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Celecoxib, Fluorouracil, and Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer That Can Be Removed By Surgery

2013年3月2日 更新者：A Bapsi Chakravarthy, MD、Vanderbilt-Ingram Cancer Center

Phase II Pilot Study of Pre-Operative Celecoxib (Celebrex) in Combination With Prolonged Venous Infusion 5FU and Radiation Therapy for Patients With Stage II/III Resectable Rectal Cancer

RATIONALE: Celecoxib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Celecoxib may make tumor cells more sensitive to radiation therapy. Giving celecoxib together with fluorouracil and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving celecoxib together with fluorouracil and radiation therapy works in treating patients with stage II or stage III rectal cancer that can be removed by surgery.

研究概览

地位

完全的

条件

干预/治疗

详细说明

OBJECTIVES:

  • Determine cyclo-oxygenase-2 (COX-2) overexpression in patients with resectable stage II or III rectal cancer treated with neoadjuvant celecoxib, fluorouracil, and radiotherapy.
  • Determine whether administration of celecoxib, a COX-2 inhibitor, results in changes in tumor (COX-2 overexpressing) levels of eicosanoids but not in the surrounding normal tissue.
  • Determine if there is a greater change in protein and gene expression in post-treatment biopsies when compared to pretreatment biopsies that are greater for tumor (COX-2 overexpression) than in surrounding normal tissue.
  • Determine whether patients who express the greatest degree of change in gene and protein expression are those most likely to respond to therapy.
  • Assess the toxicities of concurrent treatment with celecoxib, fluorouracil, and radiotherapy.

OUTLINE: This is a pilot study.

Patients receive oral celecoxib twice daily beginning 5 days prior to radiotherapy and continuing until completion of radiotherapy. Patients undergo radiotherapy 5 days a week for 5 weeks. Patients also receive concurrent fluorouracil IV continuously for 5 weeks. Patients undergo radical resection 4-10 weeks after completion of chemoradiotherapy.

Patients undergo tumor biopsy at baseline and then at the time of surgical resection. Patients also undergo blood and urine collection at baseline, 5 days after initiation of celecoxib, 7 days after initiation of celecoxib in combination with fluorouracil and radiotherapy, and at the time of surgical resection. The specimens are evaluated for COX-2 expression, eicosanoid production, and gene and protein expression using immunohistochemistry, microarray, and mass spectrometry.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 28 patients will be accrued for this study.

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

  • 美国
    • Tennessee
      • Nashville、Tennessee、美国、37212
        • Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
      • Nashville、Tennessee、美国、37232-5671
        • Vanderbilt-Ingram 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 primary adenocarcinoma of the rectum

    • Stage II or III disease

  • Distal border of tumor must be at or below the peritoneal reflection

    • Distal border of the tumor must be within 12 cm of the anal verge by proctoscopic exam
  • Tumor must be clinically resectable
  • Transmural penetration beyond muscularis propria by transrectal ultrasound
  • No high-grade obstruction
  • No evidence of metastatic disease

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • WBC ≥ 4,000/mm³
  • Platelet count ≥ 150,000/mm³
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other serious medical illness or psychiatric condition that would preclude study treatment
  • No history of allergy to celecoxib or any other NSAIDs
  • No history of allergy to sulfonamides
  • No prior or concurrent malignancy except inactive noninvasive cervical carcinoma or skin cancer (excluding melanoma) or other cancer that has been disease free for ≥ 5 years

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy to the pelvis
  • At least 7 days since prior and no other concurrent COX-2 inhibitors or nonsteroidal anti-inflammatory drugs (NSAIDs)
  • No concurrent warfarin except low-dose warfarin (1 mg/day)

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：treatment intervention
药品：celecoxib
twice daily beginning 5 days prior to radiotherapy and continuing until completion of radiotherapy
药品：fluorouracil
Patients receive concurrent fluorouracil IV continuously for 5 weeks.
程序：conventional surgery
4-10 weeks after completion of chemoradiotherapy
辐射：radiation therapy
Patients undergo radiotherapy 5 days a week for 5 weeks
程序：tumor biopsy
at baseline and then at the time of surgical resection
其他：laboratory biomarker analysis
blood and urine collected at baseline, 5 days after initiation of celecoxib, 7 days after initiation of celecoxib in combination with fluorouracil and radiotherapy, and at the time of surgical resection. specimens are evaluated for COX-2 expression, eicosanoid production, and gene and protein expression using immunohistochemistry, microarray, and mass spectrometry.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Pathologic complete response rate
大体时间：at time of surgery, day 5
at time of surgery, day 5

次要结果测量

结果测量
大体时间
Complete resection rate
大体时间：at time of surgery, day 5
at time of surgery, day 5
Patterns of failure
大体时间：during study, beginning day 5 forward
during study, beginning day 5 forward
Survival
大体时间：at time of death
at time of death
Toxicity
大体时间：5 days before surgery & 5 days after surgery
5 days before surgery & 5 days after surgery

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

Vanderbilt-Ingram Cancer Center

合作者

National Cancer Institute (NCI)

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7月1日

初级完成 (实际的)

2004年11月1日

研究完成 (实际的)

2008年3月1日

研究注册日期

首次提交

2006年6月13日

首先提交符合 QC 标准的

2006年6月13日

首次发布 (估计)

2006年6月15日

研究记录更新

最后更新发布 (估计)

2013年3月5日

上次提交的符合 QC 标准的更新

2013年3月2日

最后验证

2013年3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

  • VICC GI 0173
  • P30CA068485 (美国 NIH 拨款/合同)
  • P50CA095103 (美国 NIH 拨款/合同)
  • VICC-GI-0173
  • VICC-020031

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.

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Switzerland

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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