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 |