A Pilot Protocol Evaluating Safety of Using the Medtronic Pump and Codman Catheter for the Delivery of Hepatic Arterial Infusion (HAI) Chemotherapy in Patients With Colorectal Carcinoma or Cholangiocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 7
- 主要终点
- Number of Patients Requiring Stent Replacements
研究概览
简要总结
This study is being done to answer the following question:
Is the combination of the Medtronic pump and the Codman catheter device a safe alternative to the C3000 Codman pump for delivering chemotherapy directly into the liver of patients with metastatic colorectal cancer or cholangiocarcinoma?
详细描述
Group 1 unresectable liver metastases from colorectal cancer
- Patients will receive either FOLFIRI, FOLFOX, Irinotecan or Irinotecan/oxaliplatin (anti- EGFR agent may be added to any of the systemic treatments) on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter. CT C/A/P every 2 months. A window of +/- 3 weeks for scans is allowed in order to accommodate patient schedules.
Group 2 resectable liver metastases from colorectal cancer
- Patients will receive either FOLFIRI, FOLFOX, Irinotecan or Irinotecan/oxaliplatin on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter. Treatment will continue for 6 months in the absence of toxicity or patient withdrawal. CT C/A/P every 3 months. A window of +/- 3 weeks for scans is allowed in order to accommodate patient schedules.
Group 3 unresectable 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
- •History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinicalyl or radiographically confirmed extrahepatic disease (or) Histologically confirmed cholangiocarcinoma (Clinical or radiographic evidence of metastatic disease that has been resected is allowed, provided there is no recurrence in that area prior to protocol consent)
- •Confirmation of diagnosis must be performed at MSKCC
- •Patient may have completely resected hepatic metastases without current evidence of other metastatic disease
- •Lab values ≤14 days prior to registration:
- •WBC ≥2.5 K/uL
- •Platelets ≥100,000/uL
- •Creatinine <1.7mg/dL
- •HGB ≥ 8.5 gm/dL
- •Total Bilirubin ≤1.5 mg/dl
- •Prior chemotherapy is acceptable if last dose given ≥3 weeks prior to registration to this study. [Note: no chemotherapy to be given after resection of liver lesions prior to treatment on this study]
- •Any investigation agent is acceptable if administered ≥3 months before planned first dose on this protocol
- •Patients ≥18 years of age
排除标准
- •Prior radiation to the liver (prior radiation therapy to the pelvis is acceptable if competed at least 4 weeks prior to the planned first dose of treatment on protocol)
- •Active infection, ascites, hepatic encephalopathy
- •Female patients who are pregnant or lactating - or planning to become pregnant within 6 months after the end of the treatment (female patients of child-bearing potential must have negative pregnancy test ≤72 hours before treatment start)
- •If in the opinion of the treating investigator a patient has any serious medical problems which may preclude receiving this type of treatment
- •Patients with current evidence of hepatitis A, B, C (i.e., active hepatitis)
- •Patients with history or known presence of primary CNS tumors, seizures not well-controlled with standard medical therapy, or history of stroke will also be excluded
- •Serious or non-healing active wound, ulcer, or bone fracture
- •History of other malignancy, except:
- •Malignancy treated with curative intent and with no known active disease present for ≥3 years prior to registration and felt to be at low risk for recurrence by the treating physician
- •Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease
- •Adequately treated cervical carcinoma in situ without evidence of disease
- •There is no exclusion of patients based on sex, ethnicity or race. For these reasons, the study results are expected to be generalizable to the Medicare beneficiary population.
研究组 & 干预措施
Pump Therapy
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
干预措施: Medtronic pump and Codman catheter (Device)
Pump Therapy
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
干预措施: Floxuridine (FUDR) (Drug)
Pump Therapy
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
干预措施: Gemcitabine (Drug)
Pump Therapy
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
干预措施: Oxaliplatin (Drug)
Pump Therapy
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
干预措施: Irinotecan (CPT-11) (Drug)
Pump Therapy
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
干预措施: Fluorouracil (Drug)
Pump Therapy
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
干预措施: Anti-EGFR (Panitumumab or Cetuximab) (Drug)
结局指标
主要结局
Number of Patients Requiring Stent Replacements
时间窗: 1 year
Number of Participants With Any Grade Liver Toxicity
时间窗: 1 year
Alkaline phosphatase, serum bilirubin of any patient that received 2 cycles of pump therapy.
次要结局
- Overall Survival at 1 Year Assessed as the Number of Participants Who Were Alive or Dead at 1 Year(1 year)
- Progression Free Survival(up to 3 years)