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Table 1 List of the eligibility criteria

From: A prospective, non-randomized phase II trial of Trastuzumab and Capecitabine in patients with HER2 expressing metastasized pancreatic cancer

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