This is an open, multicenter phase II study. The purpose is to demonstrate the efficacy of cetuximab in combination with carboplatin and vinorelbine as second line treatment in patients with recurrent or metastatic head and neck cancer who have progressed during or after treatment with first line cisplatinum.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Cetuximab 500 mg/m² i.v. day 1, every 2nd week
Carboplatin AUC = 3 i.v. day 1, every 21nd week
Vinorelbine 25 mg/m² i.v. day 1, every 2nd week
Department of Oncology, Odense University Hospital
Odense, Denmark
Progression-free survival
Time frame: 2.5 years
Response rate
Time frame: 3 years
Toxicity
Time frame: 2.5 years
Median survival
Time frame: 3 years
Correlation between response and evolvement in tumor biology markers.
Time frame: 3 years
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