Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer

Last updated: April 10, 2013
Sponsor: Gynecologic Oncology Group
Overall Status: Terminated

Phase

3

Condition

Endometrial Cancer

Endometriosis

Vaginal Cancer

Treatment

N/A

Clinical Study ID

NCT00016341
CDR0000068624
GOG-0189
  • Female

Study Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Estrogen can stimulate the growth of tumor cells. Hormone therapy using tamoxifen and megestrol may fight endometrial cancer by blocking the absorption of estrogen. It is not yet known whether chemotherapy is more effective than hormone therapy in treating endometrial cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with that of hormone therapy in treating patients who have recurrent, stage III, or stage IV endometrial cancer.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary stage III or IV or recurrent endometrial cancer

  • Poor curative potential with radiotherapy or surgery (alone or in combination)

  • Measurable disease

  • At least one lesion accurately measured in at least one dimension

  • At least 20 mm by conventional techniques, including palpation, x-ray, CT scan, or MRI OR

  • At least 10 mm by spiral CT scan

  • Disease in a previously irradiated field as sole site of measurable disease allowed only if clear progression after completion of radiotherapy

  • Estrogen receptor(ER)/progesterone receptor (PR) status of primary tumor required

  • ER/PR status of measurable tumor optional

PATIENT CHARACTERISTICS:

Age:

  • Not specified

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:

  • Bilirubin normal

  • SGPT no greater than 3 times upper limit of normal

Renal:

  • Creatinine no greater than 1.6 mg/dL

Cardiovascular:

  • LVEF at least 50%

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

  • Other conduction abnormalities or cardiac dysfunction allowed at the investigator's discretion

  • No history of deep venous thrombosis

  • No uncontrolled angina

Pulmonary:

  • No history of pulmonary embolus

Other:

  • No other malignancy within the past 5 years except nonmelanoma skin cancer

  • No concurrent medical illness that would preclude study

  • No serious uncontrolled infection

  • No serious peripheral neuropathy

  • No circumstances that would preclude study compliance

  • No sensitivity to E. coli-derived drug preparations

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Prior biologic therapy allowed

Chemotherapy:

  • No prior cytotoxic chemotherapy, including chemotherapy for radiosensitization

Endocrine therapy:

  • No prior hormonal therapy for endometrial cancer

Radiotherapy:

  • See Disease Characteristics

  • At least 4 weeks since prior radiotherapy involving the whole pelvis or more than 50% of the spine

Surgery:

  • See Disease Characteristics

Other:

  • Concurrent cardiac conduction-altering medications such as digitalis, beta blockers, or calcium channel blockers allowed at the investigator's discretion

Study Design

Study Start date:
May 01, 2001
Estimated Completion Date:

Study Description

OBJECTIVES:

  • Compare the progression-free survival and response of patients with stage III or IV or recurrent endometrial cancer treated with doxorubicin, cisplatin, paclitaxel, and filgrastim (G-CSF) vs tamoxifen and megestrol.

  • Compare the survival of patients treated with these regimens.

  • Determine if progesterone receptor status provides information on whether patients are more likely to benefit from chemotherapy.

  • Compare the toxicity profiles of these treatment regimens in these patients.

  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, cross-over, multicenter study. Patients are stratified according to progesterone receptor status (negative vs positive). Patients are randomized to 1 of 2 treatment arms.

  • Arm I:Patients receive chemotherapy comprising doxorubicin IV over 15-30 minutes followed by cisplatin IV over 1 hour on day 1; paclitaxel IV over 3 hours on day 2; and filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing for 10 days. Chemotherapy repeats every 21 days for up to 7 courses in the absence of disease progression or unacceptable toxicity.

  • At time of disease progression, patients cross-over to hormonal therapy as in arm II.

  • Arm II: Patients receive hormonal therapy comprising oral megestrol twice daily on weeks 1-3 followed by oral tamoxifen twice daily on weeks 4-6. Hormonal therapy repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

At time of disease progression, if patients have not previously been enrolled on arm I, patients cross-over to receive chemotherapy as in arm I.

Quality of life is assessed at baseline, 6 weeks, time of progression, and then after 6 weeks on cross-over therapy.

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

PROJECTED ACCRUAL: Approximately 630 patients will be accrued for this study within 42 months.

Connect with a study center

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta T2N 4N2
    Canada

    Site Not Available

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama 35294-3300
    United States

    Site Not Available

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California 90095-1781
    United States

    Site Not Available

  • Community Hospital of Los Gatos

    Los Gatos, California 95032
    United States

    Site Not Available

  • Chao Family Comprehensive Cancer Center

    Orange, California 92868
    United States

    Site Not Available

  • University of Colorado Cancer Center

    Denver, Colorado 80010
    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 33612-9497
    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 60637-1470
    United States

    Site Not Available

  • Indiana University Cancer Center

    Indianapolis, Indiana 46202-5289
    United States

    Site Not Available

  • Holden Comprehensive Cancer Center at The University of Iowa

    Iowa City, Iowa 52242-1009
    United States

    Site Not Available

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky 40536-0084
    United States

    Site Not Available

  • Tufts University School of Medicine

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan 48201-1379
    United States

    Site Not Available

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Mayo Clinic Cancer Center

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216-4505
    United States

    Site Not Available

  • Ellis Fischel Cancer Center - Columbia

    Columbia, Missouri 65203
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    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

  • Roswell Park Cancer Institute

    Buffalo, New York 14263-0001
    United States

    Site Not Available

  • Schneider Children's Hospital at North Shore

    Manhasset, New York 11030
    United States

    Site Not Available

  • Memorial Sloan-Kettering Cancer Center

    New York, New York 10021
    United States

    Site Not Available

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

    Stony Brook, New York 11790-7775
    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 at Wake Forest University

    Winston-Salem, North Carolina 27157-1082
    United States

    Site Not Available

  • Barrett Cancer Center, The University Hospital

    Cincinnati, Ohio 45267-0502
    United States

    Site Not Available

  • Cleveland Clinic Taussig 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 43210-1240
    United States

    Site Not Available

  • University of Oklahoma College of Medicine

    Oklahoma City, Oklahoma 73190
    United States

    Site Not Available

  • Abington Memorial Hospital

    Abington, Pennsylvania 19001
    United States

    Site Not Available

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033-0850
    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 19107-5541
    United States

    Site Not Available

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania 19104-4283
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425-0721
    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

  • M.D. Anderson CCOP Research Base

    Houston, Texas 77030-4009
    United States

    Site Not Available

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas 77030-4009
    United States

    Site Not Available

  • Fletcher Allen Health Care - Medical Center Campus

    Burlington, Vermont 05401
    United States

    Site Not Available

  • Cancer Center at the University of Virginia

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington 98109-1024
    United States

    Site Not Available

  • Tacoma General Hospital

    Tacoma, Washington 98405
    United States

    Site Not Available

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