Phase II study of rubitecan in recurrent or metastatic head and neck cancer

Francesco Caponigro, Giacomo Cartenì, Jean Pierre Droz, Amalia Milano, Wayne B. Davis, Patricia Pollard

Research output: Contribution to journalArticlepeer-review


Purpose: Rubitecan is an oral camptothecin analogue that has shown activity against a broad spectrum of human tumor xenografts and has been tested in several diseases. Patients and methods: In the present study, 19 patients with incurable, recurrent or metastatic head and neck cancer were treated with rubitecan at the initial dose of 1.5 mg/m2 × 5 days per week. An appropriate dose modification program was set up according to the observed toxicities. Results: Thirteen out of the 19 treated patients were formally evaluable for tumor response. Ten patients had a disease progression and three patients had a stabilization of disease as their best response. The mean duration of stable disease was 141 days. Median survival was 16 weeks (range 2-22 weeks). Three patients died during the study or less than a month after their last dose of study medication. Hematologic toxicity was serious in this study since four patients discontinued their participation because of severe anemia. The drug was also associated with grade 1-4 neutropenia, and with 1-3 thrombocytopenia. Conclusion: We conclude that rubitecan is not effective as a single-agent in recurrent or metastatic head and neck cancer with the doses and schedule used in this study.

Original languageEnglish
Pages (from-to)209-214
Number of pages6
JournalCancer Chemotherapy and Pharmacology
Issue number2
Publication statusPublished - Jul 2008


  • Head and neck cancer
  • Oral camptothecin
  • Phase II study
  • Rubitecan

ASJC Scopus subject areas

  • Cancer Research
  • Pharmacology
  • Oncology


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