patients with advanced squamaous cell carcinom on oropharynx or oral cavity MedDRA version: 12.1 Level: LLT Classification code 10041857 Term: Squamous cell carcinoma of the oral cavity MedDRA version: 12.1 Level: LLT Classification code 10031112 Term: Oropharyngeal squamous cell carcinoma
Conditions
Interventions
Trade Name: Erbitux
Product Name: Cetuximab
Product Code: L01XC06
Pharmaceutical Form: Solution for infusion
Trade Name: Taxotere
Product Name: Taxotere
Product Code: L01CD02
Pharmaceutical Form: Con
Sponsors
Charité Universitätsmedizin Berlin - CVK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - histologically confirmed relapse or metastasis of an advanced squamaous cell carcinoma in oropharynx or oral cavity - patients with relapse and/or metastasis of the head and neck for whom a local therapy is not indicated - patients with at least one measurable lesion according RECIST-criteria version 1.0 - ECOG performace status 0 or 1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - radiotherapy within the last 6 months before screening - systemic chemotherapy apart from radiochemotherapy for local advanced tumor - therapy with antibodies or protein kinase inhibitors - any prior or existing malignancies except SCCHN. Except for basal squamous scell skin cancer and adequately treated carcinoma in situ of the cervix
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: time to progression;Secondary Objective: - tumor response - progression free survival (PFS) - median survival time - quality of life - toxicity;Primary end point(s): time to progression | — |
Countries
Germany
Outcome results
None listed