Phase II Trial of Antiepidermal Growth Factor Receptor Antibody C225 in Patients with Advanced Renal Cell Carcinoma
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- Motzer, R.J., Amato, R., Todd, M. et al. Invest New Drugs (2003) 21: 99. doi:10.1023/A:1022928612511
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Fifty-five patients with metastatic renal cell carcinoma (RCC) were treated on a multicenter, single-arm Phase II trial. Patients received single-agent Cetuximab (C225) administered by intravenous infusion at a loading dose of 400 or 500 mg/m2 followed by weekly maintenance doses at 250 mg/m2. None of the patients treated with C225 achieved either a complete or partial response. The median time to progression was 57 days. The most frequently reported grade 3 or 4 toxicity treatment-related adverse events were acne (17%) and rash or dry skin (4%). The lack of clinical response or suggestion of prolonging time to progression compared to historical data with interferon-alfa supports no further study of single-agent C225 in patients with metastatic RCC.