Investigational New Drugs

, Volume 30, Issue 3, pp 1138–1143

Phase II study of nimotuzumab, a humanized monoclonal anti-epidermal growth factor receptor (EGFR) antibody, in patients with locally advanced or metastatic pancreatic cancer

  • Dirk Strumberg
  • Beate Schultheis
  • M. E. Scheulen
  • R. A. Hilger
  • J. Krauss
  • N. Marschner
  • F. Lordick
  • F. Bach
  • D. Reuter
  • L. Edler
  • K. Mross
PHASE II STUDIES

DOI: 10.1007/s10637-010-9619-8

Cite this article as:
Strumberg, D., Schultheis, B., Scheulen, M.E. et al. Invest New Drugs (2012) 30: 1138. doi:10.1007/s10637-010-9619-8

Summary

Introduction Nimotuzumab is a humanized monoclonal antibody that binds to the EGFR. Based on phase I data, the recommended dose has been established at 200 mg weekly. This study was aimed at evaluating the safety and efficacy of nimotuzumab monotherapy in patients (pts) with locally advanced or metastatic pancreatic cancer. Methods Pts who failed first line standard chemotherapy for advanced disease and had at least one measurable lesion were eligible for the study. Nimotuzumab was given intravenously at 200 mg once weekly for 6 weeks (wks). Follow up by CT scan was performed after 8 weeks. Pts continued receiving treatment 3-weekly until disease progression or unacceptable toxicity occurred. Endpoints included tumor response (RECIST), progression-free survival (PFS), and safety. Results A total of 56 pts were enrolled for treatment (ECOG status of 1 [n = 41] or 0 [n = 15]), the majority (47 pts) had metastatic disease. Nearly half of the pts [n = 26] received ≥2 regimens. Pts evaluable for response: n = 36; CR: 0; PR: 0; SD: 6 pts. Median PFS for pts with SD was 19.2 weeks, for all pts 6.7 weeks (95% CI: 6.43–7.14 weeks). PFS after 1 year was 10.3% with a median overall survival of 18.1 weeks. Treatment-related adverse events were generally mild including rash grade 1 in 5 pts. After a single dose of 200 mg, the t1/2 was calculated to 45 h. Conclusion These data confirm that nimotuzumab is safe and very well tolerated. To improve efficacy, a randomized, placebo-controlled trial with Gem has been initiated.

Keywords

Pancreatic cancerNimotuzumabEGFR antibodyClinical trialAdvanced disease

Copyright information

© Springer Science+Business Media, LLC 2010

Authors and Affiliations

  • Dirk Strumberg
    • 1
  • Beate Schultheis
    • 1
  • M. E. Scheulen
    • 2
  • R. A. Hilger
    • 2
  • J. Krauss
    • 2
    • 3
  • N. Marschner
    • 4
  • F. Lordick
    • 5
    • 6
  • F. Bach
    • 7
  • D. Reuter
    • 7
  • L. Edler
    • 8
  • K. Mross
    • 9
  1. 1.Department of Hematology and Medical OncologyUniversity of Bochum, Marienhospital HerneHerneGermany
  2. 2.Department of Medical OncologyUniversity Hospital of EssenEssenGermany
  3. 3.National Center for Tumor Diseases (NCT)University of HeidelbergHeidelbergGermany
  4. 4.Onkologische Schwerpunktpraxis FreiburgFreiburgGermany
  5. 5.Department of Hematology and Medical OncologyUniversity Hospital of Munich “Klinikum Rechts der Isar”MunichGermany
  6. 6.Medizinische Klinik III, Innere Medizin, Hämatologie und OnkologieKlinikum BraunschweigBraunschweigGermany
  7. 7.OncoscienceAGWedelGermany
  8. 8.German Cancer Research CenterHeidelbergGermany
  9. 9.Tumor Biology Center at the UniversityFreiburgGermany