A Phase II Study In Patients With Advanced Head And Neck Cancer Of Standard Chemoradiation And Add-On Cetuximab

Inclusion criteria:

* T3-4 Nx M0; Tx N2b-3 M0 (N2b only if ≥ 3 ipsilateral nodes involved) and/or total GTV \> 70 cc (any T, any N, M0)
* biopsy proven squamous cell cancer
* primary tumor location in oral cavity, oropharynx, hypopharynx or larynx
* Patients with CUP (cancer of unknown primary) syndrome in case they have advanced lymph node metastases (Tx N2b-3 M0 (N2b only if ≥ 3 ipsilateral nodes involved).- Indication for chemoradiation (RT + Cisplatin)
* curative treatment intent
* Start of chemoradiation within the recruitment time frame
* Performance Status WHO/ECOG: 0-1
* Age between 18 and 75 years
* No previous chemotherapy or RT for cancer of the head and neck
* Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study (until at least 60 days following the last study treatment
* Patient must sign informed consent prior to study entry.

Exclusion criteria:

* Cancer of the nasopharynx
* Any neoadjuvant chemotherapy prior to screening
* Treatment with other investigational drugs within 4 weeks
* History of malignancy other than basal cell skin cancer unless disease free for a minimum of 3 years.
* Uncontrolled claudication, bleeding, or thromboembolic disorders at screening
* Patients receiving heparin, warfarin or phenprocoumon therapy are ineligible- Uncontrolled and severe hypertension at screening according to the judgement of the investigator.
* Current uncontrolled cardiac disease: Unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, history of myocardial infarction within 12 months, significant arrhythmias
* Left ventricular function \< 45 % (determination of left ventricular function required when history of cardiac disease)
* History of stroke within 6 months
* Major surgical procedure, or significant traumatic injury within 28 days prior to screening; anticipation of need for major surgical procedure during the course of the study.
* Acute bacterial or fungal infection requiring intravenous antibiotics at screening
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at screening
* Pregnant (positive pregnancy test) or lactating
* Previous organ transplantation
* Any immune suppressive therapy
* Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition because study treatment might be immuno-suppressive (Note: HIV testing only required if clinically indicated)
* Any uncontrolled condition, which in the opinion of the investigator, would interfere with the safe and timely completion of study procedures.
* Preexisting renal insufficiency with impaired creatinine clearance (\<60ml/min) and/or increased plasma creatinine (\>106 µmol/l) at screening
* History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within 6 months prior to screening
* Serious, non-healing wound, ulcer, or bone fracture
* AST, ALT, or bilirubin \> 1.5 x normal
* Preexisting absolute neutrophil count (ANC) \< 1,800 cells/mm3
* Platelets \< 100,000 103/µl at screening
* PTT \> 1.5 x normal
* WBC \< 4000 103/µl
* Hb \< 11 g/dl at screening (Note: The use of transfusion or other intervention to achieve Hb \> 11 g/dl is possible)
* Contraindication to CDDP
* Known allergy to cetuximab