MedDRA - 10033576 C25.9
Conditions
Interventions
Group 1: Trastuzumab 4 mg/kg as initial infusion, followed by 2 mg/kg weekly and Capecitabin 2 x 1250 mg/m2 daily for days 1-14 followed by 7 days pause
repeated every three weeks until tumour progression.
Sponsors
Universitätsklinikum Freiburg
Abteilung Innere Medizin II - Gastroenterologie, Hepatologie, Endokrinologie und Infektiologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Written informed consent - Age over 18 - Histological confirmed diagnoss of a pancreas carcinoma in Stage IVB (T1-4, N0-1, M1) - Staging and CA 19-9 Determiantion not older than 4 weeks - Histologically confirmed overexpression of HER2/neu (immunhistochemical Score 2+ (confirmed by FISH ) or 3+) - At least one measurable or assessable lesion over 2 cm in conventional CT - No previous chemotherapy - No previous radiation therapy - Performance-Status 0 - 2 WHO/ECOG or better 60 Karnofsky - life expectancy at least 3 month - Sufficient renal, hepatic and bonemarrow function, (blood values not older than 1 weel) defined as absolute Neutrophil count greater 1,5 x 10 exp9/l, Hemoglobin greater 80 g/l, platelets greater 100 x 10exp 9 /l, total bilirubin smaller 3-fold upper normal value, creatinine clearance greater 30ml/min (according to Cockroft and Gault), Transaminases smaller 2,5-fold upper normal value, smaller 5-fold upper normal value in case of liver metastases. - LVEF > 50% - infrastructure for regular and longterm followup - Negative pregnancy test for women in reproductive age (done during Screening)
Exclusion criteria
Exclusion criteria: Option of surgical treatment or radiation therapy with curative intention - Known Dihydropyrimidin dehydrogenase (DPD) deficiency - History of known secondary carcinoma with exception of basalioma of skin treated in curative intention or cervical carcinoma in situ - Known hypersensitivity to one of the study medications or their ingredients - Clinical relevant disease of the cardiovascular system or other major organ systems or significant systemic disease, which is incompatible with the procol or complicates the interpretation of the protocol. - Clinically signioficant pulmonary disease - Preexisting polyneuropathy - Simultaneous therapy with the virostatic agent Sorivudin or chemically related substances, for instance Brivudin - Pragnancy, lactation or lack of reliable contraception for women in their reproductive age - Psychiatric disease, addiction or other disease, which keep the patient from understanding character and consequences of the study - Simultaneous participation in a different clinical study within the last 4 weeks - Any disease or therapy, which presens a risk to the patient in the mind of the investigator or is not compatible with the goals of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival rate after 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival - overall survival - - time to remission (complete/partial) - duration of remission - Rate of "Clinical Benefit Response" after 12 weeks - quality of life before therapy and after every second chemotherapy cycle - Toxicity and occurrence of adverse events - impact of CA19-9 serum concentration on progression free survival - correlation between tumour HER2-expression grade and progression free survival | — |
Countries
Germany
Contacts
Public ContactMichael Geißler
Abteilung für Allgemeine Innere Medizin, Onkologie/Hämatologie, Gastroenterologie und Infektiologie
Outcome results
None listed