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

10. januar 2014 oppdatert av: 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).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Masking: Ingen (Open Label)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Gynecologic Oncology Group

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Studiestol: Agustin Garcia, MD, Premiere Oncology

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2004

Primær fullføring (Faktiske)

1. desember 2005

Datoer for studieregistrering

Først innsendt

10. juni 2004

Først innsendt som oppfylte QC-kriteriene

10. juni 2004

Først lagt ut (Anslag)

11. juni 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

13. januar 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. januar 2014

Sist bekreftet

1. januar 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • GOG-0129N
  • CDR0000368634

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere