EUCTR2008-007686-24-NL进行中（未招募）不适用
A phase I/ II, non-randomized, feasibility/ safety and efficacy study of the combination of everolimus, cetuximab and capecitabine in patients with metastatic pancreatic cancer - CEC
未提供0 个研究点目标入组 35 人开始时间: 2008年11月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 35
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
- •-Signed informed content obtained prior to treatment
- •-Cytological or histological confirmed adenocarcinoma of the pancreas
- •-Metastatic pancreatic cancer
- •-Measurable lesion according to RECIST criteria (see Appendix)
- •-ECOG/ WHO performance 0-2 (see Appendix)
- •-Age > 18 years
- •-Life expectancy > 3 months
- •-Adequate renal function (creatinine < 150 µmol/L)
- •-Adequate liver function (bilirubin < 2.5 times upper limit of normal, ALAT or ASAT < 5.0 times upper limit of normal in case of liver metastases and < 2.5 the upper limit of normal in absence of liver metastases
- •-Adequate bone marrow function (WBC > 3.0 x 10 9/L, platelets > 100 x 10 9/L)
- •-Mentally, physically, and geographically able to undergo treatment and follow up
- •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
- •-Clinical or radiological evidence of CNS metastases
- •-Pregnancy (positive serum pregnancy test) or patients (male/female) with reproductive potential (without effective contraception) or lactation
- •-Concomitent treatment with other experimental drugs or any other anticancer therapy
- •-Previous treatment with cetuximab
- •-Other malignancy within the last 5 years, except adequately treated basocellular skin carcinoma or cervical carcinoma
- •-Medical or physiological conditions that would not permit the subject to complete the study or sign informed consent
- •-Serious concomitant systemic disorder that would compromise the safety of the patient, at the discretion of the investigator
研究者
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