A phase II dose finding study of induction cisplatin, docetaxel and escalating doses of capecitabine followed by concurrent cetuximab and radiotherapy in locally advanced inoperable head and neck squamous cell carcinoma - DOXERT 1

• Conditions: locally advanced inoperable head and neck squamous cell carcinoma; MedDRA version: 9.1Level: HLTClassification code 10026660

• Registration Number: EUCTR2010-018363-42-IT
• Lead Sponsor: ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-27
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 < 1.5 x upper limit of normal; liver transaminases > 3 x upper limit of normal) 8.Normal renal function (serum creatinine < 1,25 x upper limit of normal and creatinine clearance > 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified