In this clinical trial, the investigators want to know if cabazitaxel is more effective than methotrexate for patients with recurrent or metastatic squamous cell carcinoma of the head and neck in palliative treatment.
The principal aim is to evaluate the efficacy of cabazitaxel in patients with palliative head and neck previously treated with platinum-based therapy. The study design is a non comparative randomized phase II trial: ARM 1: cabazitaxel (20 mg/m2, every 3 weeks) versus ARM 2 methotrexate (40 mg/m2, weekly). Cabazitaxel dose will be increased to 25mg/m2 for the second and subsequent cycles, in the absence of non-hematological AE \> grade 2 and hematological AE \> grade 3 during the first cycle. (maximum 10 cycles). The aim of the randomization is to offer a valid internal control group by avoiding possible selection bias. However, results obtained in the two treatment group will not be formally compared as this is not the objective of a phase II study. Tumor check-up will be performed every 9 weeks. Treatment will be continued until disease progression or unacceptable toxicities according to the patient or the investigator. A maximum of 10 cycles of cabazitaxel will be given.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
from 20 mg/m2 to 25 mg/m2. Intravenous injection every three weeks.
From 40 mg/m2 (first cycle) to 50 mg/m2. Intravenous injections every three weeks.
Clinique Saint-Pierre
Ottignies, Brabant Wallon, Belgium
Cliniques universitaires Saint-Luc, Centre du Cancer, Oncologie Médicale
Brussels, Brussels Capital, Belgium
Efficacy
Determine the efficacy of cabazitaxel in patients with head and neck cancer in terms of progression-free survival rate at 18 weeks.
Time frame: 18 weeks
Safety profile
Determine the safety profile of cabazitaxel in patients with head and neck cancer: adverse event
Time frame: 18 weeks
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