Know Cancer

forgot password

Evaluation of Topotecan in the Treatment of Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus

Phase 2
Not Enrolling

Thank you

Trial Information

Evaluation of Topotecan in the Treatment of Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus

OBJECTIVES: I. Estimate the antitumor activity of topotecan in patients with recurrent or
refractory carcinosarcoma of the uterus who have failed standard therapy. II. Determine the
nature and degree of toxic effects of topotecan in these patients.

OUTLINE: Patients receive topotecan IV over 30 minutes daily for 5 days. Treatment repeats
every 3 weeks for a minimum of 1 course in the absence of disease progression or
unacceptable toxicity. Patients with complete response, partial response, or stable disease
continue treatment for at least three courses. Patients are followed every 4 months for 2
years, every 6 months for 3 years, and then periodically thereafter until death.

PROJECTED ACCRUAL: Approximately 25-40 patients will be accrued for this study within 2

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory carcinosarcoma
(mixed mesodermal tumors) of the uterus Measurable disease

PATIENT CHARACTERISTICS: Age: Not specified Performance Status: GOG 0-2 Life Expectancy:
Not specified Hematopoietic: Platelet count at least 100,000/mm3 Absolute granulocyte
count at least 1,500/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 Creatinine clearance greater than 20
mL/min Other: No invasive malignancies within the past 5 years except nonmelanomatous skin
cancer No significant infection

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 topotecan
or camptothecin therapy No more than 1 prior chemotherapy regimen (either single or
combination chemotherapy) Endocrine therapy: At least 3 weeks since prior endocrine
therapy Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery:
Prior surgery allowed and recovered

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David S. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center


United States: Federal Government

Study ID:




Start Date:

June 1998

Completion Date:

Related Keywords:

  • Sarcoma
  • recurrent uterine sarcoma
  • uterine carcinosarcoma
  • Carcinosarcoma
  • Uterine Neoplasms
  • Sarcoma



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
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
Cancer Center of Albany Medical Center Albany, New York  12208
State University of New York Health Science Center at Brooklyn Brooklyn, New York  11203
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
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
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
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 - Kansas City Kansas City, Missouri  64131
CCOP - Baptist Cancer Institute Memphis, Tennessee  38117
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Community Hospital of Los Gatos Los Gatos, California  95032
Tufts University School of Medicine Boston, Massachusetts  02111
Brookview Research, Inc. Nashville, Tennessee  37203
Fletcher Allen Health Care Burlington, Vermont  05401
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
CCOP - Scott and White Hospital Temple, Texas  76508
North Shore University Hospital Manhasset, New York  11030
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
CCOP - Sooner State Tulsa, Oklahoma  74136
Radiation Oncology Branch Bethesda, Maryland  20892