Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Topotecan in Treating Patients With Recurrent or Refractory Cancer of the Uterus

10. april 2013 opdateret af: Gynecologic Oncology Group

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

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of topotecan in treating patients with recurrent or refractory cancer of the uterus.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Center - Calgary
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • University of Alabama Comprehensive Cancer Center
    • California
      • Los Angeles, California, Forenede Stater, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Gatos, California, Forenede Stater, 95032
        • Community Hospital of Los Gatos
      • Orange, California, Forenede Stater, 92868
        • Chao Family Comprehensive Cancer Center
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20307-5000
        • Walter Reed Army Medical Center
    • Florida
      • Tampa, Florida, Forenede Stater, 33612
        • H. Lee Moffitt Cancer Center and Research Institute
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush-Presbyterian-St. Luke's Medical Center
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago Cancer Research Center
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202-5265
        • Indiana University Cancer Center
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • University of Iowa Hospitals and Clinics
    • Maryland
      • Bethesda, Maryland, Forenede Stater, 20892
        • Radiation Oncology Branch
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02111
        • Tufts University School of Medicine
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • Barbara Ann Karmanos Cancer Institute
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • University of Minnesota Cancer Center
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216-4505
        • University of Mississippi Medical Center
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65203
        • Ellis Fischel Cancer Center - Columbia
      • Kansas City, Missouri, Forenede Stater, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Cancer Center of Albany Medical Center
      • Brooklyn, New York, Forenede Stater, 11203
        • State University of New York Health Science Center at Brooklyn
      • Manhasset, New York, Forenede Stater, 11030
        • North Shore University Hospital
      • Stony Brook, New York, Forenede Stater, 11790-7775
        • State University of New York Health Sciences Center - Stony Brook
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599-7295
        • Lineberger Comprehensive Cancer Center, UNC
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Comprehensive Cancer Center
      • Winston-Salem, North Carolina, Forenede Stater, 27157-1082
        • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Barrett Cancer Center, The University Hospital
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, Forenede Stater, 44106-5065
        • Ireland Cancer Center
      • Columbus, Ohio, Forenede Stater, 43210
        • Arthur G. James Cancer Hospital - Ohio State University
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73190
        • University of Oklahoma College of Medicine
      • Tulsa, Oklahoma, Forenede Stater, 74136
        • CCOP - Sooner State
    • Pennsylvania
      • Abington, Pennsylvania, Forenede Stater, 19001
        • Abington Memorial Hospital
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania Cancer Center
      • Wynnewood, Pennsylvania, Forenede Stater, 19096
        • CCOP - MainLine Health
    • South Carolina
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • CCOP - Upstate Carolina
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38117
        • CCOP - Baptist Cancer Institute
      • Nashville, Tennessee, Forenede Stater, 37203
        • Brookview Research, Inc.
    • Texas
      • Dallas, Texas, Forenede Stater, 75235-9154
        • Simmons Cancer Center - Dallas
      • Temple, Texas, Forenede Stater, 76508
        • CCOP - Scott and White Hospital
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05401
        • Fletcher Allen Health Care
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • Cancer Center, University of Virginia HSC
    • Washington
      • Seattle, Washington, Forenede Stater, 98195-6043
        • University of Washington Medical Center
      • Tacoma, Washington, Forenede Stater, 98405
        • Tacoma General Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Gynecologic Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 1998

Primær færdiggørelse (Faktiske)

1. oktober 2005

Datoer for studieregistrering

Først indsendt

6. november 2000

Først indsendt, der opfyldte QC-kriterier

6. april 2004

Først opslået (Skøn)

7. april 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. april 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. april 2013

Sidst verificeret

1. januar 2006

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000065948
  • GOG-130D

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Sarkom

Kliniske forsøg med topotecanhydrochlorid

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Ukraine

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner