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Paclitaxel and Carboplatin With or Without Celecoxib Before Surgery in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer

2020年7月30日 更新者:Jonsson Comprehensive Cancer Center

A Randomized Double Blind Phase II Study of Preoperative Celecoxib/Paclitaxel/Carboplatin for Stage IIIA Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy such as paclitaxel and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug, may stop the growth of tumor cells by stopping blood flow to the tumor, and/or may block the enzymes necessary for tumor cell growth. Giving combination chemotherapy with celecoxib before surgery may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying how well giving paclitaxel together with carboplatin followed by surgery works compared to giving paclitaxel together with carboplatin and celecoxib followed by surgery in treating patients with stage IIIA non-small cell lung cancer.

研究概览

详细说明

OBJECTIVES:

  • Compare the complete pathological response rate and/or minimal residual microscopic disease in patients with stage IIIA non-small cell lung cancer treated with preoperative paclitaxel and carboplatin with vs without celecoxib.
  • Compare the clinical response rate in patients treated with these regimens.
  • Compare chemotherapy-related toxicity in patients treated with these regimens.
  • Compare the time to progression, disease-free survival, and overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to use of aspirin for prior cardiovascular disease (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on days 1, 22, and 43. Patients also receive oral celecoxib twice daily beginning on day 1 and continuing until the morning of surgical resection.
  • Arm II: Patients receive paclitaxel and carboplatin as in arm I and an oral placebo twice daily beginning on day 1 and continuing until the morning of surgical resection.

In both arms, patients undergo surgical resection and complete mediastinal lymph node dissection within 3-6 weeks after completion of chemotherapy. Patients resume oral celecoxib or placebo twice daily within 28-42 days after surgery and continue until 3 years from the date of randomization in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3-6 months.

PROJECTED ACCRUAL: A total of 110 patients (55 per treatment arm) will be accrued for this study.

研究类型

介入性

注册 (实际的)

7

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

    • California
      • Los Angeles、California、美国、90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA
    • New York
      • New York、New York、美国、10021
        • New York Weill Cornell Cancer Center at Cornell University

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

Inclusion Criteria:

  • Patients with biopsy proven non-small cell lung cancer clinical stage IIIA
  • Mediastinoscopy positive N2 disease is mandatory
  • The disease must be deemed potentially resectable by the thoracic surgeon
  • Karnofsky performance status > 80%
  • Pulmonary function must be acceptable for surgery according to institutional standards
  • Acceptable hepatic, renal and bone marrow function

    • Total serum bilirubin < ULN
    • AST and/or ALT < 2.5x ULN
    • Alkaline phosphatase < 2.5x ULN
    • Serum creatinine < 2.0 mg/mm3
    • White blood cell > 3000/mm3
    • Platelets > 100,000/mm3
  • Age 18 or older
  • Willingness to abstain from chronic use of NSAIDs (defined as > 7 days of continuous therapy per month OR defined as frequency of > 3 times per week) for the duration of the study. For those patients on NSAIDs prior to study entry, cessation of the drug for 72 hours prior to study entry is required
  • Patients on low-dose ASA (<325 mg daily) for prophylaxis of cardiovascular disease prior to study entry may remain on that dose of ASA during this trial
  • No anticipated chronic use of steroids. Patients may take the inhaled steroids mometasone or fluticasone if medically indicated

Exclusion Criteria:

  • Patients with known hypersensitivity or allergic reactions to COX-2 inhibitors, sulfonamides, NSAIDs, or salicylates
  • Hypersensitivity to paclitaxel
  • Significant medical or psychiatric illness that would interfere with patient compliance
  • Prior malignancy within the last 3 years with the exception of non-melanoma skin cancer
  • Receiving other investigational agents during the course of this study or are < 3 weeks from completion of other clinical trial therapy
  • Patients with a history of peptic ulcer disease, bleed disorder, irritable bowel disease, inflammatory bowel syndrome, chronic diarrhea or bowel obstruction within 5 years
  • Patients receiving enzyme-inducing anticonvulsants are ineligible. Patients who require concomitant therapy with NSAIDs or COX-2 inhibitors
  • Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment
  • Patients receiving lithium or fluconazole
  • Pregnant women or women of childbearing potential that refuse to use effective contraception during the period of chemotherapy.
  • Patients with a significant history of unstable cardiovascular disease
  • Uncontrolled diabetes mellitus or uncontrolled infection, including HIV or interstitial pneumonia or interstitial fibrosis

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
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:paclitaxel/carboplatin/celecoxib
Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion Carboplatin: dosed at an AUC of 6 by the Calvert Formula Celecoxib: 400 mg po BID 3 cycles of paclitaxel and carboplatin 21 days apart celecoxib 3-7 days before first dose of chemotherapy
Carboplatin: dosed at an AUC of 6 by the Calvert Formula 3 cycles of carboplatin 21 days apart
Celecoxib: 400 mg po BID celecoxib 3-7 days before first dose of chemotherapy
Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion 3 cycles of paclitaxel 21 days apart
安慰剂比较:paclitaxel/Carboplatin/Placebo
Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion Carboplatin: dosed at an AUC of 6 by the Calvert Formula Placebo 3 cycles of paclitaxel and carboplatin 21 days apart Placebo 3-7 days before first dose of chemotherapy
Carboplatin: dosed at an AUC of 6 by the Calvert Formula 3 cycles of carboplatin 21 days apart
Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion 3 cycles of paclitaxel 21 days apart
placebo 3-7 days before first dose of chemotherapy

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Rates of complete pathological response and/or minimal residual microscopic disease at 3 years
大体时间:3 years
3 years

次要结果测量

结果测量
大体时间
Clinical response at 3 years
大体时间:3 years
3 years
Difference in time to progression, disease-free survival, and overall survival between Arm I and Arm II at 3 years
大体时间:3 years
3 years
Toxicity in patients with paclitaxel/carboplatin/celecoxib vs. paclitaxel/carboplatin/placebo

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。

合作者

调查人员

  • 首席研究员:Karen Rickard、City of Hope Comprehensive 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

2003年3月1日

初级完成 (实际的)

2006年11月1日

研究完成 (实际的)

2006年11月1日

研究注册日期

首次提交

2003年6月5日

首先提交符合 QC 标准的

2003年6月5日

首次发布 (估计)

2003年6月6日

研究记录更新

最后更新发布 (实际的)

2020年8月3日

上次提交的符合 QC 标准的更新

2020年7月30日

最后验证

2012年8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

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

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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