locally advanced inoperable head and neck squamous cell carcinoma MedDRA version: 9.1 Level: HLT Classification code 10026660
Conditions
Interventions
Trade Name: ERBITUX*INFUS 1FL 100ML 5MG/ML
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cetuximab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concent
Sponsors
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE "G. PASCALE"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Hystologically or cytologically confirmed HNC with exclusion of the nasopharynx 2.Locally advanced inoperable disease 3.age > 18 years 4.ECOG PS: 0-1 5.Life expectancy at least 3 months at study entrance 6.Normal bone marrow reserve (absolute neuthrophil count > 1500/mm3; platelets > 100000/mm3; haemoglobin > 9 g/dl) 7.Normal hepatic function (total serum bilirubin 3 x upper limit of normal) 8.Normal renal function (serum creatinine 60 ml/min). 9.Normal cardiac function (assessed by ECG and ecocardiography with ejection fraction > 50%) 10.No pregnancy 11.No prior chemo or radiotherapy 12.Written informed consent. 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: 1.Concomitant treatment with investigation agents 2.Nasopharygeal carcinoma 3.Brain metastases (CT scan or MRI required only in case of clinical suspicion of CNS metastases) 4.Second malignancies 5.History of myocardial infarction within the last 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - to evaluate the maximum tolerated dose of capecitabine to be used in combination with standard docetaxel and cisplatin. - To evaluate the safety and tolerability of the combination of capecitabine, docetaxel and cisplatin in locally advanced head and neck cancers. - to assess progression free survival in patients with locally advanced head and neck cancer who will be treated according to the protocol - to confirm the safety tolerability of the combination, to evaluate overall survival time, response rate, disease control rate, duration of response and time to progression.;Secondary Objective: - to evaluate overall survival time, best overall response, disease control, duration of response and time to treatment failure;Primary end point(s): Objective response and toxicity | — |
Countries
Italy
Outcome results
None listed