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.
1. Metastatic or recurrent Head and neck cancer
2. Progression after cisplatin, cetuximab and taxanes (drugs could have been
administered alone or in combination) given for recurrent/metastatic disease
3. Age ≥ 18
4. ECOG performance status ≤ 2
5. At least one measurable lesion on CT-scan (as per RECIST criteria V1.1).
6. Life expectancy ≥ 3 months
7. Adequate hematologic function (neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L; Hb
≥ 9.0 g/dL), renal function (clearance creatinine using the CKD-EPI formula (Chronic
Kidney Disease Epidemiology group) ≥ 60 mL/min) and hepatic function (serum
bilirubin ≤ 1 ULN; AST and ALT ≤ 2.5 x ULN).
8. Potentially reproductive patients must agree to use an effective contraceptive method
while on treatment, beginning 2 weeks before the first dose of investigational
product and for 6 months after the final dose of investigational product.
9. Women of childbearing potential must have a negative serum beta-HCG pregnancy test
within 14 days prior of enrolment and/or urine pregnancy test within 48 hours before
the first administration of the study treatment.
10. Patients must be affiliated to a Social Security System.
11. Patient who have received the information sheet and signed the informed consent form.
12. Patients must be willing and able to comply with scheduled visits, treatment plan,
laboratory tests and other study procedures
1. Active concurrent malignancy
2. Progression in the 3 months after the completion of treatment for localized disease
3. Patients with other concurrent severe and/or uncontrolled medical disease which could
compromise participation in the study, such as :
- cardiac disease such as uncontrolled hypertension, congestive cardiac failure,
ventricular arrhythmias, active ischemic heart disease, myocardial infarction
within one year, LVEF > grade 2,
- current active hepatic or biliary disease (with exception of subjects with
Gilbert's syndrome, asymptomatic gallstones, liver metastasis or stable chronic
liver disease per investigator assessment),
- renal disease,
- active GI tract ulceration, malabsorption syndrome, disease significantly
affecting gastrointestinal function, or resection of the stomach or small bowel.
Subjects with active, uncontrolled ulcerative colitis are also excluded,
- severely impaired lung function (spirometry and DLCO 70% or less of normal and
O2 saturation of 88% or less at rest on room air).
4. Patients must have recovered of previous toxicity of chemotherapy and must not have
toxicity grade > 1 ; grade ≥ 2 for neuropathy and grade ≥ 2 for cutaneous rash after
cetuximab (in the CTCAE v4.0)
5. Hypersensitivity to cabazitaxel, to other taxanes, or to any excipients of the
formulation including polysorbate 80
6. Pregnant women, women who are likely to become pregnant or are breast-feeding.
7. Patients with significantly altered mental status prohibiting the understanding of
the study or with psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule;
those conditions should be discussed with the patient before registration in the
8. Patients who received any other investigational drugs within the 14 days prior to the
start of cabazitaxel.
9. Patients receiving radiation within 4 weeks prior to the first dose of study drug.
10. Patients already included in another therapeutic trial involving an experimental drug
11. Individual deprived of liberty or placed under the authority of a tutor.
12. Other primary tumors within the previous 3 years
13. Concomitant prohibited treatment. Concurrent or planned treatment with strong
inhibitors or strong inducers of cytochrome P450 3A4/5. A one week wash-out period is
necessary for patients who are already on these treatments.