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Evaluation of Doxil in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus


Phase 2
21 Years
N/A
Not Enrolling
Female
Endometrial Cancer, Sarcoma

Thank you

Trial Information

Evaluation of Doxil in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus


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.

Inclusion 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

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Gregory P. Sutton, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067809

NCT ID:

NCT00005643

Start Date:

May 2000

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • Sarcoma
  • stage IV uterine sarcoma
  • recurrent uterine sarcoma
  • uterine carcinosarcoma
  • uterine leiomyosarcoma
  • endometrial stromal sarcoma
  • Endometrial Neoplasms
  • Leiomyosarcoma
  • Adenoma
  • Sarcoma

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
Cooper Hospital/University Medical CenterCamden, New Jersey  08103
Cancer Center of Albany Medical CenterAlbany, New York  12208
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Cancer Center, University of Virginia HSCCharlottesville, Virginia  22908
University of Washington Medical CenterSeattle, Washington  98195-6043
Tacoma General HospitalTacoma, Washington  98405
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Kansas CityKansas City, Missouri  64131
Community Hospital of Los GatosLos Gatos, California  95032
Tufts University School of MedicineBoston, Massachusetts  02111
Brookview Research, Inc.Nashville, Tennessee  37203
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
North Shore University HospitalManhasset, New York  11030
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
CCOP - Sooner StateTulsa, Oklahoma  74136
Radiation Oncology BranchBethesda, Maryland  20892
Ellis Fischel Cancer CenterColumbia, Missouri  65203