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Docetaxel in Treating Patients With Recurrent or Persistent Endometrial Carcinoma (Cancer)

10. januar 2014 opdateret af: Gynecologic Oncology Group

A Phase II Evaluation of Weekly Docetaxel (NSC #628503) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with recurrent or persistent endometrial carcinoma (cancer).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

  • Determine the antitumor activity of docetaxel in patients with recurrent or persistent endometrial carcinoma.
  • Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 10-18 months.

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

  • Australien
    • New South Wales
      • Camperdown, New South Wales, Australien, 1450
        • Australia New Zealand Gynaecological Oncology Trials Group
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre - Calgary
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294-3300
        • Comprehensive Cancer Center at University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85006-2726
        • CCOP - Western Regional, Arizona
    • California
      • Los Angeles, California, Forenede Stater, 90095-1740
        • Jonsson Comprehensive Cancer Center at UCLA
      • Los Gatos, California, Forenede Stater, 95032
        • Women's Cancer Center - Los Gatos
      • Orange, California, Forenede Stater, 92868
        • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
    • Colorado
      • Denver, Colorado, Forenede Stater, 80010
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06520-8028
        • Yale Comprehensive Cancer Center
    • Delaware
      • Newark, Delaware, Forenede Stater, 19713
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20307-5001
        • Walter Reed Army Medical Center
    • Florida
      • Tampa, Florida, Forenede Stater, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96813
        • MBCCOP - Hawaii
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, Forenede Stater, 60612
        • MBCCOP - University of Illinois at Chicago
      • Chicago, Illinois, Forenede Stater, 60612-3824
        • Rush University Medical Center
      • Decatur, Illinois, Forenede Stater, 62794-9640
        • CCOP - Central Illinois
      • Evanston, Illinois, Forenede Stater, 60201
        • CCOP - Evanston
      • Urbana, Illinois, Forenede Stater, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202-5289
        • Indiana University Cancer Center
      • South Bend, Indiana, Forenede Stater, 46617
        • Saint Joseph Regional Medical Center
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242-1002
        • Holden Comprehensive Cancer Center at University of Iowa
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536-0084
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02111
        • Cancer Center at Tufts - New England Medical Center
      • Worcester, Massachusetts, Forenede Stater, 01605-2982
        • UMASS Memorial Cancer Center - University Campus
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • CCOP - Grand Rapids
      • Kalamazoo, Michigan, Forenede Stater, 49007-3731
        • CCOP - Kalamazoo
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • University of Minnesota Cancer Center
      • Rochester, Minnesota, Forenede Stater, 55905-0001
        • Mayo Clinic Cancer Center
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • CCOP - Metro-Minnesota
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216-4505
        • University of Mississippi Medical Center
      • Keesler AFB, Mississippi, Forenede Stater, 39534-2576
        • Keesler Medical Center - Keesler Air Force Base
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Kansas City, Missouri, Forenede Stater, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital
      • Springfield, Missouri, Forenede Stater, 65807
        • CCOP - Cancer Research for the Ozarks
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68106
        • CCOP - Missouri Valley Cancer Consortium
    • New Jersey
      • Camden, New Jersey, Forenede Stater, 08103-1489
        • Cancer Institute of New Jersey at the Cooper University Hospital
    • New York
      • Brooklyn, New York, Forenede Stater, 11203
        • SUNY Downstate Medical Center
      • Buffalo, New York, Forenede Stater, 14263-0001
        • Roswell Park Cancer Institute
      • Manhasset, New York, Forenede Stater, 11030
        • North Shore University Hospital
      • New York, New York, Forenede Stater, 10021
        • Memorial Sloan-Kettering Cancer Center
      • Stony Brook, New York, Forenede Stater, 11790-7775
        • Long Island Cancer Center at Stony Brook University Hospital
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599-7570
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Comprehensive Cancer Center
      • Greenville, North Carolina, Forenede Stater, 27858
        • Gynecologic Oncology Network
      • Winston-Salem, North Carolina, Forenede Stater, 27157-1065
        • Comprehensive Cancer Center at Wake Forest University
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45267-0520
        • Charles M. Barrett Cancer Center at University Hospital
      • Cleveland, Ohio, Forenede Stater, 44124
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, Forenede Stater, 44106
        • Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
      • Columbus, Ohio, Forenede Stater, 43210-1240
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • University of Oklahoma College of Medicine
    • Oregon
      • Portland, Oregon, Forenede Stater, 97225
        • CCOP - Columbia River Oncology Program
    • Pennsylvania
      • Abington, Pennsylvania, Forenede Stater, 19001-3788
        • Abington Memorial Hospital
      • Danville, Pennsylvania, Forenede Stater, 17822-2001
        • CCOP - Geisinger Clinic and Medical Center
      • Hershey, Pennsylvania, Forenede Stater, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19104-4283
        • Abramson Cancer Center of the University of Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213-3180
        • UPMC Cancer Center at Magee-Womens Hospital
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37917
        • Southeast Gynecologic Oncology Associates
      • Nashville, Tennessee, Forenede Stater, 37232-2516
        • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
    • Texas
      • Dallas, Texas, Forenede Stater, 75390-9032
        • Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
      • Galveston, Texas, Forenede Stater, 77555-0587
        • University of Texas Medical Branch
      • Houston, Texas, Forenede Stater, 77030-4009
        • MD Anderson Cancer Center at University of Texas
      • Temple, Texas, Forenede Stater, 76508
        • CCOP - Scott and White Hospital
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05401
        • Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • Cancer Center at the University of Virginia
    • Washington
      • Seattle, Washington, Forenede Stater, 98109-1024
        • Fred Hutchinson Cancer Research Center
      • Tacoma, Washington, Forenede Stater, 98405
        • MultiCare Regional Cancer Center at Tacoma General Hospital
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792-6188
        • University of Wisconsin Comprehensive Cancer Center
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • CCOP - Marshfield Clinic Research Foundation
  • Japan
      • Kagoshima City, Japan, 892-8580
        • Kagoshima City Hospital
  • Norge
      • Oslo, Norge, N-0310
        • Norwegian Radium 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 confirmed endometrial carcinoma

