Randomized Phase II Study of Cabazitaxel Versus Methotrexate in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With Platinum-based Therapy.
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the efficacy of cabazitaxel in patients with head and neck cancer in terms of progression-free survival rate at 18 weeks.
Jean-Pascal Machiels, MD, PhD
Centre du Cancer, Cliniques universitaires Saint-Luc
Luxembourg: Comite National d'Ethique de Recherche