Inclusion criteria | Exclusion criteria |
---|---|
1. written informed consent | 1. possible surgical resection and/or radiotherapy with curative potential |
2. age 18 years or older | 2. dihydropyrimidine-dehydrogenase deficiency |
3. histological verified pancreatic cancer in stage IVB (T1–4N0M1) | 3. gastrointestinal obstruction |
4. staging and CA19-9 serum level not older than 4 weeks | 4. a known secondary neoplasm except a curative treatable basalioma of the skin or carcinoma in situ of the cervix uteri |
5. histological verified over-expression of HER2/neu (immunological score 3+ or 2+ and HER2/neu gene amplification in FISH analysis) | 5. a known hypersensitivity against any of the applied substances |
6. at least one measurable lesion (≥ 2 cm in conventional CT scan or ≥ 1 cm in spiral CT scans) | 6. clinically relevant disorder of the cardio-vascular system or other organs or a severe systemic disease that compromises the study protocol or the interpretation of the data |
7. no prior radiation or chemotherapy | 7. clinically manifest pulmonary disorder |
8. performance-status 0–2 according to WHO/ECOG or ≥ 60 points on the Karnofsky scale | 8. prior polyneuropathy |
9. life expectancy of at least 3 months | 9. a concomitant treatment with the virusstatic agents Sorivudin or its analogues |
10. Left ventricular excretion fraction > 50% | 10. pregnancy, breast feeding or absence of appropriate contraceptive measures |
11. appropriate renal, liver and hematopoetic function defined by: | 11. psychiatric disorders, drug abuse or other disorders, that compromise the informed consent |
a. neutrophils ≥ 1.5 × 109/l | |
b. hemoglobin ≥ 80 g/l | |
c. platelets ≥ 100 × 109/l | |
d. total bilirubin < 3 × normal | |
e. creatinine clearance ≥ 30 ml/min (Cockroft Gault) | |
f. transaminases | |
i. < 2.5 × normal | |
ii. < 5 × normal in case of liver metastases | |
12. possibility of long-term follow up | 12. concomitant participation in other clinical trials or participation within the last 4 weeks |
13. negative pregnancy testing | 13. any other disorder or treatment that poses a risk to the patient or is incompatible with the aims of this study |