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Gemcitabine With or Without Dalteparin in Treating Patients With Unresectable or Metastatic Pancreatic Cancer

2015年10月13日 更新者:Gary Morrow

A Prospective Randomized Controlled Multicenter Study of the Effect of Dalteparin on Quality of Life in Unresectable Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Anticoagulants such as dalteparin may help prevent blood clots in patients being treated with gemcitabine for unresectable or metastatic pancreatic cancer.

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

研究概览

详细说明

OBJECTIVES:

  • Compare the quality of life of patients with unresectable or metastatic pancreatic cancer treated with gemcitabine with or without dalteparin.
  • Compare the survival of patients treated with these regimens.
  • Compare the incidence of venous thromboembolic complications in patients treated with these regimens.
  • Determine the safety of dalteparin, in terms of bleeding complications, in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (unresectable nonmetastatic vs metastatic). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 for the first course only. Beginning on week 9, patients receive gemcitabine IV over 30 minutes once weekly for 3 weeks. Treatment then repeats every 4 weeks for up to 6 months in the absence of unacceptable toxicity or disease progression.
  • Arm II: Patients receive gemcitabine as in arm I and dalteparin subcutaneously once daily for 6 months in the absence of unacceptable toxicity.

Quality of life is assessed at baseline and every 4 weeks during study therapy.

Patients are followed every 4 weeks.

PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 40 months.

研究类型

介入性

注册 (预期的)

400

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

    • Alabama
      • Mobile、Alabama、美国、36607
        • MBCCOP - Gulf Coast
    • Colorado
      • Denver、Colorado、美国、80224
        • CCOP - Colorado Cancer Research Program, Incorporated
    • Illinois
      • Chicago、Illinois、美国、60612-7323
        • MBCCOP - University of Illinois at Chicago
      • Decatur、Illinois、美国、62526
        • CCOP - Central Illinois
    • Michigan
      • Kalamazoo、Michigan、美国、49007-3731
        • CCOP - Kalamazoo
    • Missouri
      • Kansas City、Missouri、美国、64131
        • CCOP - Kansas City
    • New York
      • East Syracuse、New York、美国、13057
        • CCOP - Hematology-Oncology Associates of Central New York
      • Rochester、New York、美国、14642
        • University of Rochester Cancer Center CCOP Research Base
    • North Carolina
      • Goldsboro、North Carolina、美国、27534-9479
        • CCOP - Southeast Cancer Control Consortium
    • Ohio
      • Columbus、Ohio、美国、43215
        • CCOP - Columbus
      • Dayton、Ohio、美国、45429
        • CCOP - Dayton
    • South Carolina
      • Greenville、South Carolina、美国、29615
        • CCOP - Greenville
    • Washington
      • Tacoma、Washington、美国、98405-0986
        • CCOP - Northwest

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 至 120年 (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:

  • Histologically or cytologically confirmed pancreatic adenocarcinoma or poorly differentiated carcinoma of the pancreas that is considered ineligible for curative resection

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Eastern Cooperative Oncology Group 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • White Blood Cell count greater than 3,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • No clinically significant bleeding disorder
  • No prior heparin-induced thrombocytopenia

Hepatic:

  • Bilirubin less than 2.0 mg/dL
  • aspartate aminotransferase less than 3 times normal

Renal:

  • Creatinine less than 2.0 mg/dL

Cardiovascular:

  • No prior hemorrhagic stroke
  • No uncontrolled hypertension (sustained blood pressure greater than 200 mm Hg systolic or 110 mm Hg diastolic)

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other active malignancy
  • No gastrointestinal bleeding within the past 30 days
  • No contraindications to anticoagulation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy for metastatic disease
  • Prior adjuvant chemotherapy allowed

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy and recovered

Surgery:

  • Prior surgical resection allowed
  • At least 4 weeks since prior surgery with non-curative intent and recovered
  • More than 30 days since prior neurologic or ophthalmologic surgery

Other:

  • At least 2 weeks since prior low-molecular-weight heparin
  • More than 30 days since prior experimental therapeutic agent
  • No concurrent heparin or warfarin for pre-existing condition

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:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Dalteparin
5,000 anti-Xa units of dalteparin subcutaneously once daily for six months in addition to gemcitabine at 1,000 mg/m2 as a 30-minute infusion weekly for 7 weeks followed by a week of rest for the first cycle and weekly for three weeks followed by a week of rest for each subsequent cycle.

研究衡量的是什么?

主要结果指标

结果测量
Quality of life as measured by FACT-Hep version 4 every 4 weeks

次要结果测量

结果测量
生存
Frequency of symptomatic venous thromboembolic complications
Safety as measured by the occurrence of bleeding complications

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

调查人员

  • 学习椅:Kishan J. Pandya, MD、University of Rochester

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10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

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)

2015年10月14日

上次提交的符合 QC 标准的更新

2015年10月13日

最后验证

2015年10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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