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
|Study Design:||Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
- Toxicity according to NCI-CTCAE v4.0 [ Time Frame: from the first dose up to 30 days after the last dose ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||April 2015|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
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|