Investigational New Drugs

, Volume 21, Issue 1, pp 99–101

Phase II Trial of Antiepidermal Growth Factor Receptor Antibody C225 in Patients with Advanced Renal Cell Carcinoma

Authors

  • Robert J. Motzer
    • Memorial Sloan-Kettering Cancer CenterDepartment of Medicine and Department of Radiology
  • Robert Amato
    • MD Anderson Cancer Institute
  • Mary Todd
    • Cancer Institute of New Jersey
  • Wen-J Poo Hwu
    • Yale University School of Medicine
  • Roger Cohen
    • University of Virginia Health Sciences
  • Jose Baselga
    • Vall d'Hebron University Hospital
  • Hyman Muss
    • University of Vermont College of Medicine
  • Michael Cooper
    • University of Alabama
  • Richard Yu
    • Memorial Sloan-Kettering Cancer CenterDepartment of Medicine and Department of Radiology
  • Michelle S. Ginsberg
    • Memorial Sloan-Kettering Cancer CenterDepartment of Medicine and Department of Radiology
  • Michael Needle
    • ImClone Systems Incorporated
Article

DOI: 10.1023/A:1022928612511

Cite this article as:
Motzer, R.J., Amato, R., Todd, M. et al. Invest New Drugs (2003) 21: 99. doi:10.1023/A:1022928612511

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.

renal cell carcinoma Cetuximab C225 monoclonal antibody

Copyright information

© Kluwer Academic Publishers 2003