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FOLFOXIRI Plus Panitumumab Patients With Metastatic KRAS Wild-Type Colorectal Cancer With Liver Metastases Only

2015年5月7日 更新者：SCRI Development Innovations, LLC

A Phase II Study of FOLFOXIRI Plus Panitumumab Followed by Evaluation for Resection, in Patients With Metastatic KRAS Wild-Type Colorectal Cancer With Liver Metastases Only

In this Phase II study the investigators plan to determine the overall response rate (ORR) of the combination of FOLFOXIRI plus panitumumab as first-line treatment of patients with liver-only metastatic KRAS wild-type colorectal cancer.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Further data has emerged showing a consistent lack of efficacy using EGFR inhibitor panitumumab in combination with chemotherapy in the treatment of patients with KRAS mutant colorectal cancer. For patients with liver-only metastatic colorectal cancer, improvement in response rates with newer chemotherapy regimens has led to a larger percentage of patients eligible for surgical resection. Treatment with FOLFOXIRI improves response rates when compared to FOLFIRI. Similarly, the addition of an EGFR inhibitor improves the response rate of FOLFIRI in patients with wild-type KRAS. In this trial, we will attempt to maximize the response rate and the surgical resection rate by using FOLFOXIRI and panitumumab.

研究类型

介入性

注册 (实际的)

15

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Arkansas
      • Jonesboro、Arkansas、美国、72401
        • NEA Baptist Clinic
    • Florida
      • Ft. Myers、Florida、美国、33916
        • Florida Cancer Specialists
      • Orlando、Florida、美国、32804
        • Florida Hospital Cancer Institute
      • St. Petersburg、Florida、美国、33705
        • Florida Cancer Specialists
    • Georgia
      • Gainesville、Georgia、美国、30501
        • Northeast Georgia Medical Center
    • Indiana
      • Terre Haute、Indiana、美国、47802
        • Providence Medical Group
      • Terre Haute、Indiana、美国、47802
        • Hope Cancer Center
    • Maryland
      • Bethesda、Maryland、美国、20817
        • Center for Cancer and Blood Disorders
    • New Hampshire
      • Portsmouth、New Hampshire、美国、03801
        • Portsmouth Regional Hospital
    • New Jersey
      • Morristown、New Jersey、美国、07960
        • Hematology-Oncology Associates of Northern NJ
    • Ohio
      • Cincinnati、Ohio、美国、45242
        • Oncology Hematology Care, Inc
    • Tennessee
      • Chattanooga、Tennessee、美国、37404
        • Chattanooga Oncology Hematology Associates
      • Collierville、Tennessee、美国、38017
        • Family Cancer Center
      • Nashville、Tennessee、美国、37203
        • Tennessee Oncology, PLLC
    • Texas
      • Fort Worth、Texas、美国、76104
        • The Center for Cancer and Blood Disorders

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Patient must have a biopsy confirmed adenocarcinoma of the colon or rectum with stage IV (metastatic) liver-only disease, as defined by staging with CT scans.
  2. Patients must have a baseline evaluation to determine whether liver metastases are resectable (e.g. a single liver metastasis in a resectable location)or unresectable (surgical consultation is recommended). Both groups are eligible for this study.
  3. Tumor tissue must reveal wild-type KRAS expression (i.e. no KRAS mutation) prior to study entry (see Section 7.4.4.).
  4. Patients must have at least one unidimensional measurable lesion definable by CT scan. Disease must be measurable per RECIST version 1.1 criteria (see Section 9).
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (see Appendix A).

  6. Laboratory values as follows:

    ANC greater than 1500/μL

    Hgb greater than9 g/dL

    Platelets greater than 100,000/μL

    AST/SGOT less than 5.0 x ULN

    ALT/SGPT less than or equal to 5.0 x ULN

    Alk Phos less than or equal to 5.0 x ULN

    Bilirubin less than or equal to 1.5 x ULN

    Creatinine 1.5 mg/dL or calculated creatinine clearance 50 ml/min

    Magnesium LLN

  7. Patient must have a life expectancy of greater than 12 weeks.
  8. Patient must be greater than or equal to 18 years of age.
  9. Patient must be accessible for treatment and follow-up.
  10. Women of childbearing potential must have a negative serum or urine pregnancy test performed less than or equal to 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment and during the 6 months following completion of study treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
  11. Patient must be able to understand the nature of the study and give written informed consent prior to study entry.

