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Docetaxel in Treating Patients With Recurrent or Persistent Endometrial Carcinoma (Cancer)

2014年1月10日 更新者：Gynecologic Oncology Group

A Phase II Evaluation of Weekly Docetaxel (NSC #628503) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with recurrent or persistent endometrial carcinoma (cancer).

研究概览

地位

完全的

条件

干预/治疗

详细说明

OBJECTIVES:

  • Determine the antitumor activity of docetaxel in patients with recurrent or persistent endometrial carcinoma.
  • Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 10-18 months.

研究类型

介入性

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

  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2N 4N2
        • Tom Baker Cancer Centre - Calgary
  • 挪威
      • Oslo、挪威、N-0310
        • Norwegian Radium Hospital
  • 日本
      • Kagoshima City、日本、892-8580
        • Kagoshima City Hospital
  • 澳大利亚
    • New South Wales
      • Camperdown、New South Wales、澳大利亚、1450
        • Australia New Zealand Gynaecological Oncology Trials Group
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35294-3300
        • Comprehensive Cancer Center at University of Alabama at Birmingham
    • Arizona
      • Phoenix、Arizona、美国、85006-2726
        • CCOP - Western Regional, Arizona
    • California
      • Los Angeles、California、美国、90095-1740
        • Jonsson Comprehensive Cancer Center at UCLA
      • Los Gatos、California、美国、95032
        • Women's Cancer Center - Los Gatos
      • Orange、California、美国、92868
        • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
    • Colorado
      • Denver、Colorado、美国、80010
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center
    • Connecticut
      • New Haven、Connecticut、美国、06520-8028
        • Yale Comprehensive Cancer Center
    • Delaware
      • Newark、Delaware、美国、19713
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington、District of Columbia、美国、20307-5001
        • Walter Reed Army Medical Center
    • Florida
      • Tampa、Florida、美国、33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
    • Hawaii
      • Honolulu、Hawaii、美国、96813
        • MBCCOP - Hawaii
    • Illinois
      • Chicago、Illinois、美国、60637-1470
        • University of Chicago Cancer Research Center
      • Chicago、Illinois、美国、60612
        • MBCCOP - University of Illinois at Chicago
      • Chicago、Illinois、美国、60612-3824
        • Rush University Medical Center
      • Decatur、Illinois、美国、62794-9640
        • CCOP - Central Illinois
      • Evanston、Illinois、美国、60201
        • CCOP - Evanston
      • Urbana、Illinois、美国、61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Indianapolis、Indiana、美国、46202-5289
        • Indiana University Cancer Center
      • South Bend、Indiana、美国、46617
        • Saint Joseph Regional Medical Center
    • Iowa
      • Iowa City、Iowa、美国、52242-1002
        • Holden Comprehensive Cancer Center at University of Iowa
    • Kentucky
      • Lexington、Kentucky、美国、40536-0084
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
    • Massachusetts
      • Boston、Massachusetts、美国、02111
        • Cancer Center at Tufts - New England Medical Center
      • Worcester、Massachusetts、美国、01605-2982
        • UMASS Memorial Cancer Center - University Campus
    • Michigan
      • Ann Arbor、Michigan、美国、48106
        • CCOP - Michigan Cancer Research Consortium
      • Grand Rapids、Michigan、美国、49503
        • CCOP - Grand Rapids
      • Kalamazoo、Michigan、美国、49007-3731
        • CCOP - Kalamazoo
    • Minnesota
      • Minneapolis、Minnesota、美国、55455
        • University of Minnesota Cancer Center
      • Rochester、Minnesota、美国、55905-0001
        • Mayo Clinic Cancer Center
      • Saint Louis Park、Minnesota、美国、55416
        • CCOP - Metro-Minnesota
    • Mississippi
      • Jackson、Mississippi、美国、39216-4505
        • University of Mississippi Medical Center
      • Keesler AFB、Mississippi、美国、39534-2576
        • Keesler Medical Center - Keesler Air Force Base
    • Missouri
      • Columbia、Missouri、美国、65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Kansas City、Missouri、美国、64131
        • CCOP - Kansas City
      • Saint Louis、Missouri、美国、63110
        • Siteman Cancer Center at Barnes-Jewish Hospital
      • Springfield、Missouri、美国、65807
        • CCOP - Cancer Research for the Ozarks
    • Nebraska
      • Omaha、Nebraska、美国、68106
        • CCOP - Missouri Valley Cancer Consortium
    • New Jersey
      • Camden、New Jersey、美国、08103-1489
        • Cancer Institute of New Jersey at the Cooper University Hospital
    • New York
      • Brooklyn、New York、美国、11203
        • SUNY Downstate Medical Center
      • Buffalo、New York、美国、14263-0001
        • Roswell Park Cancer Institute
      • Manhasset、New York、美国、11030
        • North Shore University Hospital
      • New York、New York、美国、10021
        • Memorial Sloan-Kettering Cancer Center
      • Stony Brook、New York、美国、11790-7775
        • Long Island Cancer Center at Stony Brook University Hospital
    • North Carolina
      • Chapel Hill、North Carolina、美国、27599-7570
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Durham、North Carolina、美国、27710
        • Duke Comprehensive Cancer Center
      • Greenville、North Carolina、美国、27858
        • Gynecologic Oncology Network
      • Winston-Salem、North Carolina、美国、27157-1065
        • Comprehensive Cancer Center at Wake Forest University
    • Ohio
      • Cincinnati、Ohio、美国、45267-0520
        • Charles M. Barrett Cancer Center at University Hospital
      • Cleveland、Ohio、美国、44124
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland、Ohio、美国、44106
        • Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
      • Columbus、Ohio、美国、43210-1240
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73104
        • University of Oklahoma College of Medicine
    • Oregon
      • Portland、Oregon、美国、97225
        • CCOP - Columbia River Oncology Program
    • Pennsylvania
      • Abington、Pennsylvania、美国、19001-3788
        • Abington Memorial Hospital
      • Danville、Pennsylvania、美国、17822-2001
        • CCOP - Geisinger Clinic and Medical Center
      • Hershey、Pennsylvania、美国、17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Philadelphia、Pennsylvania、美国、19111
        • Fox Chase Cancer Center
      • Philadelphia、Pennsylvania、美国、19104-4283
        • Abramson Cancer Center of the University of Pennsylvania
      • Philadelphia、Pennsylvania、美国、19107
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
      • Pittsburgh、Pennsylvania、美国、15213-3180
        • UPMC Cancer Center at Magee-Womens Hospital
    • Tennessee
      • Knoxville、Tennessee、美国、37917
        • Southeast Gynecologic Oncology Associates
      • Nashville、Tennessee、美国、37232-2516
        • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
    • Texas
      • Dallas、Texas、美国、75390-9032
        • Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
      • Galveston、Texas、美国、77555-0587
        • University of Texas Medical Branch
      • Houston、Texas、美国、77030-4009
        • MD Anderson Cancer Center at University of Texas
      • Temple、Texas、美国、76508
        • CCOP - Scott and White Hospital
    • Vermont
      • Burlington、Vermont、美国、05401
        • Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus
    • Virginia
      • Charlottesville、Virginia、美国、22908
        • Cancer Center at the University of Virginia
    • Washington
      • Seattle、Washington、美国、98109-1024
        • Fred Hutchinson Cancer Research Center
      • Tacoma、Washington、美国、98405
        • MultiCare Regional Cancer Center at Tacoma General Hospital
    • Wisconsin
      • Madison、Wisconsin、美国、53792-6188
        • University of Wisconsin Comprehensive Cancer Center
      • Marshfield、Wisconsin、美国、54449
        • CCOP - Marshfield Clinic Research Foundation

