DRKS00000600进行中（未招募）2 期
Multicenter Phase-II-Study with Capecitabine/Trastuzumab as first-line therapy for advanced HER2-overexpressing pancreas carcinoma - ML17-743
niversitätsklinikum FreiburgAbteilung Innere Medizin II - Gastroenterologie, Hepatologie, Endokrinologie und Infektiologie0 个研究点目标入组 17 人开始时间: 2010年11月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 17
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •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)
排除标准
- •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
研究者
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