An Open, Single Dose Escalation Study Followed by a Multiple Dose Extension of Anti-EGF Receptor Human Monoclonal Antibody (Zalutumumab) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
The study population eligible for this study is adult male or female patients of good
performance status having a histologically confirmed recurrent or metastatic SCCHN, not
amenable to standard curative or palliative therapies.
- Diagnosis of squamous cell carcinoma of the oral cavity, nasal cavity, paranasal
sinuses, nasopharynx, oropharynx, hypopharynx or larynx.
- Primary or recurrent disease for which no curative or established palliative
treatments are amenable
- WHO performance status of 1 or 2.
- Received certain other treatments within 4 weeks prior to administration of study
- Previous severe allergic reactions (e.g. angio-edema, severe asthma, or anaphylaxis).
- Skin disease requiring systemic or local corticosteroid therapy.
- Known brain metastasis or leptomeningeal disease.
- Signs or symptoms of acute illness.
- Bacterial, fungal or viral infection.
- Certain serious medical conditions, including kidney or liver disease, some
psychiatric illnesses, myocardial infarction within one year and stomach, lung,
heart, hormonal, nerve or blood diseases.
- Pregnant or breast-feeding women.
- Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth
control during the whole trial.
- Simultaneous participation in any other trial involving investigational drugs or
having participated in a trial within 4 weeks prior to start of trial treatment.