NCT01387295已完成2 期
Intra-hepatic Chemotherapy With Oxaliplatin Every Second Week in Combination With Systemic Capecitabine in Patient With Non-resectable Liver Metastases From Breast Cancer A Phase II Trial in Patients With Limited Extrahepatic Disease
Dorte Nielsen1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2010年4月最近更新:
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
- 38
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
This is a phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic capecitabine and in patients with a HER2-positive tumour in combination with trastuzumab (Herceptin®) in patient with non-resectable liver metastases from breast cancer.
Only patients with limited extrahepatic disease are included.
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 confirmed locally advanced or metastatic adenocarcinoma of the breast
- •Liver metastases not suitable for local treatment
- •Extrahepatic disease should be determined by PET-CT-scan.
- •No progression on treatment with capecitabine.
- •Prior treatment with taxane (adjuvant or for metastatic disease)
- •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.
- •INR < 1.
- •If the patient is HER2-positive:Baseline LVEF ≥ 50 %
排除标准
- •History of chemotherapy within the 4-week period prior to the start of trial medication
- •Other current or prior malignant disease except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin.
- •Previous treatment with oxaliplatin
- •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 < or equal to grade 2 or CNS metastases (In case of clinical suspicion on CNS metastases a MR or CT scan should be performed within 4 weeks before inclusion
- •Other severe medical conditions e.g. severe cardial disease or AMI < 1 year
- •Presence of diseases which prevent oral therapy.
- •Patients with uncontrolled infection
- •Pregnant or lactating women
- •Women capable of childbearing not using a sufficient non-hormonal 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
- •If the patient is HER2-positive:
- •Dyspnoea in due to complication related to malignant disease e.g.lung metastases with lymphangitis or other conditions with need of supportive oxygen.
研究组 & 干预措施
chemotherapy
Experimental
干预措施: oxaliplatin, capecitabine, trastuzumab (Drug)
结局指标
主要结局
Response Rate
时间窗: up to 24 months from baseline
Number of patients with complete or partial response in the liver (RECIST version 1.1). Only patients with measurable disease are included in the protocol. Response rate number of patients with CR + PR divided with total number. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions,
次要结局
- Survival(up to 7 years)
- PFS(up to 6 years)
- Number of Patients Suitable for Local Therapy (Radiofrequency)(upon completion of treatment, an average of 7 months)
- Adverse Events(from start of treatment to 28 days after last treatment, an average of 7 months)
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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