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Evaluation of Gemcitabine in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus


Phase 2
18 Years
N/A
Not Enrolling
Female
Sarcoma

Thank you

Trial Information

Evaluation of Gemcitabine in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus


OBJECTIVES: I. Determine the antitumor activity of gemcitabine in patients with recurrent or
persistent leiomyosarcoma of the uterus who failed higher priority treatment protocols. II.
Determine the toxicity of gemcitabine in these patients.

OUTLINE: Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Courses repeat
every 4 weeks in the absence of unacceptable toxicity and disease progression. Patients with
partial response, complete response, or stable disease receive at least 3 courses of
therapy. Patients are followed every 3 months for 2 years, then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed recurrent or persistent uterine
leiomyosarcoma that is refractory to curative therapy or standard treatments Failed local
therapeutic measures and considered incurable Measurable disease Not eligible for a higher
priority GOG protocol

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 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 no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal
Renal: Creatinine no greater than 1.5 mg/dL Other: No significant infection At least 5
years since any other invasive malignancy except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy
Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No prior gemcitabine
No more than 1 prior chemotherapy regimen (single agent or combination therapy) Endocrine
therapy: At least 3 weeks since prior endocrine therapy Radiotherapy: At least 3 weeks
since prior radiotherapy and recovered Surgery: At least 3 weeks since prior surgery and
recovered

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Katherine Y. Look, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066265

NCT ID:

NCT00003316

Start Date:

August 1998

Completion Date:

Related Keywords:

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

Name

Location

University of Alabama Comprehensive Cancer Center Birmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Chao Family Comprehensive Cancer Center Orange, California  92868
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
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
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
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
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
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
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
University of Washington Medical Center Seattle, Washington  98195-6043
Tacoma General Hospital Tacoma, Washington  98405
CCOP - Greater Phoenix Phoenix, Arizona  85006-2726
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
Tufts University School of Medicine Boston, Massachusetts  02111
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Radiation Oncology Branch Bethesda, Maryland  20892