CompletedPhase 3ACTRN12606000112561

Cetuximab and Best Supportive Care Compared with Best Supportive Care Alone in Treating Patients with Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer.

Phase III Randomised Study of Cetuximab and Best Supportive Care Versus Best Supportive Care Alone in survival of Patients With Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer.

Sponsor

National Cancer Institute of Canada

Enrollment

500 participants

Start Date

Nov 1, 2003

Study Type

Interventional

Conditions

Colorectal Cancer - stage IV colon cancer - recurrent colon cancer - recurrent rectal cancer - stage IV rectal cancer

Summary

Therapeutic options for patients with metastatic colorectal cancer whose cancers have progressed after treatment with standard therapies are limited. Cetuximab therapy is a new treatment targeting the epidermal growth factor receptor (EGFR, a protein on the surface of many cancer cells). Cetuximab can attach to this protein and may stop cancer growth. This study will examine the effect of cetuximab on length and quality of life in people with advanced EGFR positive colorectal cancer whose cancer has progressed after chemotherapy.

Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying: Cetuximab and Best Supportive Care Compared with Best Supportive Care Alone in Treating Patients with Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer. It may be open to adults aged 16 and older who meet certain criteria, including: Histologically confirmed colorectal cancer. Participation typically involves medical assessments, possible treatment with the study intervention, and follow-up visits to track your health.

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

This is a randomised, open-label, multicenter study. Patients are stratified according to participating center and ECOG performance status (0 or 1 vs 2). Patients are randomised to 1 of 2 treatment

This is a randomised, open-label, multicenter study. Patients are stratified according to participating center and ECOG performance status (0 or 1 vs 2). Patients are randomised to 1 of 2 treatment arms. Arm I: Patients receive an initial loading dose of cetuximab (Erbitux) IV over 120 minutes on day 1. Patients continue to receive maintenance infusions of cetuximab IV over 60 minutes weekly. Patients also receive best supportive care, defined as measures designed to provide palliation of symptoms and improve quality of life as much as possible. Arm II: Patients receive best supportive care as in arm I. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, and then at 4, 8, 16, and 24 weeks (or until deterioration to ECOG PS 4 or hospitalisation for end of life care). Patients are followed up every 4 weeks.

Locations(1)

Australia

View Full Details on ANZCTR

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

Visit

ACTRN12606000112561