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.
National Cancer Institute of Canada
500 participants
Nov 1, 2003
Interventional
Conditions
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
Inclusion Criteria1
- Histologically confirmed colorectal cancer- Metastatic disease- Epidermal growth factor receptor (EGFR)-positive by immunochemistry- Measurable or evaluable disease- Not amenable to standard curative therapy- Best supportive care is the only available option- Must have received a prior thymidylate synthase inhibitor (eg: fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) in the adjuvant or metastatic setting- Combination therapy with oxaliplatin or irinotecan allowed- Must have failed* a prior regimen containing irinotecan and a prior regimen containing oxaliplatin for metastatic disease OR relapsed within 6 months after an adjuvant regimen containing irinotecan or oxaliplatin OR have documented unsuitability for such regimens.
Exclusion Criteria1
- No symptomatic CNS metastases.- Any condition that does not permit compliance with the protocol*NOTE: Failure is defined as either disease progression (clinical or radiological) or intolerance to the regimen.
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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 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)
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ACTRN12606000112561