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


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

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
years.

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:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David S. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000065948

NCT ID:

NCT00003156

Start Date:

June 1998

Completion Date:

Related Keywords:

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

Name

Location

University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer CenterOrange, California  92868
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
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
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
Cancer Center of Albany Medical CenterAlbany, New York  12208
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
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
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 - Kansas CityKansas City, Missouri  64131
CCOP - Baptist Cancer InstituteMemphis, Tennessee  38117
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Community Hospital of Los GatosLos Gatos, California  95032
Tufts University School of MedicineBoston, Massachusetts  02111
Brookview Research, Inc.Nashville, Tennessee  37203
Fletcher Allen Health CareBurlington, Vermont  05401
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
CCOP - Scott and White HospitalTemple, Texas  76508
North Shore University HospitalManhasset, New York  11030
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
CCOP - Sooner StateTulsa, Oklahoma  74136
Radiation Oncology BranchBethesda, Maryland  20892