Phase I trial of zalutumumab and irinotecan in metastatic colorectal cancer patients who have failed irinotecan- and cetuximab-based therapy

Mano, Max S.;Hendlisz, Alain;Machiels, Jean-Pascal;Ehrnrooth, E.;Van Laethem, Jean-Luc;et.al.
(2009) 45th Annual Meeting of the American-Society-of-Clinical-Oncology — Location: (United-States) Orlando, Florida (29.May.2009)

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Authors
  • Mano, Max S.
    Author
  • Hendlisz, Alain
    Author
  • Machiels, Jean-PascalUCLouvain
    Author
  • Ehrnrooth, E.
    Author
  • Van Laethem, Jean-Luc
    Author
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Abstract
[Background:] Zalutumumab is a novel human IgG1 anti-EGFR mAb. We investigated the safety of zalutumumab and irinotecan in heavily pretreated mCRC patients. [Methods:] Metastatic CRC patients with documented progression (PD) during or within 6 months of stopping cetuximab and irinotecan based therapy were eligible. No prior treatment with anti-EGFR antibodies other than cetuximab was allowed. Patients received weekly doses of zalutumumab 8mg/kg and 16 mg/kg respectively in combination with irinotecan (180 mg/m2) every second week until PD or unacceptable toxicity. [Results:] The maximum tolerated dose was not reached and no patients experienced any dose limiting toxicity. At data cut-off (18-Dec-08) 4 patients had died (no cases of death were considered related to zalutumumab), 4 were off study due to PD and 1 was still ongoing (Table 1). In total, 6 patients experienced one or more grade 3/4 toxicities (diarrhea 2; neutropenia 2; leucopenia 1; abdominal pain 1; pulmonary embolism 1; alopecia 1). [Conclusions:] Zalutumumab can be safely administrated in doses up to 16mg/kg in combination with irinotecan in mCRC patients failing cetuximab and irinotecan based therapy. Zalutumumab and irinotecan resulted in durable stable disease warranting further investigation of this regimen.
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Mano, M. S., Hendlisz, A., Machiels, J.-P., Ehrnrooth, E., Aladdin, H., & Van Laethem, J.-L. (2009). Phase I trial of zalutumumab and irinotecan in metastatic colorectal cancer patients who have failed irinotecan- and cetuximab-based therapy. Journal of Clinical Oncology, 27(15), e15028. https://hdl.handle.net/2078.5/147016 (Original work published 2009)