A Health Service Research Study to Investigate Survival of Metastatic Pancreatic Cancer Patients After Sequential Chemotherapy

Exclusion Criteria

• •1. Serious cardiovascular disease (eg, unstable coronary artery disease or myocardial infarction within 3 months prior to study start)
• •2. Preexisting polyneuropathy (PNP) ≥ grade 3 \[National Cancer Institute Common Toxicity Criteria grade 3 or 4 sensory or motor neuropathy\]
• •3. Prior or concurrent malignancy (other than pancreatic cancer) which either progresses or requires active treatment. Exceptions are: basal cell cancer of the skin
• •4. History of DPD deficiency
• •5. Morbus Gilbert
• •6. History of hypersensitivity to any of the study drugs or any of the constituents of the products
• •7. Medication that is known to interfere with any of the agents applied in the trial
• •8. Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year)
• •9. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
• •10. Any medical condition that contraindicates dosing with any of the IMPs or constitutes a safety risk for the patient including but not limited to:
• •1. chronic inflammatory bowel disease and/or bowel obstruction.
• •2. active uncontrolled infection
• •3. clinically significant bleeding or bleeding diathesis
• •4. clinically significant stomatitis
• •5. active ulceration of the gastrointestinal tract
• •11. Previous enrollment or randomization in the present study (does not include screening failure)
• •12. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG
• •13. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts \[§ 40 Abs. 1 S. 3 Nr. 3a AMG\]