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Brief Title: A Phase II, Open-Label, Multicenter Trial of Cabazitaxel in Patients With Recurrent or Metastatic Head and Neck Cancer After Failure Of Cisplatin, Cetuximab and Taxanes
Official Title: A PHASE II, OPEN-LABEL, MULTICENTER TRIAL OF CABAZITAXEL IN PATIENTS WITH RECURRENT OR METASTATIC HEAD AND NECK CANCER AFTER FAILURE OF CISPLATIN, CETUXIMAB AND TAXANES.
Study ID: NCT01620242
Brief Summary: This is a multi-center phase II study assessing whether cabazitaxel could be efficient for treatment of recurrent or metastatic head and neck cancer after failure of cisplatin, cetuximab and taxanes.
Detailed Description: Patients will be treated with intravenous cabazitaxel 25 mg/m2 every 3 weeks (D1=D22) for 6 cycles. In absence of progression disease or unacceptable toxicity, the treatment could be continued until a maximum of 10 cycles. Disease response will be assessed every 6 weeks (i.e. every 2 cycles) clinically and by CT-scan. An interim analysis will be carried out after the inclusion of the first 10 eligible and assessable patients.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Centre Oscar Lambret, Lille, , France
Centre Léon Berard, Lyon, , France
Centre Antoine Lacassagne, Nice, , France
Institut Curie, Paris, , France
Institut Gustave Roussy, Villejuif, , France