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Celecoxib in Treating Patients With Early-Stage Head and Neck Cancer or Non-Small Cell Lung Cancer

2012年6月7日 更新者:Northwestern University

Pilot Randomized Trial Of Adjuvant Celecoxib In Patients With Early Stage Head And Neck And Non-Small Cell Lung Cancers

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be an effective way to prevent the recurrence of stage I or stage II head and neck cancer or stage I non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying celecoxib to see how well it works compared to that of a placebo in preventing disease recurrence in patients with stage I or stage II head and neck cancer or stage I non-small cell lung cancer.

研究概览

详细说明

OBJECTIVES:

  • Compare the rate of new malignancies (recurrences and second primary tumors) in patients with early-stage head and neck cancer or non-small cell lung cancer treated with celecoxib vs placebo.
  • Compare the event-free and overall survival of patients treated with this drug vs placebo.
  • Determine the toxic effects associated with long-term use of celecoxib in these patients.
  • Correlate cyclooxygenase-2 and transforming growth factor (TGF)-beta expression and CYP2C9 and TGF-beta genotypes with the rate of new malignancies and survival of patients treated with this drug vs placebo.

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to smoking history (active smokers [including those who quit within 1 year of diagnosis] vs former smokers vs non-smokers), tumor type (lung cancer vs head and neck cancer), and stage (I vs II for head and neck cancer or T1 vs T2 for lung cancer). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral celecoxib twice daily.
  • Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 24 months in the absence of disease recurrence or unacceptable toxicity.

Patients are followed every 6 months for 5 years or until disease recurrence.

PROJECTED ACCRUAL: A total of 121 patients (approximately 60 per treatment arm) will be accrued for this study.

研究类型

介入性

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

    • Illinois
      • Chicago、Illinois、美国、60637-1470
        • University of Chicago Cancer Research Center
      • Chicago、Illinois、美国、60611-3013
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
      • Chicago、Illinois、美国、60612
        • Rush Cancer Institute at Rush University Medical Center
    • North Carolina
      • Chapel Hill、North Carolina、美国、27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

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:

  • One of the following histologically confirmed diagnoses:

    • Stage I non-small cell lung cancer (NSCLC)

      • No small cell component
    • Stage I-II squamous cell cancer of the head and neck

      • No WHO type II or III nasopharyngeal cancer
      • No sinonasal undifferentiated carcinoma
  • No evidence of disease
  • Must have undergone surgery or radiotherapy with curative intent within the past 4-24 weeks

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Platelet count at least 50,000/mm^3

Hepatic

  • Bilirubin normal
  • AST/ALT no greater than 2 times upper limit of normal

Renal

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular

  • No uncontrolled hypertension
  • No severe congestive heart failure

Pulmonary

  • No history of asthma caused by cyclooxygenase-2 (COX-2) inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, or sulfonamides

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No other prior malignancy (including skin cancer and in situ malignancies)
  • No diagnosis of peptic ulcer disease or gastritis/esophagitis within the past 60 days
  • No prior hypersensitivity reaction to COX-2 inhibitors, NSAIDs, salicylates, or sulfonamides
  • No other concurrent medical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • No cumulative oral or IV corticosteroid use totalling more than 2 weeks within the past 3 months
  • No concurrent oral steroids for more than 2 consecutive weeks
  • Concurrent inhaled steroids allowed

Radiotherapy

  • See Disease Characteristics
  • No prior definitive radiotherapy for stage I NSCLC

Surgery

  • See Disease Characteristics
  • Prior pneumonectomy or lobectomy with mediastinal lymph node sampling or dissection for stage I NSCLC allowed
  • No prior segmentectomies or wedge resections for stage I NSCLC

Other

  • More than 60 days since prior treatment for peptic ulcer disease or gastritis/esophagitis
  • No prior NSAID use within the past 30 days at a frequency of 3 or more times a week for more than 2 weeks
  • No concurrent NSAIDs (including low-dose aspirin)
  • No other concurrent COX-2 inhibitors
  • No concurrent fluconazole
  • No concurrent lithium

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:随机化
  • 屏蔽:双倍的

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。

调查人员

  • 学习椅:Athanassios Argiris, MD、Robert H. Lurie Cancer Center

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

2002年9月1日

初级完成 (实际的)

2006年12月1日

研究完成 (实际的)

2006年12月1日

研究注册日期

首次提交

2003年4月7日

首先提交符合 QC 标准的

2003年4月8日

首次发布 (估计)

2003年4月9日

研究记录更新

最后更新发布 (估计)

2012年6月11日

上次提交的符合 QC 标准的更新

2012年6月7日

最后验证

2012年6月1日

更多信息

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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