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Home > "C" Clinical Trials Conditions > Chemotherapy in Treating Patients With Sarcoma of the Uterus  Chemotherapy in Treating Patients With Sarcoma of the Uterus
Chemotherapy in Treating Patients With Sarcoma of the Uterus
For Condition: uterine leiomyosarcoma,recurrent uterine sarcoma,uterine carcinosarcoma,stage 4 uterine sarcoma,Endometrial Stromal Sarcoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Gynecologic Oncology Group
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 21 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GregorySutton, Study Chair, Gynecologic Oncology Group
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Brookview Research, Inc.
Nashville, Tennessee, 37203
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, 22908
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
CCOP - Sooner State
Tulsa, Oklahoma, 74136
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265
United States
Cancer Center of Albany Medical Center
Albany, New York, 12208
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Tufts University School of Medicine
Boston, Massachusetts, 02111
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
United States
Tacoma General Hospital
Tacoma, Washington, 98405
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
United States
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103
United States
Community Hospital of Los Gatos
Los Gatos, California, 95032
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Radiation Oncology Branch
Bethesda, Maryland, 20892
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219
United States
University of Colorado Cancer Center
Denver, Colorado, 80262
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001
United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, 27157-1082
United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Ellis Fischel Cancer Center
Columbia, Missouri, 65203
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
University of Washington Medical Center
Seattle, Washington, 98195-6043
United States
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
United States
Additional Information:
Study ID Numbers: CDR0000067809; GOG-0087J
Study Start Date: May 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005643
Other Endometrial Stromal Sarcoma Studies:
1. Combination Chemotherapy in Treating Patients With Endometrial Cancer, Fallopian Tube Cancer, or Sarcoma of the Female Reproductive Tract
2. Chemotherapy in Treating Patients With Sarcoma of the Uterus
3. Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Cancer of the Uterus
Related Studies:
Other Endometrial Stromal Sarcoma Clinical Trials
Other New York Clinical Trials
Other Stony Brook Clinical Trials
Chemotherapy in Treating Patients With Sarcoma of the Uterus
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