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)
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|ClinicalTrials.gov Identifier: NCT01620242|
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : June 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Head and Neck Cancer Metastatic Head and Neck Cancer||Drug: Cabazitaxel||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||April 2012|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2015|
All patients are treated with Cabazitaxel.
25 mg/m2 every 3 weeks by IV administration
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|