Main Criteria for Inclusion:
- Age > 18 years.
- Histologically or cytologically proven pancreatic ductal adenocarcinoma carcinoma or undifferentiated carcinoma of the pancreas.
- Locally advanced or metastatic disease precluding curative surgical resection or patients who have relapsed following previously resected pancreatic cancer
- Contrast enhanced CT scan of the thorax, abdomen and pelvis within 28 days (and up to a maximum of 32 days) prior to commencing treatment.
(Patients who are unable to receive contrast(due to allergies etc) may still be eligible for the trial provided the CT scan still demonstrates measurable disease. Also if, in exceptional circumstances, it is not possible to include a CT scan of the pelvis the patient may still be enrolled into the study. In this instance, no subsequent pelvic CT scans will need to be performed.)
- Unidimensionally measurable disease (from CT scan) in accordance with the RECIST guidelines (Version ?; Appendix 2).
- ECOG performance status 0, 1 or 2.
- Platelets=100 x 109/l; WBC = 3 x 109/l; neutrophils = 1.5 x 109/l at entry.
- Serum bilirubin = 35 ?mol/l
- Calculated creatinine clearance over 50ml/min according to Cockcroft & Gault.
- Life expectancy > 3 months.
- Fully informed written consent given.
Main Criteria for Exclusion:
- Medical or psychiatric conditions compromising informed consent.
- Intracerebral metastases or meningeal carcinomatosis.
- Clinically significant serious disease or organ system disease not currently controlled on present therapy.
- Uncontrolled angina pectoris.
- Pregnancy or breast feeding.
- Previous chemotherapy for locally advanced and metastatic disease. Previously adjuvant chemotherapy for resected pancreatic cancer will be permitted providing chemotherapy was completed more than 12 months previously.
- Radiotherapy within the last 4 weeks prior to start of study treatment.
- Concurrent malignancies or invasive cancers diagnosed within the past 5 years except for adequately treated Basal Cell Carcinoma of the skin, in situ carcinoma of the uterine cervix or resected pancreatic cancer (see Exclusion Criteria: number 6 andInclusion Criteria: number 3)
- Known malabsorption syndromes.
- Patients with a known hypersensitivity to any of the investigational products or patients with a dihydropyrimidine dehydrogenase (DPD) deficiency.
- Medication which might affect immunocompetence e.g. chronic treatment with long term steroids or other immunosuppressant for an unrelated condition. Patients will be eligible if they have been receiving short term steroids for palliation of cancer related symptoms.
- All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom.
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"The experience and treatment I received at the Royal Liverpool Hospital was so
fantastic that I had to tell the people involved with my treatment how marvelous they were,
so please would you pass on my thanks and gratitude to Professor Neoptolemos and his team of
surgeons, the wonderful doctors and nursing staff" - Anon (Participant in ESPAC-3(v2) trial)
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