Multicenter Phase-II-Study with Capecitabine/Trastuzumab as first-line therapy for advanced HER2-overexpressing pancreas carcinoma
- Conditions
- MedDRA - 10033576C25.9Pancreas, unspecified
- Registration Number
- DRKS00000600
- Lead Sponsor
- niversitätsklinikum FreiburgAbteilung Innere Medizin II - Gastroenterologie, Hepatologie, Endokrinologie und Infektiologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 17
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)
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method progression free survival rate after 12 weeks
- Secondary Outcome Measures
Name Time Method progression free survival<br>- overall survival -<br>- time to remission (complete/partial)<br>- duration of remission <br>- Rate of Clinical Benefit Response after 12 weeks<br>- quality of life before therapy and after every second chemotherapy cycle<br>- Toxicity and occurrence of adverse events<br>- impact of CA19-9 serum concentration on progression free survival<br>- correlation between tumour HER2-expression grade and progression free survival<br>