| Exclusion Criteria: | 1) Significant residual neurological or cardiac toxicity (greater than or equal to grade 2) following previous chemotherapy. In addition, patients who have received prior anthracyclines should not be enrolled if their total cumulative dosage is approaching that likely to cause cardiotoxicity.
2) Have received chemotherapy or wide-field radiation therapy (e.g.>/= 30% of marrow bearing bones) within 4 weeks prior to study entry, or focal radiation within 2 weeks prior to study entry, or have planned surgery. Patient must have recovered or stabilized from all adverse effects of prior radiotherapy.
3) Concurrently receiving other anti-neoplastic treatment (chemotherapy, radiotherapy or immunotherapy including steroid therapy).
4) Myocardial infarction within 6 months of study entry, unstable angina pectoris, uncontrolled congestive heart failure, uncontrolled arrhythmia, severe aortic stenosis, a history of multiple sclerosis, or other demyeliminating disease, Eaton-Lambert syndrome, history of haemorrhagic stroke, any CNS injury with residual neurologic deficit, ischaemic stroke within the last 6 months, history of pancreatitis, current active varicella-zoster virus (shingles) or cytomegalovirus infection, chronic alcoholism, serious concomitant infection or any other concomitant illness.
5) Other investigational agents during the study or within 4 weeks prior to study entry.
6) Known hypersensitivity to previous monoclonal antibody therapy.
7) Patients with active brain metastases. However, patients with well treated central nervous system metastases are eligible as long as there is no evidence of active disease and there is no requirement for anticonvulsant medications or steroids to control residual symptoms.
8) Previous malignancy with less than 3 year disease-free interval from the last therapeutic intervention, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
9) Unwilling or unable to tolerate and comply with the requirements of the study.
10) Pregnant of lactating females.
11) Patients who have any known recent biochemical or clinical evidence of pancreatitis or extensive metastatic disease involving the pancreas will be excluded. (Enrolment of patients with metastatic disease to, or around, the pancreas may be allowed only with agreement between the Medical Monitor and the Investigator). |