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Celecoxib and Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer

2013年4月25日 更新者:Barbara Ann Karmanos Cancer Institute

Evaluation Of Celecoxib In Combination With Docetaxel In The Treatment Of Advanced Non-Small Cell Lung Cancer Patients Previously Treated With Platinum Based Chemotherapy

RATIONALE: Celecoxib may slow the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with celecoxib may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining celecoxib and docetaxel in treating patients who have advanced non-small cell lung cancer that has been previously treated with platinum-based chemotherapy.

研究概览

地位

完全的

条件

详细说明

OBJECTIVES:

  • Determine the efficacy and feasibility of celecoxib combined with docetaxel in patients with advanced non-small cell lung cancer previously treated with platinum-based chemotherapy.
  • Determine the response rate of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral celecoxib twice daily (beginning on day -7 of the first course) and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses after CR. Patients who achieve stable disease (SD) or a partial response (PR) receive a minimum of 2 additional courses after SD or PR. At the discretion of the treating physician, patients then receive maintenance therapy comprising celecoxib only.

Patients who discontinue therapy for disease progression or unacceptable toxicity are followed for at least 6 months.

PROJECTED ACCRUAL: A total of 21-39 patients will be accrued for this study within 13-28 months.

研究类型

介入性

注册 (实际的)

24

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

    • Michigan
      • Detroit、Michigan、美国、48201-1379
        • Barbara Ann Karmanos Cancer Institute

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

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS:

  • Diagnosis of stage IIIA, IIIB, or IV non-small cell lung cancer

    • Disease progression during or after 1 or more platinum-based chemotherapy regimens
  • Measurable or evaluable disease
  • No symptomatic or untreated brain or leptomeningeal metastases

    • Previously treated patients must be neurologically stable for 4 weeks after completion of appropriate therapy

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • SWOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 8 g/dL

Hepatic:

  • Bilirubin no greater than upper limit of normal (ULN)
  • AST/ALT no greater than ULN (or no greater than 2.5 times ULN if alkaline phosphatase no greater than ULN)
  • Alkaline phosphatase no greater than ULN (or no greater than 5 times ULN if AST/ALT no greater than ULN)
  • No history of chronic hepatitis of any duration

Renal:

  • Creatinine no greater than ULN

Cardiovascular:

  • No uncontrolled congestive heart failure
  • No uncontrolled angina
  • No myocardial infarction and/or stroke within the past 6 months
  • No active thromboembolic event within the past 4 weeks

Gastrointestinal:

  • No gastrointestinal bleeding within the past 6 months
  • No history of peptic ulcer disease

Other:

  • No prior hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • No prior allergy to any non-steroidal anti-inflammatory drug
  • No other prior or concurrent malignancy within the past 3 years except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
  • No grade 2 or greater peripheral neuropathy
  • No active infection
  • No other serious concurrent medical illness
  • No history of dementia, active psychiatric disorder, or other condition that would interfere with ability to take oral medication or preclude compliance with study
  • HIV negative
  • Must weigh at least 50 kg (110 pounds)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy
  • Prior paclitaxel allowed
  • No prior docetaxel

Endocrine therapy:

  • At least 3 days since prior steroids

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • No prior radiotherapy to target lesion

Surgery:

  • At least 4 weeks since prior major surgery

Other:

  • Prior intermittent use of non-steroidal anti-inflammatory drugs (NSAIDs), including rofecoxib or celecoxib, allowed
  • At least 1 week since prior fluconazole
  • No recent prior NSAIDs, including rofecoxib or celecoxib, for a duration of more than 30 consecutive days
  • No concurrent fluconazole or lithium
  • No other concurrent NSAIDs except aspirin administered at a dose of no more than 325 mg/day for cardiovascular conditions
  • No other concurrent cyclo-oxygenase-2 inhibitors
  • No other concurrent investigational agents

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:Celecoxib & Docetaxel

Celecoxib: 400mg by mouth, twice a day, each dose given with meals, to start -7 days prior to first cycle of treatment.

Doctaxel: Day 1, 75mg/m2 IV over 60 minutes, repeated every 21 days

400mg by mouth, twice a day, each dose given with meals, to start -7 days prior to first cycle of treatment.
其他名称:
  • 西乐葆
  • 庆祝
  • 温泉
On day 1, 75mg/m2 IV over 60 minutes, repeated every 21 days
其他名称:
  • 泰索帝

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
Efficacy of combining Celecoxib with Docetaxel
大体时间:Weeks 1 , 2 and 3
Blood levels of VEGF & PGE2
Weeks 1 , 2 and 3

次要结果测量

结果测量
措施说明
大体时间
Response rate of Celecoxib and Docetaxel
大体时间:Every 2 cycles (or every 42 days); After therapy is completed or if the patient is only on Celecoxib, will be assessed for progression every month by clinical exam and every 3 months by radiological evaluation.
CT Chest/Abdomen
Every 2 cycles (or every 42 days); After therapy is completed or if the patient is only on Celecoxib, will be assessed for progression every month by clinical exam and every 3 months by radiological evaluation.
Toxicity of Celecoxib and Docetaxel
大体时间:Every week
Routine bloodwork
Every week
Expression of cyclooxygenase-2 (COX-2) in tumors
大体时间:Pre-study
Tissue sample from initial diagnosis, parrafin embedded tissue block
Pre-study
Changes in plasma levels of prostaglandin E2 (PGE2) & vascular endthelial growth factor (VEGF)
大体时间:Pre-study; Weeks 1 , 2 and 3
Collecting blood plasma
Pre-study; Weeks 1 , 2 and 3
Vascular changes induced in the tumor by celecoxib
大体时间:Weeks 1, 3 & 6
Using DCE-MRI and PET scans to evaluate.
Weeks 1, 3 & 6

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。

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。

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

2001年10月1日

初级完成 (实际的)

2004年5月1日

研究完成 (实际的)

2008年2月1日

研究注册日期

首次提交

2002年2月14日

首先提交符合 QC 标准的

2003年10月20日

首次发布 (估计)

2003年10月21日

研究记录更新

最后更新发布 (估计)

2013年4月29日

上次提交的符合 QC 标准的更新

2013年4月25日

最后验证

2013年4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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