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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival
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.
3 years
No
Signe Friesland, MD Phd
Principal Investigator
Karolinska Universityhospital
Denmark: Ethics Committee
CETMET study
NCT01830556
November 2011
November 2015
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