Combination Chemotherapy With or Without G-CSF in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer

Last updated: July 8, 2013
Sponsor: Gynecologic Oncology Group
Overall Status: Completed

Phase

3

Condition

Vaginal Cancer

Pelvic Cancer

Endometriosis

Treatment

N/A

Clinical Study ID

NCT00003691
CDR0000066794
GOG-0177
  • Ages > 18
  • Female

Study Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of doxorubicin and cisplatin with or without paclitaxel and G-CSF in treating patients who have stage III, stage IV, or recurrent endometrial cancer.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary stage III, stage IV, or recurrent endometrial carcinoma

  • Very poor potential for cure by radiotherapy or surgery alone or in combination

  • Measurable disease

  • Disease in an irradiated field as the only site of measurable disease allowed provided there has been clear progression since completion of radiotherapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Platelet count at least 100,000/mm^3

  • Granulocyte count at least 1,500/mm^3

Hepatic

  • SGPT no greater than 3 times upper limit of normal

  • Bilirubin normal

Renal

  • Creatinine no greater than 1.6 mg/dL

Cardiovascular

  • LVEF at least 50% within past 6 months

  • No uncontrolled angina

  • No third-degree or complete heart block unless a pacemaker is in place

Neurologic

  • No serious peripheral neuropathy

Other

  • No prior or concurrent malignancy within past 5 years except nonmelanoma skin cancer

  • No uncontrolled infection

  • No sensitivity to E. coli-derived drug preparations

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior biologic therapy allowed

  • No concurrent biologic therapy

Chemotherapy

  • No prior cytotoxic chemotherapy, including chemotherapy used for radiation sensitization

  • No prior chemotherapy for any prior malignancy

Endocrine therapy

  • Prior hormone therapy allowed

  • No concurrent hormone therapy

Radiotherapy

  • At least 4 weeks since prior radiotherapy to the whole pelvis or to over 50% of the spine

Surgery

  • Not specified

Study Design

Total Participants: 240
Study Start date:
December 01, 1998
Estimated Completion Date:

Study Description

OBJECTIVES:

  • Determine whether the addition of paclitaxel, using filgrastim (G-CSF) support, to standard doxorubicin/cisplatin chemotherapy produces improvement in the frequency of objective response, progression-free survival, or overall survival in patients with stage III, stage IV, or recurrent endometrial carcinoma.

  • Compare the toxicities of these two regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive doxorubicin IV over 15-30 minutes, followed immediately by cisplatin IV over 1 hour.

  • Arm II: Patients receive doxorubicin and cisplatin as in arm I on day 1. On day 2, patients receive paclitaxel IV over 3 hours. Patients also receive filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing for at least 10 days.

Courses are repeated every 21 days. Treatment continues for up to 7 courses in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 240 patients (120 per arm) will be accrued for this study within 21 months.

Connect with a study center

  • NCIC-Clinical Trials Group

    Kingston, Ontario K7L 3N6
    Canada

    Site Not Available

  • University of Alabama Comprehensive Cancer Center

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • CCOP - Greater Phoenix

    Phoenix, Arizona 85006-2726
    United States

    Site Not Available

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California 90095-1781
    United States

    Site Not Available

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California 90033-0800
    United States

    Site Not Available

  • Chao Family Comprehensive Cancer Center

    Orange, California 92868
    United States

    Site Not Available

  • Women's Cancer Center

    Palo Alto, California 94304
    United States

    Site Not Available

  • University of Colorado Cancer Center

    Denver, Colorado 80262
    United States

    Site Not Available

  • Vincent T. Lombardi Cancer Research Center, Georgetown University

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Walter Reed Army Medical Center

    Washington, District of Columbia 20307-5000
    United States

    Site Not Available

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida 33612
    United States

    Site Not Available

  • Emory University Hospital - Atlanta

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • MBCCOP - Hawaii

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • MBCCOP - University of Illinois at Chicago

    Chicago, Illinois 60612-7323
    United States

    Site Not Available

  • Rush-Presbyterian-St. Luke's Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Chicago Cancer Research Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • CCOP - Central Illinois

    Decatur, Illinois 62526
    United States

    Site Not Available

  • CCOP - Evanston

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Indiana University Cancer Center

    Indianapolis, Indiana 46202-5265
    United States

    Site Not Available

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa 50309-1016
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky 40536-0084
    United States

    Site Not Available

  • Johns Hopkins Oncology Center

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Medicine Branch

    Bethesda, Maryland 20892
    United States

    Site Not Available

  • Radiation Oncology Branch

    Bethesda, Maryland 20892
    United States

    Site Not Available

  • Tufts University School of Medicine

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Memorial Hospital

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • CCOP - Ann Arbor Regional

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Site Not Available

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216-4505
    United States

    Site Not Available

  • Keesler Medical Center - Keesler AFB

    Keesler AFB, Mississippi 39534-2576
    United States

    Site Not Available

  • CCOP - Kansas City

    Kansas City, Missouri 64131
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • CCOP - Montana Cancer Consortium

    Billings, Montana 59101
    United States

    Site Not Available

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska 68131
    United States

    Site Not Available

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Cooper Hospital/University Medical Center

    Camden, New Jersey 08103
    United States

    Site Not Available

  • Cancer Center of Albany Medical Center

    Albany, New York 12208
    United States

    Site Not Available

  • State University of New York Health Science Center at Brooklyn

    Brooklyn, New York 11203
    United States

    Site Not Available

  • North Shore University Hospital

    Manhasset, New York 11030
    United States

    Site Not Available

  • Memorial Sloan-Kettering Cancer Center

    New York, New York 10021
    United States

    Site Not Available

  • University of Rochester Cancer Center

    Rochester, New York 14642
    United States

    Site Not Available

  • State University of New York Health Sciences Center - Stony Brook

    Stony Brook, New York 11790-9832
    United States

    Site Not Available

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina 27599-7295
    United States

    Site Not Available

  • Duke Comprehensive Cancer Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina 27157-1082
    United States

    Site Not Available

  • Barrett Cancer Center, The University Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Cleveland Clinic Cancer Center

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Ireland Cancer Center

    Cleveland, Ohio 44106-5065
    United States

    Site Not Available

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • University of Oklahoma College of Medicine

    Oklahoma City, Oklahoma 73190
    United States

    Site Not Available

  • CCOP - Sooner State

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • CCOP - Columbia River Program

    Portland, Oregon 97213
    United States

    Site Not Available

  • Abington Memorial Hospital

    Abington, Pennsylvania 19001
    United States

    Site Not Available

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania 19096
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425-0721
    United States

    Site Not Available

  • CCOP - Greenville

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • CCOP - Baptist Cancer Institute

    Memphis, Tennessee 38117
    United States

    Site Not Available

  • Brookview Research, Inc.

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Simmons Cancer Center - Dallas

    Dallas, Texas 75235-9154
    United States

    Site Not Available

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • CCOP - Scott and White Hospital

    Temple, Texas 76508
    United States

    Site Not Available

  • Cancer Center, University of Virginia HSC

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98195-6043
    United States

    Site Not Available

  • Tacoma General Hospital

    Tacoma, Washington 98405
    United States

    Site Not Available

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