Phase II trial of antiepidermal growth factor receptor antibody C225 in patients with advanced renal cell carcinoma Journal Article


Authors: Motzer, R. J.; Amato, R.; Todd, M.; Hwu, W. J. P.; Cohen, R.; Baselga, J.; Muss, H.; Cooper, M.; Yu, R.; Ginsberg, M. S.; Needle, M.
Article Title: Phase II trial of antiepidermal growth factor receptor antibody C225 in patients with advanced renal cell carcinoma
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.
Keywords: adult; treatment outcome; aged; aged, 80 and over; middle aged; major clinical study; clinical trial; advanced cancer; dose response; antineoplastic agents; metastasis; phase 2 clinical trial; drug administration schedule; receptor, epidermal growth factor; antineoplastic activity; cetuximab; renal cell carcinoma; kidney carcinoma; kidney neoplasms; monoclonal antibody; rash; antibodies, monoclonal; carcinoma, renal cell; multicenter study; acne; dry skin; infusions, intravenous; epidermal growth factor receptor antibody; humans; human; male; female; priority journal; article; c225
Journal Title: Investigational New Drugs
Volume: 21
Issue: 1
ISSN: 0167-6997
Publisher: Springer  
Date Published: 2003-02-01
Start Page: 99
End Page: 101
Language: English
DOI: 10.1023/a:1022928612511
PUBMED: 12795534
PROVIDER: scopus
DOI/URL:
Notes: Export Date: 12 September 2014 -- Source: Scopus
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  1. Robert Motzer
    1243 Motzer
  2. Michelle S Ginsberg
    235 Ginsberg
  3. Richard J Yu
    4 Yu