants with a high level of these markers, this method of screening colorectal patients may then be used more frequently to better prescribe treatments to specific patients.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Colorectal (bowel) cancer that has spread to other parts of the body is challenging to treat, and responses to chemotherapy can vary greatly between patients. This study is investigating whether a combination of chemotherapy (irinotecan) and a targeted biological therapy (cetuximab) works particularly well for patients whose tumours have high levels of specific proteins called AREG and EREG. These proteins may act as a signal that a particular type of cancer is more likely to respond to this treatment combination. If you join the study, a sample of your previously collected tumour tissue will first be tested to check your AREG/EREG levels. If you have high levels, you will receive the irinotecan-cetuximab treatment every 14 days by intravenous infusion, continuing until the cancer progresses or you choose to stop. You will be followed for up to 3 years. People with low AREG/EREG levels are not eligible for treatment in this study. You may be eligible if you are 18 or older with advanced right-sided colorectal cancer that is RAS/BRAF wild type (a specific genetic profile), whose cancer has progressed after prior chemotherapy. You must be fit for the treatment combination and have a tumour sample available for testing. The study is run by the Australasian Gastrointestinal Trials Group.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

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.

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. Dosing regimens include either of the following standard of care regimens for the administration of cetuximab in combination with Irinotecan. They will be chosen at physician discretion; 1) Cetuximab 500mg/m2 Intravenous infusion Day 1 of a 14 day cycle in combination with Irinotecan Intravenous infusion 180mg/m2 Day 1 of a 14 day cycle until disease progression, unacceptable toxicity or withdrawal of consent. 2)Cetuximab 500mg/m2 Intravenous infusion Day 1 of a 14 day cycle in combination with Irinotecan Intravenous infusion 180mg/m2 Day 1 of a 14 day cycle AND Calcium folinate 50mg Intravenous bolus Day 1, Fluorouracil 400mg/m2 Intravenous infusion on Day 1 followed by continuous intravenous infusion Fluorouracil 2400mg/m2 pump over 46 hours until disease progression, unacceptable toxicity or withdrawal of patient consent. Archival tumour tissue from advanced colorectal cancer patients will be tested using an immunohistochemistry assay for Amphiregulin/epiregulin (AREG/EREG)to determine a population of patients who may benefit from this combination of therapy. Participants will be asked to consent to pre- screening of their archival samples for the purpose of AREG/EREG testing. Once consented, testing of archival tissue may take place at any point during the participants first line treatment. There is no time limit for testing results and being considered eligible for the main study. Once AREG/EREG testing results have been received by the site Investigator ,if clinically appropriate the main study participant information and consent form (PICF) will be offered to the participant.


Locations(12)

Western Hospital - Footscray - Footscray

NSW,QLD,TAS,WA,VIC, Australia

Peter MacCallum Cancer Centre - Melbourne

NSW,QLD,TAS,WA,VIC, Australia

South West Healthcare - Warrnambool - Warrnambool

NSW,QLD,TAS,WA,VIC, Australia

Fiona Stanley Hospital - Murdoch

NSW,QLD,TAS,WA,VIC, Australia

Austin Health - Austin Hospital - Heidelberg

NSW,QLD,TAS,WA,VIC, Australia

Latrobe Regional Hospital - Traralgon

NSW,QLD,TAS,WA,VIC, Australia

Calvary Mater Newcastle - Waratah

NSW,QLD,TAS,WA,VIC, Australia

Newcastle Private Hospital - New Lambton Heights

NSW,QLD,TAS,WA,VIC, Australia

The Northern Hospital - Epping

NSW,QLD,TAS,WA,VIC, Australia

Cabrini Hospital - Malvern - Malvern

NSW,QLD,TAS,WA,VIC, Australia

The Canberra Hospital - Garran

NSW,QLD,TAS,WA,VIC, Australia

North West Cancer Centre - Tamworth Hospital - Tamworth

NSW,QLD,TAS,WA,VIC, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12623000874617