Chemotherapy in Treating Patients With Sarcoma of the Uterus

Last updated: June 7, 2013
Sponsor: Gynecologic Oncology Group
Overall Status: Completed

Phase

2

Condition

Endometriosis

Sarcoma (Pediatric)

Vaginal Cancer

Treatment

N/A

Clinical Study ID

NCT00005643
CDR0000067809
GOG-0087J
  • Ages > 21
  • Female

Study Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients who have advanced or recurrent sarcoma of the uterus.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS: Histologically confirmed advanced, persistent or recurrent uterine sarcoma with documented disease progression after appropriate local therapy Leiomyosarcoma Malignant mixed mullerian tumor (mixed mesodermal tumor, mixed heterologous mesenchymal sarcoma) Mixed malignant Muellerian tumor (carcinosarcoma, homologous mesenchymal sarcoma) Endometrial stromal sarcoma Other uterine sarcomas Considered incurable Bidimensionally measurable disease consisting of abdominal, pelvic, chest, or other masses by palpation, x-ray, computed tomography, or ultrasound

PATIENT CHARACTERISTICS: Age: Over 21 Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: LVEF normal by MUGA scan Other: No clinically significant infection No other malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior therapy with cytotoxic drugs No prior doxorubicin HCl liposome No prior doxorubicin greater than 360 mg/m2 No other concurrent antineoplastic agents Endocrine therapy: Not specified Radiotherapy: Recovered from prior radiotherapy No prior radiotherapy for any other malignancy Surgery: Recovered from prior surgery Other: No other concurrent investigational agents

Study Design

Study Start date:
May 01, 2000
Estimated Completion Date:

Study Description

OBJECTIVES: I. Estimate the antitumor activity of doxorubicin HCl liposome in patients with recurrent or advanced uterine sarcoma. II. Determine the nature and degree of toxicity of this drug in this patient population.

OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 1-1.5 years.

Connect with a study center

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta T2N 4N2
    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

  • 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 80262
    United States

    Site Not Available

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida 33612
    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

  • Indiana University Cancer Center

    Indianapolis, Indiana 46202-5265
    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

  • Radiation Oncology Branch

    Bethesda, Maryland 20892
    United States

    Site Not Available

  • Tufts University School of Medicine

    Boston, Massachusetts 02111
    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

  • 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, Missouri 65203
    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 - Cancer Research for the Ozarks

    Springfield, Missouri 65807
    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

  • North Shore University Hospital

    Manhasset, New York 11030
    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 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 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
    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

  • 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

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania 19096
    United States

    Site Not Available

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina 29303
    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 77030-4009
    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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