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Monoclonal Antibody ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction Cancer

2013年1月7日 更新者:Jonsson Comprehensive Cancer Center

An Open Label, Multiple Dose, Dose-Rising Clinical Trial of the Safety of ABX-EGF in Patients With Renal, Prostate, Pancreatic, Non-Small-Cell Lung, Colorectal, or Esophageal Cancer

RATIONALE: Monoclonal antibodies such as ABX-EGF can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody ABX-EGF in treating patients who have either renal (kidney), prostate, pancreatic, non-small cell lung, colon, rectal, esophageal, or gastroesophageal junction cancer.

研究概览

详细说明

OBJECTIVES:

  • Determine the safety of monoclonal antibody ABX-EGF in patients with renal, prostate, pancreatic, non-small cell lung, colorectal, esophageal, or gastroesophageal junction cancer.
  • Determine the pharmacokinetics and the dose-response relationship of this drug in this patient population.
  • Evaluate the clinical effect of this drug in this patient population.

OUTLINE: This is an open-label, dose-escalation, multicenter study.

Patients receive monoclonal antibody ABX-EGF IV over 1 hour once weekly on weeks 0-3* (enrollment for the weekly dosing schedule completed as of 4/21/03 [with the exception of patients undergoing full pharmacokinetic analyses, described below]) OR once every 2 weeks on weeks 0, 2, 4, and 6* OR once every 3 weeks on weeks 0, 3, 6, and 9*. Patients undergoing full pharmacokinetic analyses receive a loading dose on week 0 and the subsequent 3 doses on weeks 3-5.

NOTE: *All patients receive a total of 4 doses.

Cohorts of 2-8 patients receive escalating doses of monoclonal antibody ABX-EGF until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 or 3 patients experience dose-limiting toxicity.

Patients are followed every 2 weeks for 5 weeks.

PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study within approximately 14 months.

研究类型

介入性

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

    • California
      • Los Angeles、California、美国、90095-1738
        • Jonsson Comprehensive Cancer Center, UCLA
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19111
        • Fox Chase Cancer Center

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of 1 of the following:

    • Renal cell cancer (RCC)

      • Prior nephrectomy required
    • Prostate cancer

      • Failed prior primary therapy (e.g., surgery, radiotherapy, or chemotherapy)
      • Failed prior hormonal therapy (e.g., antiandrogen, luteinizing hormone-releasing hormone inhibitor, or orchiectomy)
    • Pancreatic cancer

      • Failed at least 1 prior standard therapy regimen for unresectable metastatic disease
    • Non-small cell lung cancer

      • Failed at least 1 prior standard therapy regimen for unresectable metastatic disease
    • Colorectal cancer

      • Received 1 or more prior chemotherapy regimen(s) for advanced metastatic disease
    • Esophageal cancer

      • Failed prior primary therapy (e.g., surgery, radiotherapy, or chemotherapy)
    • Gastroesophageal junction cancer
  • Evaluable disease
  • Epidermal growth factor receptor overexpression

    • Tumor tissue must yield the sum of 1+, 2+, or 3+ staining in at least 10% of evaluated tumor cells
  • No uncontrolled brain metastases
  • No evidence of disease progression or regression after a 30-day washout period

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100% OR
  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count greater than 1,000/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • AST/ALT no greater than 2 times upper limit of normal (ULN) (3 times ULN for liver metastases)
  • Alkaline phosphatase no greater than 2 times ULN (3 times ULN for liver metastases)

Renal:

  • Creatinine less than 2.2 mg/dL
  • NCI renal toxicity no greater than grade 2
  • No hypercalcemia (antihypercalcemic therapy allowed)

Cardiovascular:

  • Ejection fraction at least 45% by MUGA
  • No abnormal ECG or MUGA
  • No myocardial infarction within the past year

Pulmonary:

  • No abnormal chest x-ray
  • FEV_1 greater than 50% of predicted

Other:

  • No known allergy to ingredients of study drug
  • No known allergy to Staphylococcus aureus Protein A
  • HIV negative
  • No chronic medical or psychiatric condition that would preclude study compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 2 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 30 days since prior biologic therapy (e.g., antibodies, cytokines, or co-stimulatory pathway inhibitors)
  • No other concurrent biologic therapy

Chemotherapy:

  • See Disease Characteristics
  • At least 6 weeks since prior chemotherapy and recovered
  • No prior chemotherapy for RCC
  • No prior anthracyclines
  • No concurrent chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • Concurrent steroids allowed
  • Concurrent hormonal therapy allowed

Radiotherapy:

  • See Disease Characteristics
  • No prior mediastinal radiotherapy
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics
  • Recovered from any recent prior surgery

Other:

  • At least 30 days since prior investigational drug or device
  • At least 30 days since prior systemic therapy
  • No other concurrent investigational drugs
  • No other concurrent systemic agents or cancer therapy

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
  • 屏蔽:无(打开标签)

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。

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

2000年4月1日

初级完成 (实际的)

2005年7月1日

研究完成

2022年12月7日

研究注册日期

首次提交

2000年3月7日

首先提交符合 QC 标准的

2003年1月26日

首次发布 (估计)

2003年1月27日

研究记录更新

最后更新发布 (估计)

2013年1月8日

上次提交的符合 QC 标准的更新

2013年1月7日

最后验证

2013年1月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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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