Study of the Combination of Panitumumab With Paclitaxel as First-line Treatment of Subjects With Head and Neck Cancer

Inclusion Criteria:

* Signed Inform Consent
* Age \> 18 years
* Histologically or cytologically confirmed SCCHN
* Diagnosis of metastatic disease by the investigator and/or recurrent disease determined to be incurable by surgery or radiotherapy
* Subjects who have received radiation as primary therapy are eligible if radiation therapy treatment was completed \> 4 weeks prior to inclusion
* Subjects who have previously received chemotherapy as part of the initial multimodality treatment for locally advanced disease are eligible if the chemotherapy was completed \> 24 weeks prior to inclusion
* At least 1 unidimensionally measurable lesion of ≥ 20 mm using conventional techniques or ≥10 mm with spiral CT scan. Target lesions must not be chosen from a previously irradiated field unless there had been documented tumour progression in that lesion prior to inclusion
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 at screening
* Haematological function:

  * ANC ≥ 1.5 x 109 cells/L
  * Hemoglobin ≥ 9.0 g/dL
  * Platelet count ≥ 100 x 109/L
* Kidney function:

  o Adequate renal function with creatinine clearance ≥ 60 mL/min)
* Liver function:

  * AST ≤ 3 x ULN (if liver metastases, ≤ 5 x ULN)
  * ALT ≤ 3 x ULN (if liver metastases, ≤ 5 x ULN)
  * Bilirubin ≤ 2 x ULN
* Metabolic function:

  * Magnesium ≥ lower limit of normal,
  * Calcium ≥ lower limit of normal

Exclusion Criteria:

* Documented or symptomatic central nervous system metastases
* Nasopharyngeal carcinoma
* History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest scan
* History of another primary cancer, except:

  * Curatively treated in situ cervical cancer, or
  * Curatively resected non-melanoma skin cancer or
  * Other primary solid tumour curatively treated with no known active disease present and no treatment administered for ≥ 3 years prior to starting the study treatment. In that case confirmation of inclusion by the sponsor is required.
* Clinically significant cardiovascular disease ≤ 1 year prior to starting the study treatment
* Pulmonary embolism, deep vein thrombosis, or other significant thromboembolic event ≤ 8 weeks prior to starting the study treatment
* Symptomatic peripheral neuropathy of Grade ≥ 2 based on the CTCAE v3.0
* Subjects not recovered from all previous acute radiotherapy-related toxicities to ≤ grade 1
* History of severe skin disorder that in the opinion of the investigator may interfere with study conduct
* Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic hepatitis B infection
* Active infection requiring systemic treatment or any uncontrolled infection ≤ 14 days prior to starting the study treatment
* History of interstitial pneumonia or pulmonary fibrosis or signs of interstitial pneumonia or pulmonary fibrosis on the baseline chest X-ray.
* Known allergy or hypersensitivity to panitumumab, or other study medications.
* Prior anti epidermal growth factor receptor (EGFr) antibody therapy or treatment with small molecule EGFr inhibitors unless received as part of prior multimodality treatment and completed \> 24 weeks prior to starting the study treatment. In this case, the investigator should confirm that the subject had not presented any previous cetuximab-related infusion reaction \> grade 2.
* Subject is currently enrolled in or ≤ 30 days since ending other investigational device, investigational procedure, or drug study(s), or subject is receiving other investigational agent(s)
* Subjects requiring use of immunosuppressive agents, however, corticosteroids are allowed
* Man or woman of child-bearing potential who do not consent to use adequate contraceptive precautions during the course of the study, and for 6 months after the last study drug administration for women, and 3 months for men.
* Female subject who is pregnant or breast-feeding, or planning to become pregnant within 6 months after the end of treatment.
* Major surgery requiring general anesthesia/ spinal anesthesia and a significant incision ≤ 28 days or minor surgery ≤ 14 days prior to starting the study treatment. Subjects must have recovered from surgery-related toxicities.
* Subjects who do not wish to meet the study requirements or are unable to do so.