NCT02345746撤回2 期
Phase 2 Study of Hepatic Arterial Infusion With Oxaliplatin, Folinic Acid and 5 Fluorouracil Alone or in Combination With Intravenous Chemotherapy in Heavily Pre-Treated Patients With Liver-Predominant Metastasis From Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Determine response rate
研究概览
简要总结
In this study, Hepatic Arterial Infusion will be combined with systemic therapy for patients with liver-only or liver-predominant metastases who have failed at least one line of systemic chemotherapy.
详细描述
In this phase II study, investigators will combine the HAI with systemic therapy for patients with liver-only or liver-predominant metastases who have failed at least one line of systemic chemotherapy. We hypothesize that combination therapy will be able to convert some patients to surgical resection candidates, or/and to overcome chemo-resistance of liver metastases to systemic i.v. chemotherapy for some clinically fit, heavily pre-treated patients
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
- •Performance status ECOG 0-2 and a life expectancy of >3 months.
- •Patients were required to have measurable disease in the liver, defined as lesions measuring >1 cm in largest diameter on spiral-computed tomography (CT) or magnetic resonance imaging (MRI)
- •Histologically confirmed metastatic advanced solid tumors involving the liver, liver replacement less than 70%
- •No bevacizumab (avastin) use within 4 weeks prior to enrollment.
- •Absence of portal vein thrombosis
- •Not a surgical candidate or patients refuse surgery
- •Loss of response to at least two lines of systemic chemotherapy including FU, Oxaliplatin or irinotecan in metastatic setting
- •An asymptomatic extra-hepatic disease is allowed, provided that the extent of the metastatic disease in the liver represented the bulk of the metastatic disease.
- •History of liver-directed therapy is eligible at the investigator's discretion.
- •Adequate renal function with a calculated creatinine clearance greater than 60 mL/min.
- •Hepatic function as follows: Total Bilirubin ≤3 mg/dL, AST ≤5 times upper normal reference value, or ALT ≤ 5 times upper normal reference value.
- •Adequate bone marrow function (ANC ≥1500 cells/uL; PLT ≥ 100,000 cells/uL) before each therapy.
- •At least three weeks from previous immunotherapy, chemotherapy or radiotherapy before being enrolled in this study.
- •All females in childbearing age MUST have a negative serum HCG test unless patients have prior hysterectomy. Women of childbearing potential must take adequate precautions to prevent pregnancy during treatment.
- •Patient consent must be obtained prior to entrance onto study
排除标准
- •Clinical or radiographic evidence of moderate amount of ascites.
- •History of cirrhosis with Child-Pugh class B or C.
- •Pregnant or lactating females.
- •Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
- •Patients receiving any other investigational agents.
- •Patients with bleeding diathesis (clinical bleeding, prothrombin time =/> 1.5 X upper institutional normal value, INR =/> 1.5, activated partial thromboplastin time aPTT =/> 1.5 X upper institutional normal value), active gastric or duodenal ulcer.
- •History of thrombophilia, recurrent DVTs, diagnosis of phospholipid syndrome.
- •Past or current history of malignancy other than colon cancer with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone and a DFS ≥5 years.
- •Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.
- •Patients with clinically significant cardiovascular disease: myocardial infarction or unstable angina within 6 months, New York Heart Association Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, unstable angina pectoris, clinically significant peripheral vascular disease
- •Patients have untreated brain metastasis or leptomeningeal metastases requiring immediate intervention.
研究组 & 干预措施
Hepatic Artery Infusion
Experimental
Hepatic Arterial Infusion (HAI) with the drugs Oxaliplatin, Folinic Acid and 5 Fluorouracil
干预措施: Oxaliplatin (Drug)
Hepatic Artery Infusion
Experimental
Hepatic Arterial Infusion (HAI) with the drugs Oxaliplatin, Folinic Acid and 5 Fluorouracil
干预措施: Folinic Acid (Drug)
Hepatic Artery Infusion
Experimental
Hepatic Arterial Infusion (HAI) with the drugs Oxaliplatin, Folinic Acid and 5 Fluorouracil
干预措施: 5-Fluorouracil (Drug)
结局指标
主要结局
Determine response rate
时间窗: one year
次要结局
未报告次要终点
研究者
Jordan Waypa
Research Director
Western Regional Medical Center
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