EUCTR2010-022924-57-DKActive, not recruitingPhase 1
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 sites120 target enrollmentStarted: November 18, 2011Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
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 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
Investigators
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