EUCTR2008-003174-18-DE进行中（未招募）1 期
Open-labeled, randomized multi-center phase II study evaluating the efficacy and safety of Paclitaxel/ Carboplatin with and without Cetuximab as first-line treatment of adeno- and undifferentiated carcinoma of unknown primary (CUP)
niversitätsklinikum Heidelberg0 个研究点目标入组 150 人开始时间: 2008年12月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Histologically or cytologically proven, non-resectable carcinoma of unknown primary (adenocarcinoma or non-differentiated carcinoma)
- •-Measurable tumor lesion(s) according to RECIST criteria
- •-WHO PS 0 to 1
- •-Signed written informed consent
- •-=18 years of age
- •-Effective contraception for both male and female subjects if the risk of conception exists
- •-Adequate bone marrow function: Neutrophil blood cell count (NBC) = 1,5x109/L, platelet count = 100x109/L, hemoglobin = 5,00 mmol/L (8 g/dL)
- •-Adequate liver and renal function: bilirubin = 1,5 x upper normal level (UNL) and not increasing more than 25% within the last 4 weeks, ASAT and ALAT = 2,5 x UNL or in case of liver metastases = 5 x UNL. Serum creatinine = 1.5 x UNL
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Previous exposure to epidermal growth factor receptor-targeting therapy
- •-Previous chemotherapy except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment
- •-Radiotherapy (> 30 Gy) major abdominal or thoracic surgery within the last 4 weeks before inclusion
- •-Concurrent chronic systemic immunotherapy, chemotherapy or hormone therapy.
- •-Investigational agents or participation in clinical trials within 30 days before treatment start in this study
- •-Clinically relevant coronary disease or myocardial infarction within 12 months before study entry
- •-Possibility of a curative local treatment (surgery and/or radiotherapy)
- •-Women with axillary node metastasis as predominant tumor site
- •-Women with peritoneal carcinomatosis as predominant tumor site
- •-Men < 50 y. with retroperitoneal or mediastinal lymph node +/- lung metastases as predominant tumor site
- •-Identification of the primary or suspicion of a specific tumor entity by reference histopathology (i.e. Her-2 positive or hormone receptor positive tumors corresponding to breast cancer, CK7-negative/CK20-positive tumors with high probability for colorectal cancer)
- •-Peripheral neuropathy > CTC grade I
- •-Previous malignancy within the last 5 years (except history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment)
- •-History of severe psychiatric illness
- •-Life expectancy less than six weeks
- •-Drug or alcohol abuse
- •-Known hypersensitivity reaction to any of the components of the study treatment
- •-Pregnancy (absence to be confirmed by ß-hCG test) or lactation period
- •-Brain metastasis and/or leptomeningeal disease (known or suspected)
- •-Acute or sub-acute intestinal occlusion or inflammatory bowel disease
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