A Phase I Study of Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Intravenous Oxaliplatin Plus Irinotecan in Patients With Unresectable Hepatic Metastases From Colorectal Cancer.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Determine the MTD of hepatic arterial floxuridine (FUDR) & dexamethasone (Dex) given via implanted pump in combination w biweekly intravenous Oxaliplatin + systemic irinotecan (CPT-11) in patients w unresectable hepatic metastases from colorectal cancer.
研究概览
简要总结
The purpose of this study is to see how well patients tolerate the side effects of treatment with Floxuridine, Oxaliplatin and Irinotecan. We also want to know if these methods used together are a useful way of treating cancer. We have studied these drugs and know the best doses of each when they are used alone. We do not yet know how well the drugs work with each other. This study will tell us the best doses of each drug when they are given over the same period of time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease.
- •Confirmation of diagnosis must be performed at MSKCC.
- •Patient's liver metastases must be deemed unresectable and comprise <70% of the liver parenchyma.
- •A patient may have had prior chemotherapy or be previously untreated.
- •Patient may not have received prior treatment with FUDR or >2 doses of Oxaliplatin.
- •KPS > or = to 60%.
- •WBC > or = to 3,000 cells/mm3 and platelet count > or = to 100,000 cells/mm3 within 14 days of registration.
- •Creatinine < or = to 1.5 mg/dl within 14 days of registration.
- •Total serum bilirubin < or = 2.0 mg/dl within 14 days of registration.
排除标准
- •No active concurrent malignancies: except a patient's potentially resectable colorectal primary.
- •Patient must not have obstruction of GI or GU tract.
- •Patient must not have current, symptomatic peripheral sensory neuropathy.
- •No prior radiation to liver.
- •No active infection, ascites, or hepatic encephalopathy.
- •Age ≥ 18 years.
- •Female patients cannot be pregnant or lactating.
- •Signed informed consent.
研究组 & 干预措施
1
Patients will undergo pump placement and biopsy of diseased liver tissue. Chemotherapy will be initiated as soon as possible following verification of adequate pump placement and perfusion by radiographic pump study. Treatment will continue indefinitely unless a patient experiences a treatment endpoint.
干预措施: Floxuridine, Oxaliplatin, CPT-11 (Drug)
2
Patients will undergo pump placement and biopsy of diseased liver tissue. Chemotherapy will be initiated as soon as possible following verification of adequate pump placement and perfusion by radiographic pump study. Treatment will continue indefinitely unless a patient experiences a treatment endpoint.
干预措施: Floxuridine, Oxaliplatin, CPT-11 (Drug)
结局指标
主要结局
Determine the MTD of hepatic arterial floxuridine (FUDR) & dexamethasone (Dex) given via implanted pump in combination w biweekly intravenous Oxaliplatin + systemic irinotecan (CPT-11) in patients w unresectable hepatic metastases from colorectal cancer.
时间窗: conclusion of the study
次要结局
- To determine the preliminary anti-tumor activity of the aforementioned combination chemotherapy.(conclusion of the study)
- To procure normal and disease liver tissue for evaluation of TS, p53, p21, TOPO 1, DPD, and ERCC levels.(conclusion of the study)