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 (ORL03)
|Recurrent Head and Neck Cancer Metastatic Head and Neck Cancer||Drug: Cabazitaxel||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- non-progression at 6 weeks [ Time Frame: 6 weeks ]
To assess the efficacy of cabazitaxel in terms of non-progression at 6 weeks for the treatment of recurrent or metastatic head and neck cancer after failure of cisplatin, cetuximab and taxanes.
Non-progression will be assessed after centralized review of CT-scans.
- progression free survival [ Time Frame: 1-year ]
- Toxicity according to NCI-CTCAE v4.0 [ Time Frame: from the first dose up to 30 days after the last dose ]
- Quality of life evaluated by the QLQ-C30 and H&N35 questionnaire [ Time Frame: at the inclusion, at 6 weeks and at the end of treatment ]
|Study Start Date:||April 2012|
|Study Completion Date:||April 2015|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
All patients are treated with Cabazitaxel.
25 mg/m2 every 3 weeks by IV administration
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01620242
|Centre Oscar Lambret|
|Lille, France, 59020|
|Centre Léon Berard|
|Lyon, France, 69008|
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Paris, France, 75231|
|Institut Gustave Roussy|
|Villejuif, France, 94805|