•
Cetuximab WEEKLY until progression
or unacceptable toxicity
Control arm (EXTREME)
(6 cycles every 3 weeks )
Cisplatine: 100 mg/m2 iv
5FU: 4000 mg/m2
during 96h in continuous infusion
Cetuximab:
400 mg/m2 iv (loading dose), then 250 mg/m2 iv
•
Cetuximab BIWEEKLY until progression or
unacceptable toxicity
Experimental arm (TPEx)
(
4 cycles
every 3 weeks )
Cisplatine:
75 mg/m2 iv
Docetaxel:
75 mg/m2 iv
Cetuximab:
400 mg/m2 iv (loading dose), then 250 mg/m2
iv
G-CSF
Phase II
(R 1:1)
(N = 540)
R
Randomisation on: age, sex, PS, tumour location, type of evolution, HPV status
TPEXTREME