    • Recurrent or persistent disease
    • Refractory to curative or standard therapy

  • Measurable disease

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

    • At least 1 target lesion

      • Tumors within a previously irradiated field are not considered target lesions

  • Received 1 prior chemotherapy regimen for endometrial carcinoma, including high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment

    • One additional non-cytotoxic regimen for recurrent or persistent disease allowed, including monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction
  • Ineligible for a higher priority GOG protocol

PATIENT CHARACTERISTICS:

Age

  • Any age

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • SGOT ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Bilirubin ≤ 1.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No neuropathy (sensory and motor) ≥ grade 2
  • No active infection requiring antibiotics
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • At least 3 weeks since prior biologic or immunologic therapy for malignant tumor
  • No concurrent prophylactic growth factors
  • No concurrent prophylactic thrombopoietic agents

Chemotherapy

  • See Disease Characteristics
  • Recovered from prior chemotherapy
  • No more than 1 prior cytotoxic chemotherapy regimen (single or combination cytotoxic drugs)

Endocrine therapy

  • At least 1 week since prior hormonal therapy for malignant tumor
  • Concurrent hormone replacement therapy allowed

Radiotherapy

  • See Disease Characteristics
  • Recovered from prior radiotherapy

Surgery

  • Recovered from prior surgery

Other

  • At least 3 weeks since other prior therapy for malignant tumor
  • No prior anticancer therapy that would preclude current protocol therapy
  • No concurrent amifostine or other protective reagents

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
  • Maskning: Ingen (Åben etiket)

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)

Efterforskere

  • Studiestol: Agustin Garcia, MD, Premiere Oncology

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. juli 2004

Primær færdiggørelse (Faktiske)

1. december 2005

Datoer for studieregistrering

Først indsendt

10. juni 2004

Først indsendt, der opfyldte QC-kriterier

10. juni 2004

Først opslået (Skøn)

11. juni 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. januar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. januar 2014

Sidst verificeret

1. januar 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GOG-0129N
  • CDR0000368634

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 Endometriecancer

Kliniske forsøg med docetaxel

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Uganda

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner