A prospective, non-randomised phase II study of trastuzumab and capecitabine in patients with HER2 expressing advanced pancreatic cancer

Roche Pharma AG (Germany)0 个研究点目标入组 37 人开始时间: 2008年5月30日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•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

•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

发起方

Roche Pharma AG (Germany)