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

Phase 2
Not Enrolling

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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:


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


United States: Federal Government

Study ID:




Start Date:

August 1997

Completion Date:

Related Keywords:

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



Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Alabama Comprehensive Cancer Center Birmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
Chao Family Comprehensive Cancer Center Orange, California  92868
University of Colorado Cancer Center Denver, Colorado  80262
Vincent T. Lombardi Cancer Research Center, Georgetown University Washington, District of Columbia  20007
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Emory University Hospital - Atlanta Atlanta, Georgia  30322
MBCCOP - Hawaii Honolulu, Hawaii  96813
Rush-Presbyterian-St. Luke's Medical Center Chicago, Illinois  60612
University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Johns Hopkins Oncology Center Baltimore, Maryland  21287
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Washington University School of Medicine Saint Louis, Missouri  63110
Cooper Hospital/University Medical Center Camden, New Jersey  08103
Cancer Center of Albany Medical Center Albany, New York  12208
State University of New York Health Science Center at Brooklyn Brooklyn, New York  11203
University of Rochester Cancer Center Rochester, New York  14642
State University of New York Health Sciences Center - Stony Brook Stony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Cleveland Clinic Cancer Center Cleveland, Ohio  44195
Ireland Cancer Center Cleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
University of Oklahoma College of Medicine Oklahoma City, Oklahoma  73190
Abington Memorial Hospital Abington, Pennsylvania  19001
Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Medical University of South Carolina Charleston, South Carolina  29425-0721
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
Cancer Center, University of Virginia HSC Charlottesville, Virginia  22908
University of Washington Medical Center Seattle, Washington  98195-6043
Tacoma General Hospital Tacoma, Washington  98405
CCOP - Greater Phoenix Phoenix, Arizona  85006-2726
Women's Cancer Center Palo Alto, California  94304
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
Brookview Research, Inc. Winston-Salem, North Carolina  27103
Pennsylvania Hospital Philadelphia, Pennsylvania  19107
CCOP - Baptist Cancer Institute Memphis, Tennessee  38117
CCOP - Central Illinois Springfield, Illinois  62526
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbia River Program Portland, Oregon  97213
CCOP - Evanston Evanston, Illinois  60201
North Shore University Hospital Manhasset, New York  11030
Medical College of Georgia Comprehensive Cancer Center Augusta, Georgia  30912-4000
Medicine Branch Bethesda, Maryland  20892
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center Tulsa, Oklahoma  74136
Radiation Oncology Branch Bethesda, Maryland  20892