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.