Squamous Cell Carcinoma of the Head and Neck Clinical Trial
Official title:
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.
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.
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