Study of Proxinium Plus Best Supportive Care Versus Best Supportive Care for Patients With Advanced Head and Neck Cancer

Inclusion Criteria: Disease Characteristics * The patient must be 18 years of age or older. * The patient must have squamous cell carcinoma of the head and neck. * The squamous cell carcinoma must be Ep-CAM positive. * ECOG performance status of 0, 1, 2 or 3. * 12 week life expectancy Prior/Concurrent Therapy * The patient must have received therapy for their primary disease (eg, surgery and/or radiotherapy, chemo-radiotherapy or chemotherapy). * The patient must have been diagnosed with persistent or recurrent disease or a second primary tumour. * The patient's disease must be refractory. * There must be at least 2 weeks between the last dose of chemotherapy or radiotherapy and receiving study drug or 4 weeks between the last dose of an experimental drug and receiving study drug. Patient Characteristics * The patient must have adequate hepatic function \[alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN) and bilirubin level ≤1.5 × ULN\]. * The patient must have adequate renal function (serum creatinine \< 1.5 × ULN). * The patient must have the following hematological values: granulocytes ≥1500/μL, platelets ≥75 000/μL and hemoglobin \>8 g/dL. * The patient must have prothrombin time and partial thromboplastin time within normal limits. Other • Women of childbearing potential and male patients must agree to use a highly effective contraceptive method. Exclusion Criteria: * The patient has clinically significant distant metastases. * The patient is eligible to have surgical resection or radiotherapy, chemo-radiotherapy or chemotherapy. * The patient has a nasopharyngeal tumour. * The patient has AIDS, hepatitis C or hepatitis B. * The patient has clinically significant renal or hepatic disease. * Tumors are prone to bleeding. * The patient is pregnant or lactating. * The patient requires 'blood thinning' medications and can not safely discontinue the medication. * The patient is currently enrolled in another clinical trial.