"Phase II Study of the Combination of Panitumumab With Paclitaxel as First-line Treatment of Subjects With Metastatic or Recurrent Head and Neck Cancer"
- 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
- 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
- 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
- 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 ≤
- 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
- Subjects requiring use of immunosuppressive agents, however, corticosteroids are
- 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.