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

  • Robert J. Motzer
  • Robert Amato
  • Mary Todd
  • Wen-J Poo Hwu
  • Roger Cohen
  • Jose Baselga
  • Hyman Muss
  • Michael Cooper
  • Richard Yu
  • Michelle S. Ginsberg
  • Michael Needle
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 carcinomaCetuximabC225monoclonal antibody

Copyright information

© Kluwer Academic Publishers 2003

Authors and Affiliations

  • Robert J. Motzer
    • 1
  • Robert Amato
    • 2
  • Mary Todd
    • 4
  • Wen-J Poo Hwu
    • 5
  • Roger Cohen
    • 7
  • Jose Baselga
    • 9
  • Hyman Muss
    • 10
  • Michael Cooper
    • 11
  • Richard Yu
    • 1
  • Michelle S. Ginsberg
    • 1
  • Michael Needle
    • 13
  1. 1.Memorial Sloan-Kettering Cancer CenterDepartment of Medicine and Department of RadiologyNew YorkUSA
  2. 2.MD Anderson Cancer InstituteHoustonUSA
  3. 3.Baylor College of MedicineHoustonUSA
  4. 4.Cancer Institute of New JerseyNew BrunswickUSA
  5. 5.Yale University School of MedicineNew HavenUSA
  6. 6.Memorial Sloan-Kettering Cancer CenterUSA
  7. 7.University of Virginia Health SciencesCharlottesvilleUSA
  8. 8.Fox Chase Cancer CenterPhiladelphiaUSA
  9. 9.Vall d'Hebron University HospitalBarcelonaUSA
  10. 10.University of Vermont College of MedicineBurlingtonUSA
  11. 11.University of AlabamaBirminghamUSA
  12. 12.Bristol Myers SquibbWallingfordUSA
  13. 13.ImClone Systems IncorporatedSomervilleUSA