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/orradiotherapy, chemo-radiotherapy or chemotherapy).

• The patient must have been diagnosed with persistent or recurrent disease or a secondprimary tumour.

• The patient's disease must be refractory.

• There must be at least 2 weeks between the last dose of chemotherapy or radiotherapyand receiving study drug or 4 weeks between the last dose of an experimental drug andreceiving study drug. Patient Characteristics

• The patient must have adequate hepatic function [alanine aminotransferase (ALT) andaspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN) and bilirubinlevel ≤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 normallimits. Other

• Women of childbearing potential and male patients must agree to use a highly effectivecontraceptive method.

Exclusion Criteria:

• The patient has clinically significant distant metastases.

• The patient is eligible to have surgical resection or radiotherapy, chemo-radiotherapyor 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 themedication.

• The patient is currently enrolled in another clinical trial.