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Bortezomib and Cetuximab in Treating Patients With Advanced Solid Tumors

2017年11月29日 更新者：Masonic Cancer Center, University of Minnesota

Phase I Study of Bortezomib (Velcade) and Cetuximab (Erbitux) for Patients With Solid Tumors Expressing EGFR

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving bortezomib together with cetuximab may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with cetuximab in treating patients with advanced solid tumors.

研究概览

地位

完全的

条件

干预/治疗

详细说明

OBJECTIVES:

Primary

  • To determine the maximum tolerated dose of bortezomib when given together with cetuximab in patients with advanced solid tumors expressing epidermal growth factor receptor (EGFR).

Secondary

  • To obtain preliminary information about the anti-tumor activity of bortezomib and cetuximab.

OUTLINE: This is a dose-escalation study of bortezomib.

Patients receive bortezomib intravenously (IV) on days 1 and 8 and cetuximab IV over 60-90 minutes on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After the maximum tolerated dose (MTD) is determined, an additional 10 patients are treated at the MTD.

After completion of study treatment, patients are followed periodically for up to 1 year.

研究类型

介入性

注册 (实际的)

37

阶段

  • 阶段1

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
    • Minnesota
      • Minneapolis、Minnesota、美国、55455
        • Masonic Cancer Center at University of Minnesota

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:

  • Diagnosis of solid tumor that overexpresses epidermal growth factor receptor (EGFR) including, but not limited to, the following:

    • Breast cancer
    • Lung cancer
    • Colon cancer
    • Pancreatic cancer
    • Head and neck cancer
    • Kidney cancer
    • Sarcoma

  • Advanced disease

    • Must have failed or become intolerant to prior standard therapy and is no longer likely to respond to such therapy
  • Measurable or nonmeasurable disease
  • ECOG performance status 0-1
  • ANC ≥ 1,500/mm³
  • Platelet count > 100,000/mm³
  • Hemoglobin > 9 g/dL
  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase < 3.0 times ULN (5.0 times ULN if liver has tumor involvement)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (*ALT) < 3.0 times upper limit of normal (ULN) (5.0 times ULN if liver has tumor involvement)
  • Creatinine clearance > 30 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • Recovered from all prior therapy
  • Prior systemic chemotherapy, immunotherapy, or biological therapy allowed
  • At least 14 days since prior radiotherapy or systemic therapy
  • At least 30 days since prior investigational agents
  • At least 14 days since other prior investigational drugs (for reasons other than the treatment of cancer)

Exclusion Criteria:

  • Untreated or symptomatic central nervous system (CNS) metastases
  • Concurrent serious systemic disorders (e.g., active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
  • Uncontrolled diabetes
  • Myocardial infarction within the past 6 months
  • New York Heart Association (NYHA) class III or IV heart failure
  • Uncontrolled angina
  • Severe uncontrolled ventricular arrhythmias
  • Evidence of acute ischemia or active conduction system abnormalities by ECG
  • Peripheral neuropathy Common Terminology Criteria for Adverse Events (CTCAE) grade > 2
  • Known hypersensitivity to bortezomib, boron, or mannitol
  • Serious medical or psychiatric illness likely to interfere with study participation
  • Prior bortezomib and/or cetuximab
  • Concurrent filgrastim (G-CSF) or other hematologic support during course 1 of study treatment

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：非随机化
  • 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：Bortezomib and Cetuximab
The starting dose of bortezomib will be 1.3 mg/m2 with a 0.1 increment increase with each successive dose level to a maximum of 2.0 mg/m2. A loading dose of cetuximab will be given on day 1 (400 mg/m2) followed by a weekly dose of 250 mg/m2.
生物：cetuximab
A loading dose of cetuximab will be given on day 1 (400 mg/m2) followed by a weekly dose of 250 mg/m2.
其他名称：
  • 爱必妥
药品：bortezomib
The starting dose of bortezomib will be 1.3 mg/m2 with a 0.1 increment increase with each successive dose level to a maximum of 2.0 mg/m2.
其他名称：
  • 万珂

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
Maximum tolerated dose (MTD) of bortezomib
大体时间：At end of Cycle 1 (Week 3)
The standard Phase I design will be used to determine the maximum tolerated dose of bortezomib when given with weekly cetuximab. The MTD is defined as the highest dose studied for which the incidence of dose limiting toxicity (DLT) was less than 33%.
At end of Cycle 1 (Week 3)

次要结果测量

结果测量
措施说明
大体时间
Disease response as measured by RECIST criteria
大体时间：At Week 4
The best overall response is the best response recorded from registration until disease progression/recurrence, taking as reference for progressive disease the smallest measurements recorded since registration.
At Week 4

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

Masonic Cancer Center, University of Minnesota

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

2005年11月1日

初级完成 (实际的)

2009年8月1日

研究完成 (实际的)

2010年2月1日

研究注册日期

首次提交

2008年2月22日

首先提交符合 QC 标准的

2008年2月22日

首次发布 (估计)

2008年2月25日

研究记录更新

最后更新发布 (实际的)

2017年12月2日

上次提交的符合 QC 标准的更新

2017年11月29日

最后验证

2010年4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

  • CDR0000586671
  • UMN-2005LS037 (其他标识符：CPRC, University of Minnesota)
  • MILLENNIUM-X05160 (其他标识符：Millennium Pharm Inc.)
  • UMN-0506M7030372 (其他标识符：IRB, University of Minnesota)

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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