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Evaluation of Paclitaxel (Taxol) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus


Phase 2
N/A
N/A
Not Enrolling
Female
Sarcoma

Thank you

Trial Information

Evaluation of Paclitaxel (Taxol) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus


OBJECTIVES: I. Estimate the antitumor activity of paclitaxel in patients with metastatic or
persistent leiomyosarcoma of the uterus who have failed treatment protocols of higher
priority. II. Determine the nature and degree of toxic effects of paclitaxel in this group
of patients.

OUTLINE: Patients receive a continuous infusion of paclitaxel once every 3 weeks over 3
hours. Patients in complete remission, partial remission, or stable disease undergo at least
3 courses of paclitaxel. Paclitaxel continues until disease progression or adverse effects
prohibit further treatment. All patients are followed until death.

PROJECTED ACCRUAL: This study anticipates an annual accrual of approximately 25 patients
over 2.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed recurrent or persistent uterine
leiomyosarcoma that is refractory to curative therapy or established treatments Measurable
disease required Must have failed local therapeutic measures and must be considered
incurable Not eligible for GOG protocols of higher priority

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-3 Life expectancy:
Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3
Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times normal
SGOT and alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater
than 2.0 mg/dL Cardiovascular: No unstable angina within 6 months OR No myocardial
infarction within 6 months Abnormal cardiac condition (e.g., bundle branch block, heart
block) allowed if stable for 6 months Other: No significant infection No concomitant
malignancy other than nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: At least 3 weeks since prior therapy to malignant tumor Biologic
therapy: Not specified Chemotherapy: Recovery from prior chemotherapy required No more
than 1 prior chemotherapy regimen allowed No prior paclitaxel No prior chemotherapy for
any malignancy from which the patient is disease-free for at least 5 years Endocrine
therapy: Not specified Radiotherapy: Recovery from prior radiation therapy required No
prior radiation therapy for any malignancy from which the patient is disease-free for at
least 5 years Surgery: Recovery from prior surgery required

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Donald G. Gallup, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000065702

NCT ID:

NCT00003054

Start Date:

August 1997

Completion Date:

Related Keywords:

  • Sarcoma
  • recurrent uterine sarcoma
  • uterine leiomyosarcoma
  • Leiomyosarcoma
  • Uterine Neoplasms
  • Sarcoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Vincent T. Lombardi Cancer Research Center, Georgetown UniversityWashington, District of Columbia  20007
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
MBCCOP - HawaiiHonolulu, Hawaii  96813
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
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
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 Science Center at BrooklynBrooklyn, New York  11203
University of Rochester Cancer CenterRochester, New York  14642
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
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
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
Medical University of South CarolinaCharleston, South Carolina  29425-0721
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
Women's Cancer CenterPalo Alto, California  94304
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
Brookview Research, Inc.Winston-Salem, North Carolina  27103
Pennsylvania HospitalPhiladelphia, Pennsylvania  19107
CCOP - Baptist Cancer InstituteMemphis, Tennessee  38117
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - Columbia River ProgramPortland, Oregon  97213
CCOP - EvanstonEvanston, Illinois  60201
North Shore University HospitalManhasset, New York  11030
Medical College of Georgia Comprehensive Cancer CenterAugusta, Georgia  30912-4000
Medicine BranchBethesda, Maryland  20892
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer CenterTulsa, Oklahoma  74136
Radiation Oncology BranchBethesda, Maryland  20892