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Cetuximab 5-FU and Cisplatin or Carboplatin Versus Cetuximab With Paclitaxel and Carboplatin Treatment of Metastatic Squamous Cell Carcinoma of Head and Neck

Phase 2
18 Years
75 Years
Open (Enrolling)
Squamous Cell Carcinoma of the Head and Neck

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Trial Information

Cetuximab 5-FU and Cisplatin or Carboplatin Versus Cetuximab With Paclitaxel and Carboplatin Treatment of Metastatic Squamous Cell Carcinoma of Head and Neck

Recurrent and/or metastatic SCCHN patients are, by definition patients with recurrent
disease and/or with newly diagnosed distant metastases, although this group of patients has
a very heterogeneous disease characteristic, they share a dismal prognosis that has changed
little in the past 30 years. The median survival time remains around 6-8 months with a poor
quality of life. Patients with resectable locoregionally recurrent SCCHN may benefit from
surgery. Patients with recurrent SCCHN who are not suitable for curative salvage surgery or
re-irradiation, and patients who have distant metastases, usually receive CT (Cohen EE et
al.) A number of compounds demonstrate single-agent activity in recurrent and/or metastatic
disease including cisplatin, carboplatin, methotrexate, 5-FU, bleomycin and the taxanes (
Scantz SP et al). Cisplatin is one of the most active agents identified for head and neck
cancer, with carboplatin providing an alternative for patients unable to tolerate cisplatin.
While carboplatin is associated with lower response rates than cisplatin, there appears to
be no difference between the agents in terms of survival

Cetuximab is a targeted therapeutic agent, a chimeric IgG1 monoclonal antibody that
specifically binds to the EGFR with high affinity, internalising the receptor and preventing
the ligands EGF and TGF-alfa from interacting with the receptors and thus effectively
blocking ligand-induced EGFR phosphorylation. In addition, cetuximab has been found to
potentiate the effects of chemotherapy and radiotherapy in experimental systems. The dose
of cetuximab has been found to be generally safe and effective in several studies in major
tumor types expressing the EGFR. These included colorectal cancer, squamous cell carcinoma
of the head and neck and non-small cell lung cancer, with cetuximab given either in
combination studies with chemotherapy and radiotherapy or as monotherapy. The main side
effects of cetuximab monotherapy are hypersensitivity- and acne-like skin reactions.

Inclusion 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Description:

To investigate in patients with relapsed or metastatic squamous cell carcinoma of the head and neck whether progression free survival (PFS) in the arm with cetuximab, paclitaxel and carboplatin based chemotherapy is not markedly worse than PFS in the arm with cetuximab and 5-FU, cisplatin or carboplatin based chemotherapy.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Signe Friesland, MD Phd

Investigator Role:

Principal Investigator

Investigator Affiliation:

Karolinska Universityhospital


Denmark: Ethics Committee

Study ID:

CETMET study



Start Date:

November 2011

Completion Date:

November 2015

Related Keywords:

  • Squamous Cell Carcinoma of the Head and Neck
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms