NCT01312857已完成2 期
A Randomized Phase II Study of Hepatic Arterial Infusion With Intravenous Irinotecan, 5FU and Leucovorin With or Without Panitumumab, in Patients With Wild Type RAS Who Have Resected Hepatic Metastases From Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 8
- 主要终点
- Participants With Recurrence Free Survival for Colorectal Cancer Participants With Resected Liver Metastases
研究概览
简要总结
The purpose of this study is to see if Panitumumab plus the other treatments will increase the time of remission. Remission means that there is no sign of the cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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.
- •Completely resected hepatic metastases without current evidence of other metastatic disease.
- •Lab values ≤ 14 days prior to treatment start:
- •WBC ≥ 3.0 K/uL
- •ANC > 1.5 K/uL
- •Platelets ≥ 100,000/uL
- •Creatinine <1.5 mg/dL
- •HGB ≥ 9 gm/dL Renal function (≤ 14 days prior to treatment start).
- •Creatinine ≤1.5 mg/dL or creatinine clearance ≥ 50 mL/min calculated by the
- •Cockcroft-Gault method as follows:
- •Male creatinine clearance = (140 -age in years) x (weight in Kg) / (serum Cr in mg/dl x 72)
- •Female creatinine clearance = (140 - age in years) x (weight in Kg) x 0.85 / (serum Cr in mg/dl x 72) (use of creatinine clearance per protocol based on chemotherapy regimen) Hepatic function, as follows: (≤ 14 days prior to treatment start)
- •Aspartate aminotransferase (AST) (≤ 5 x ULN)
- •Alanine aminotransferase (ALT) (≤ 5 x ULN)
- •Total Bilirubin ≤ 1.5 mg/dl
- •Magnesium ≥ lower limit of normal (≤ 48 hours prior to treatment start.)
- •Calcium ≥ lower limit of normal (≤ 48 hours prior to treatment start.)
- •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 investigational agent is acceptable if administered ≤ 30 days before registration
- •KPS ≥ 60% (ECOG (or Karnofsky) performance status (preferably 0 or 1/≥ 60% for Karnofsky)
- •Histologically confirmed all RAS wild type.
- •Paraffin-embedded tumor tissue obtained from the primary tumor or metastasis (Prior to
排除标准
- •Patients < 18 years of age.
- •Prior radiation to the liver (Prior radiation therapy to the pelvis is acceptable if completed at least 4 weeks prior to registration.)
- •Active infection, ascites, hepatic encephalopathy.
- •Prior treatment with HAI FUDR.
- •Patients who have had prior anti EGFR antibody therapy inhibitors and who have not responded to this treatment will be excluded. However, patients who have responded to prior anti-EGFR therapy are eligible.)
- •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 a patient has any serious medical problems which may preclude receiving this type of treatment.
- •Patients with current evidence of hepatitis A, B, C (ie, 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.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to Panitumumab.
- •Serious or non-healing active wound, ulcer, or bone fracture.
- •History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
- •Patients who have a diagnosis of Gilbert's disease.
- •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
研究组 & 干预措施
Randomization to panitumumab
Experimental
Patients whose liver metastases have been completely resected will be randomized Arm A will receive Panitumumab in addition to HAI FUDR/Dexamethasone plus systemic CPT-11/5FU/LV
干预措施: panitumumab (Drug)
Randomization to No Panitumumab
Experimental
Patients whose liver metastases have been completely resected will be randomized and patients randomized to Arm B will receive HAI FUDR/Dex plus systemic CPT-11/5FU/LV alone.
干预措施: Randomization to No Panitumumab (Drug)
结局指标
主要结局
Participants With Recurrence Free Survival for Colorectal Cancer Participants With Resected Liver Metastases
时间窗: 15 months
to determine if panitumumab with Hepatic Arterial Infusion (HAI) in combination with systemic chemotherapy can increase the recurrence free survival (RFS) for colorectal cancer patients with resected liver metastases
次要结局
- Number of Participants Evaluated for Toxicity as Per the NCI Common Toxicity Criteria(2 years)
- Participant Survival(2 years)
- Number of Participants With Tumor Tissue Expression of Predictive Makers(2 years)
研究者
研究点 (8)
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