Abstract
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.
Publication types
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Clinical Trial
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Clinical Trial, Phase II
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Multicenter Study
MeSH terms
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Adult
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Aged
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Aged, 80 and over
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Antibodies, Monoclonal / administration & dosage
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Antibodies, Monoclonal / pharmacology
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Antibodies, Monoclonal / therapeutic use*
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Antibodies, Monoclonal, Humanized
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Antineoplastic Agents / administration & dosage
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Antineoplastic Agents / pharmacology
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Antineoplastic Agents / therapeutic use*
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Carcinoma, Renal Cell / drug therapy*
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Carcinoma, Renal Cell / secondary
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Cetuximab
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Drug Administration Schedule
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ErbB Receptors / antagonists & inhibitors*
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ErbB Receptors / immunology
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Female
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Humans
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Infusions, Intravenous
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Kidney Neoplasms / drug therapy*
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Kidney Neoplasms / pathology
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Male
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Middle Aged
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Treatment Outcome
Substances
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Antibodies, Monoclonal
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Antibodies, Monoclonal, Humanized
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Antineoplastic Agents
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ErbB Receptors
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Cetuximab