Randomised phase II study with cetuximab (Erbitux®) in combination with 5-FU and cisplatin or carboplatin versus CETuximab (Erbitux®) in combination with paclitaxel and carboplatin for treatment of patients with relapsed or METastatic squamous cell carcinoma of the head and neck - CETMET

Radiumhemmet, Karolinska University Hospital, Stockholm, Sweden0 个研究点目标入组 120 人开始时间: 2011年11月18日最近更新: 2020年9月7日

适应症

试验速览

暂无简介。

•>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
•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 when treatment with cisplatin
•Written informed consent must be obtained according to the local Ethics committee.
•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 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•> 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 6 months.
•Patients with clinically relevant neuropathy
•Previously treated for relapsed or metastatic SCCHN
•Previously treated with cetuximab, cisplatin/carboplatin, 5-FU or taxanes for locally advanced SCCHN within 3 months before study entry.
•Patients receiving CYP2C or CYP3A4 inhibitors or inducers

发起方

Radiumhemmet, Karolinska University Hospital, Stockholm, Sweden