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

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

女性

描述

DISEASE CHARACTERISTICS:

  • Histologically confirmed endometrial carcinoma

    • Recurrent or persistent disease
    • Refractory to curative or standard therapy

  • Measurable disease

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

    • At least 1 target lesion

      • Tumors within a previously irradiated field are not considered target lesions

  • Received 1 prior chemotherapy regimen for endometrial carcinoma, including high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment

    • One additional non-cytotoxic regimen for recurrent or persistent disease allowed, including monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction
  • Ineligible for a higher priority GOG protocol

PATIENT CHARACTERISTICS:

Age

  • Any age

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • SGOT ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Bilirubin ≤ 1.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No neuropathy (sensory and motor) ≥ grade 2
  • No active infection requiring antibiotics
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • At least 3 weeks since prior biologic or immunologic therapy for malignant tumor
  • No concurrent prophylactic growth factors
  • No concurrent prophylactic thrombopoietic agents

Chemotherapy

  • See Disease Characteristics
  • Recovered from prior chemotherapy
  • No more than 1 prior cytotoxic chemotherapy regimen (single or combination cytotoxic drugs)

Endocrine therapy

  • At least 1 week since prior hormonal therapy for malignant tumor
  • Concurrent hormone replacement therapy allowed

Radiotherapy

  • See Disease Characteristics
  • Recovered from prior radiotherapy

Surgery

  • Recovered from prior surgery

Other

  • At least 3 weeks since other prior therapy for malignant tumor
  • No prior anticancer therapy that would preclude current protocol therapy
  • No concurrent amifostine or other protective reagents

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
  • 屏蔽：无（打开标签）

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

Gynecologic Oncology Group

合作者

National Cancer Institute (NCI)

调查人员

  • 学习椅：Agustin Garcia, MD、Premiere Oncology

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

2004年7月1日

初级完成 (实际的)

2005年12月1日

研究注册日期

首次提交

2004年6月10日

首先提交符合 QC 标准的

2004年6月10日

首次发布 (估计)

2004年6月11日

研究记录更新

最后更新发布 (估计)

2014年1月13日

上次提交的符合 QC 标准的更新

2014年1月10日

最后验证

2014年1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

  • GOG-0129N
  • CDR0000368634

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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