A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma
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Memorial Sloan Kettering Cancer Center
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| 追踪信息 | |||
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| 首次提交日期 ICMJE | October 1, 2018 | ||
| 首次发布日期e ICMJE | October 3, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | October 2018 | ||
| 预计主要完成日期 | September 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
number of patients requiring stent replacements[ Time Frame: 1 year ] % frequency liver toxicity[ Time Frame: 1 year ] alkaline phosphatase, serum bilirubin |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma | ||
| 正式标题 ICMJE | 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 | ||
| 简要概况 | 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? |
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| 详细说明 | Group 1 unresectable liver metastases from colorectal cancer - Patients will receive either FOLFIRI, FOLFOX, 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. 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, 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 - Patients will receive Gemcitabine (800 mg/m2 IV over 30 minutes) and Oxaliplatin (85 mg/ m2 IV over 120 minutes) or Gemcitabine (1000 mg/m2 IV over 30 minutes) alone 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. A CT C/A/P every 2 months during treatment. A window of +/- 3 weeks for scans is allowed in order to accommodate patient schedules. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 2 | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: Pilot non- randomized safety study. 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
30 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | September 2020 | ||
| 预计主要完成日期 | September 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease (or) Histologically confirmed cholangiocarcinoma - 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 ≥3.0 K/uL - ANC >1.5 K/uL - Platelets ≥100,000/uL - Creatinine <1.5mg/dL - HGB ≥ 9 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 registration - KPS ≥60% - Patients ≥18 years of age Exclusion Criteria: - Prior radiation to the liver (prior radiation therapy to the pelvis is acceptable if competed at least 4 weeks prior to registration) - 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 registration) - 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: 1. 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 2. Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease 3. Adequately treated cervical carcinoma in situ without evidence of disease | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | ||
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: Yes 研究涉及美国FDA监管的设备产品: Yes |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Memorial Sloan Kettering Cancer Center | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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