Phase II 2-arm trial of the proteasome inhibitor, PS-341 (bortezomib) in combination with irinotecan or PS-341 alone followed by the addition of irinotecan at time of progression in patients with locally recurrent or metastatic squamous cell carcinoma of the head and neck (E1304): A trial of the Eastern Cooperative Oncology Group

Jill Gilbert, Ju Whei Lee, Athanassios Argiris, Missak Haigentz, Lawrence Eric Feldman, Minyoung Jang, Pattatheyil Arun, Carter Van Waes, Arlene A. Forastiere

Research output: Contribution to journalArticle

23 Scopus citations


Background Constitutive activation of nuclear factor κB (NF-κB) is associated with poor prognosis. Irinotecan demonstrates single-agent activity in head and neck cancer but activates NF-κB, promoting cell survival and resistance. Bortezomib is a proteasome inhibitor that inactivates NF-κB. Patients and Methods We performed a randomized phase II trial of bortezomib on days 1, 4, 8, and 11 and irinotecan on days 1 and 8 of each 21-day cycle or single-agent bortezomib on days 1, 4, 8, and 11 on a 21-day cycle. The addition of irinotecan to bortezomib was allowed in patients who progressed on bortezomib alone. Results The response rate of bortezomib and irinotecan was 13%. One patient had a partial response to bortezomib alone (response rate 3%). No responses were seen in patients with addition of irinotecan at time of progression on bortezomib. Conclusions The bortezomib-based regimens evaluated in this study have minimal activity in recurrent or metastatic head and neck cancer. Head Neck, 2013

Original languageEnglish (US)
Pages (from-to)942-948
Number of pages7
JournalHead and Neck
Issue number7
Publication statusPublished - Jul 1 2013



  • bortezomib
  • chemotherapy
  • head and neck cancer
  • irinotecan
  • phase II

ASJC Scopus subject areas

  • Otorhinolaryngology

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