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

This is an interventional treatment trial for Oropharyngeal Cancer Read More

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