Randomised Phase II, Cetuximab in Combination With 5FU and Cisplatin or Carboplatin Versus Cetuximab in Combination With Paclitaxel and Carboplatin for Treatment of Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck (CETMET)
Squamous Cell Carcinoma of the Head and Neck
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma of the Head and Neck
Eligibility Criteria
Inclusion criteria
- >18 years
- Histologically or cytologically confirmed SCCHN, relapsed and/or metastatic
- Patient must have a life expectancy of at least 3 months allowing adequate follow-up toxicity evaluation.
- Clinical examination
- 1 unidimensional lesion according to RECIST 1.1.
- PS WHO 0-1 at study entry
- Adequate hematological function defined as WBC ≥3 x 109/litre and platelets ≥100 x 109/litre, ANC > 1.5 x 109/litre and Hb > 100 g/L
- Adequate liver function; bilirubin < 1.5 x UNL, ALAT or ASAT<3.0 UNL, alkaline phosphates < 2.5 UNL.
- Creatinine clearance > 50mL/min
- Written informed consent must be obtained according to the local Ethics committee.
Exclusion Criteria:
- > 75 years
- Nasopharyngeal cancer and cancer of the paranasal sinuses
- Inability to follow the treatment and evaluation schedule
- Any other condition or therapy which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives
- Pregnant or nursing females or male or female of child-bearing potential not using adequate methods of birth-control
- Patients with active infections or any other serious underlying medical condition, which would impair the ability of the patients to receive the protocol treatment
- Known hypersensitivity to any of the components of the treatment
- Legal incapacity
- Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
- Patients with clinically relevant neuropathy
- Previously treated for relapsed or metastatic SCCHN except radiotherapy for previously treated relapse if terminated > 3 months before start of treatment.
- Previously treated with cetuximab, cisplatin/carboplatin, 5-FU or taxanes for locally advanced SCCHN within 3 months before study entry.
Sites / Locations
- Lena SpechtRecruiting
- Hedda HaugenRecruiting
- Karolinska UniversityhospitalRecruiting
- Karin SöderströmRecruiting
- Akademiska Universityhospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm A: cetuximab with 5FU and carboplatin or cisplatin
Arm B: cetuximab paclitaxel and carboplatin
Arm A:Day 1 Cetuximab 400 mg/m2 iv 120 minutes Day 8 and 15 Cetuximab 250 mg/m2 iv 60 minutes Day 1 Cisplatin 100mg/m2 or Carboplatin AUC 5 day 1-4 5-Fluorouracil 1000 mg/m2 iv 24 h maintenance treatment thereafter with cetuximab 500 mg/m2 every second week until PD or toxicity
Arm B day 1 Cetuximab 400 mg/m2 iv 120 minutes Day 8 and 15 Cetuximab 250 mg/m2 iv 60 minutes day 1 Paclitaxel 175 mg/m2 day 1 Carboplatin AUC 5 treatment for 6 cycles thereafter maintenance treatment day 1 Cetuximab 500 mg/m2 every second week treatment until progress or unacceptable toxicity