NCT01247337已完成2 期
Intra-hepatic Chemotherapy With Oxaliplatin Every Second Week in Combination With Systemic Gemcitabine and Capecitabine in Combination With Cetuximab in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma. A Phase II Trial.
Dorte Nielsen1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2011年2月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
A phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic gemcitabine and capecitabine in combination with cetuximab in patient with non-resectable liver metastases from cholangiocarcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Age > 18 years
- •Performance status 0-1; expected survival ≥ 3 months
- •Patient with histologically or cytologically adenocarcinoma developed from cells in the gall bladder, extra- or intrahepatic bile ducts or malignant cells consistent with above mentioned and radiologic findings consistent with cholangiocarcinoma
- •Liver metastases not suitable for surgery or other local treatment
- •Extrahepatic disease should be excluded by PET-CT-scan.
- •Prior treatment with chemotherapy or no progression on first line treatment
- •Metastases < 70 % of the liver
- •neutrophile granulocytes ≥ 1.5 x 109/l og thrombocytes ≥ 100 x 109/l
- •bilirubin < 2.0 x UNL (upper normal limit).
- •creatinine-clearance ≥ 30 ml/min.
- •Intrahepatic treatment can be accomplished
- •The patients is approved by a multidisciplinary team
排除标准
- •Other current or prior malignant disease except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin.
- •Cytotoxic or experimental treatment within a 14 days period before start of trial medication
- •The patient is not allowed to participate in other clinical trials.
- •Any clinical symptoms suggesting peripheral neuropathy grade 2
- •Other severe medical conditions
- •Severe cardial disease or AMI < 1 year
- •Presence of diseases preventing oral therapy
- •Patients with uncontrolled infection
- •Pregnant or lactating women
- •Women capable of childbearing not using a sufficient method of birth control
- •Patients not able to understand the treatment or to collaborate
- •Prior serious or unsuspected reaction after treatment with fluoropyrimidine
- •Known prior hypersensitivity reactions to the agents
- •Interstitial pneumonitis or pulmonary fibrosis
研究组 & 干预措施
Single arm chemotherapy treatment
Experimental
干预措施: Oxaliplatin, capecitabine, gemcitabine, cetuximab (Drug)
Single arm chemotherapy treatment
Experimental
干预措施: Oxaliplatin, capecitabine, gemcitabine cetuximab (Drug)
结局指标
主要结局
PFS
时间窗: 6 months after last patient included
Time from treatment start to progression or death.
次要结局
- Response rate.(6 months after last patient included)
- Toxicity(28 days after last treatment of last patient)
- Survival(6 months after last patient included)
研究者
Dorte Nielsen
Responsible Party was entered in the old format as Dorte Nielsen, professor DMSci, Department of Oncology, Herlev Hospital.
Herlev Hospital
研究点 (1)
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