Exclusion Criteria:

  1. Prior systemic therapy for metastatic colorectal cancer (including chemotherapy, bevacizumab, cetuximab, panitumumab, and other targeted agents).
  2. Adjuvant chemotherapy (and/or chemoradiation) for colorectal carcinoma ending less than or equal to 12 months prior to the diagnosis of metastatic cancer. Prior radiation therapy (in the metastatic setting) may be allowed if it was completed greater than or equal to 4 weeks prior to enrollment and measurable lesions are outside the radiation portal site.
  3. Any detectable metastases in areas other than the liver.
  4. Known liver disease or other significant medical illness that would exclude the patient as a candidate for resection of liver metastases.
  5. Patients requiring therapeutic coumadin or heparin (for a history of pulmonary emboli or deep vein thrombosis [DVT]) will be excluded.
  6. Patients who have had a major surgical procedure (not including mediastinoscopy), open biopsy, or significant traumatic injury less than or equal to 4 weeks prior to beginning treatment.
  7. History of Gilbert's disease.
  8. History of hypersensitivity to active or inactive excipients of any component of treatment (5 fluorouracil, irinotecan, panitumumab, and/or oxaliplatin), or known dipyrimidine dehydrogenase (DPD) deficiency
  9. Serious cardiac arrhythmia requiring medication.
  10. Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, an infection requiring IV antibiotics, or psychiatric illness/social situations that would limit compliance with study requirements.
  11. Patient with known diagnosis of human immunodeficiency virus (HIV), hepatitis C virus or acute or chronic hepatitis B infection.
  12. Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
  13. Use of any non-approved or investigational agent less than or equal to 28 days prior to administration of the first dose of study drug.
  14. Past or current history of neoplasm other than the entry diagnosis 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 greater than or equal to 5 years.
  15. Patients with National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (NCI CTCAE) Grade 2 peripheral neuropathy.
  16. Female patients who are pregnant or lactating.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：FOLFOXIRI+panitumumab regimen

All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:

  • Panitumumab
  • Oxaliplatin
  • Irinotecan
  • Leucovorin
  • 5-Fluorouracil
药品：Panitumumab
6 mg/kg, 60-90 minute IV infusion every 2 weeks
其他名称：
  • 综合治疗
药品：Oxaliplatin
85 mg/m2, 2-hour IV infusion every 2 weeks
其他名称：
  • 综合治疗
药品：Irinotecan
125 mg/m2, 1-hour IV infusion every 2 weeks
其他名称：
  • 综合治疗
药品：Leucovorin
200 mg/m2, 2-hour IV infusion every 2 weeks
其他名称：
  • 综合治疗
药品：5-Fluorouracil
3200 mg/m2 IV, 48-hour continuous infusion every two weeks
其他名称：
  • 综合治疗

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Overall Response Rate (ORR)
大体时间：18 months
The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
18 months

次要结果测量

结果测量
措施说明
大体时间
总生存期（OS）
大体时间：18个月
患者从接受方案治疗的第一天到死亡的存活时间（以月为单位）
18个月
Progression-free Survival (PFS)
大体时间：18 months
The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
18 months
R0 Resection Rate
大体时间：18 months
To determine the rate of complete (R0) resection for patients treated with this regimen.
18 months
To Determine the Acute Toxicity Produced by This Regimen.
大体时间：18 months
The analyses of safety will be based on the frequency of adverse events and their severity for patients who received at least one dose of study treatment.
18 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

SCRI Development Innovations, LLC

合作者

Amgen

调查人员

  • 学习椅：Johanna Bendell, MD、SCRI Development Innovations, LLC

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年12月1日

初级完成 (实际的)

2014年3月1日

研究完成 (实际的)

2014年3月1日

研究注册日期

首次提交

2010年10月15日

首先提交符合 QC 标准的

2010年10月20日

首次发布 (估计)

2010年10月22日

研究记录更新

最后更新发布 (估计)

2015年5月27日

上次提交的符合 QC 标准的更新

2015年5月7日

最后验证

2015年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • SCRI GI 134

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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