An Open, Single-center Study to Determine the Antibody Repsonse to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma

Inclusion criteria

• Patients with histological or cytological confirmation of pancreatic carcinoma who were not suitable for pancreatic tumour resection with curative intent
• Patients who had not received chemotherapy in the previous month and who would either not receive chemotherapy in the period of study or who would commence gemcitabine treatment in week 4 of the study
• Male or female patients over 18 years of age
• Patients with a life expectancy of at least 2 months
• Patients must have given written informed consent
• Patients with a Karnofsky Performance Status score of ≥ 50%
• Patients who would not receive chemotherapy in the period of the Extension Survival Study, except for concomitant gemcitabine ongoing at visit (for extension study)

Exclusion criteria

• History of other malignant disease except non-melanomatous skin carcinoma or in situ carcinoma of the uterine cervix
• Concomitant use or anticipated use in the period of the study of radiotherapy
• Chemotherapy in the previous month preceding screening, anticipated concomitant use of chemotherapy between screening and week 4 of the study or anticipated useof chemotherapeutic agents other than gemcitabine from week 4 for the period of the study
• Use in the past month or concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids
• Females who were pregnant, planning to become pregnant or lactating
• Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during the study
• Haematological indicators:

Haemoglobin <9.5g/dl White blood cell count <3.5 x 109/l Platelets <100 x 109/l