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Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

2013年6月25日 更新者：Cancer Research UK

A Phase III Multicenter Randomized Clinical Trial Comparing Gemcitabine Alone Or In Combination With Capecitabine For The Treatment Of Patients With Advanced Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if gemcitabine is more effective with or without capecitabine in treating pancreatic cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or without capecitabine in treating patients who have locally advanced or metastatic pancreatic cancer.

研究概览

地位

完全的

条件

干预/治疗

详细说明

OBJECTIVES:

  • Compare the 1-year survival rate of patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine with or without capecitabine.
  • Compare the median and 2-year survival rates and the objective response rates of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is an randomized, open-label, multicenter study. Patients are stratified according to disease stage (locally advanced vs metastatic) and performance status (0 and 1 vs 2). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43 during the first course. After a 1-week rest period, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Subsequent courses repeat every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 3 months for 1 year, and then annually thereafter.

Patients are followed every 3 months.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 508 patients (254 per treatment arm) will be accrued for this study.

研究类型

介入性

注册 (预期的)

508

阶段

  • 第三阶段

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

  • 英国
    • England
      • Bath、England、英国、BA1 3NG
        • Royal United Hospital
      • Bournemouth、England、英国、BH7 7DW
        • Royal Bournemouth Hospital
      • Bristol、England、英国、BS2 8ED
        • Bristol Haematology and Oncology centre
      • Cambridge、England、英国、CB2 2QQ
        • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
      • Derby、England、英国、DE1 2QY
        • Derbyshire Royal Infirmary
      • Exeter、England、英国、EX2 5DW
        • Royal Devon and Exeter Hospital
      • Ipswich、England、英国、IP4 5PD
        • Ipswich Hospital NHS Trust
      • King's Lynn、England、英国、PE30 4ET
        • Queen Elizabeth Hospital
      • Leeds、England、英国、LS16 6QB
        • Cookridge Hospital at Leeds Teaching Hospital NHS Trust
      • Leicester、England、英国、LE1 5WW
        • Leicester Royal Infirmary
      • Lincoln、England、英国、LN2 5QY
        • Lincoln County Hospital
      • Liverpool、England、英国、L69 3GA
        • Royal Liverpool University Hospital
      • Liverpool、England、英国、L3 9TA
        • Cancer Research UK Liverpool Cancer Trials Unit
      • London、England、英国、SE1 7EH
        • St. Thomas' Hospital
      • Manchester、England、英国、M20 4BX
        • Christie Hospital NHS Trust
      • Merseyside、England、英国、CH63 4JY
        • Clatterbridge Centre for Oncology NHS Trust
      • Middlesbrough, Cleveland、England、英国、TS4 3BW
        • James Cook University Hospital at South Tees Hospitals NHS Trust
      • Newcastle-Upon-Tyne、England、英国、NE4 6BE
        • Northern Centre for Cancer Treatment at Newcastle General Hospital
      • Norwich、England、英国、NR4 7UY
        • Norfolk and Norwich University Hospital
      • Plymouth、England、英国、PL6 8DH
        • Derriford Hospital
      • Poole Dorset、England、英国、BH15 2JB
        • Poole Hospital NHS Trust
      • Prescot Merseyside、England、英国、L35 5DR
        • Whiston Hospital
      • Preston、England、英国、PR2 9HT
        • Royal Preston Hospital
      • Salisbury、England、英国、SP2 8BJ
        • Salisbury District Hospital
      • Southampton、England、英国、SO14 0YG
        • Royal South Hants Hospital
      • Stoke-On-Trent、England、英国、ST4 7LN
        • University Hospital of North Staffordshire
      • Sutton、England、英国、SM2 5PT
        • Royal Marsden NHS Foundation Trust - Surrey
      • Warrington、England、英国、WA5 1QG
        • Warrington Hospital NHS Trust
    • Scotland
      • Aberdeen、Scotland、英国、AB25 2ZN
        • Aberdeen Royal Infirmary
    • Wales
      • Swansea、Wales、英国、SA2 8QA
        • Singleton Hospital of the Swansea NHS Trust

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 or cytologically confirmed ductal adenocarcinoma of the pancreas

    • Locally advanced or metastatic disease not amenable to curative surgical resection
    • Macroscopic residual disease after prior resection with histological confirmation is allowed
  • Unidimensionally measurable disease
  • No intracerebral metastases or meningeal carcinomatosis

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • WHO 0-2

Life expectancy:

  • More than 3 months

Hematopoietic:

  • WBC greater than 3,000/mm3
  • Neutrophil count greater than 1,500/mm3
  • Platelet count greater than 100,000/mm3

Hepatic:

  • Bilirubin less than 2 mg/dL

Renal:

  • Creatinine less than 2 mg/dL
  • Creatinine clearance greater than 50 mL/min

Cardiovascular:

  • No New York Heart Association class III or IV heart disease
  • No uncontrolled angina pectoris

Other:

  • No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No other concurrent uncontrolled medical condition
  • No other medical or psychiatric condition that would preclude study
  • No known hypersensitivity to fluorouracil
  • No dihydropyrimidine dehydrogenase deficiency
  • No known malabsorption syndromes
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy (including preoperative or adjuvant) for this disease
  • No other concurrent cytotoxic chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy (including preoperative or adjuvant) for this disease

Surgery:

  • See Disease Characteristics

Other:

  • No prior investigational drugs (including preoperative or adjuvant) for this disease
  • No other concurrent investigational drugs
  • No concurrent dipyridamole or allopurinol
  • No concurrent sorivudine or sorivudine analogs (e.g., brivudine) (capecitabine arm only)

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：无（打开标签）

研究衡量的是什么？

主要结果指标

结果测量
1 年生存

次要结果测量

结果测量
毒性
生活质量
客观反应率
Median survival rate
Survival rate at 2 years

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

Cancer Research UK

调查人员

  • Emily Owen、Cancer Research UK

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。

一般刊物

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4月1日

研究完成 (实际的)

2007年5月1日

研究注册日期

首次提交

2002年3月8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6月26日

上次提交的符合 QC 标准的更新

2013年6月25日

最后验证

2007年4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

  • CRUK-GEM-CAP
  • CDR0000069263 (注册表标识符：PDQ (Physician Data Query))
  • EU-20116
  • ISRCTN11513444

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.

盐酸吉西他滨的临床试验

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 Panama

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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