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

January 10, 2014 updated by: 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Agustin Garcia, MD, Premiere Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

June 10, 2004

First Submitted That Met QC Criteria

June 10, 2004

First Posted (Estimate)

June 11, 2004

Study Record Updates

Last Update Posted (Estimate)

January 13, 2014

Last Update Submitted That Met QC Criteria

January 10, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOG-0129N
  • CDR0000368634

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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