Advanced pancreatic cancer (stage IVb) Cancer Pancreatic cancer
Conditions
Interventions
The trastuzumab loading dose of 4 mg/kg body weight will be given on day one over 90 minutes. For maintenance therapy a weekly dose of 2 mg/kg body weight over 30 minutes will be infused until tumour
Sponsors
Roche Pharma AG (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Aged 18 years or older, either sex 3. Histological verified pancreatic cancer in stage IVb (T1-4N0M1) 4. Staging and CA19-9 serum level not older than four weeks 5. Histological verified over-expression of HER2/neu (immunological score 3+ or 2+ with verification by fluorescent in situ hybridisation [FISH]) 6. At least one measurable lesion (greater than or equal to 2 cm in conventional computed tomography [CT] scan or greater than or equal to 1 cm in spiral CT scans) 7. No prior chemotherapy 8. No prior radiotherapy 9. Performace-status 0 - 2 according to World Health Organization [WHO]/Eastern Cooperative Oncology Group [ECOG] or greater than or equal to 60 points on the Karnofsky scale 10. Life expectancy of at least three months 11. Left ventricular excretion fraction greater than 50% 12. Appropriate renal, liver and haematopoetic function defined by: 12.1. Neutrophils greater than or equal to 1.5 x 10^9/l 12.2. Haemoglobin greater than or equal to 80 g/l 12.3. Platelets greater than or equal to 100 x 10^9/l 12.4. Total bilirubin less than 3 x normal 12.5. Creatinine clearance greater than or equal to 30 ml/min (Cockroft Gault) 12.6. Transaminases either less than 2.5 x normal, or less than 5 x normal in case of liver metastasis 13. Possibility of long-term follow up 14. Negative pregnancy testing
Exclusion criteria
Exclusion criteria: 1. Possible surgical resection and/or radiotherapy with curative potential 2. Dihydropyrimidine-dehydrogenase deficiency 3. Gastrointestinal obstruction 4. A known secondary neoplasm except a curative treatable basalioma of the skin or carcinoma in situ of the cervix uteri 5. A known hypersensitivity against any of the applied substances 6. Clinically relevant disorder of the cardiovascular system or other organs or a severe systemic disease that compromises the study protocol or the interpretation of the data 7. Clinically manifest pulmonary disorder 8. Prior polyneuropathy 9. A concomitant treatment with the virustatic agents sorivudin or its analogues 10. Pregnancy, breast feeding or absence of appropriate contraceptive measures 11. Psychiatric disorders, drug abuse or other disorders, that compromise the informed consent 12. Concomitant participation in other clinical trials or participation within the last four weeks 13. Any other disorder or treatment that poses a risk to the patient or is incompatible with the aims of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival after 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression free survival time 2. Overall survival 3. Time until remission (partial or complete) 4. Duration of remission 5. Rate of 'clinical benefit response' after 12 weeks 6. Quality of life before treatment and after two cycles of chemotherapy Additional secondary trial endpoints: 7. Toxicity analysis 8. The rate of adverse events 9. The relationship between progression free survival and CA19-9 plasma levels 10. The relation between HER2/neu overexpression and progression free survival | — |
Countries
Germany
Outcome results
None listed