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Combination Chemotherapy Plus Sargramostim in Treating Patients With Cancer of the Uterus

10. april 2013 opdateret af: Gynecologic Oncology Group

A Phase II Evaluation of DMAP Plus GM-CSF in the Treatment of Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus sargramostim in treating patients who have advanced, persistent, or recurrent cancer of the uterus.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

  • Determine the antitumor activity of dacarbazine, mitomycin, doxorubicin, and cisplatin plus sargramostim (GM-CSF) in patients with advanced, persistent, or recurrent leiomyosarcoma of the uterus.
  • Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: Patients receive dacarbazine IV over 2 hours, followed by mitomycin IV over 2-5 minutes, doxorubicin IV over 2-5 minutes, and cisplatin IV over 2 hours on day 1. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) once every 12 hours on days -6 to -3 before the first chemotherapy course and then on days 2-15 and 23-26 of all chemotherapy courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease receive a maximum of 4 courses. Patients achieving complete or partial response receive a maximum of 6 courses.

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

PROJECTED ACCRUAL: A total of 12-43 patients will be accrued for this study within 12-28 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

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
    • Colorado
      • Denver, Colorado, Forenede Stater, 80010
        • University of Colorado Cancer Center
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20307-5001
        • Walter Reed Army Medical Center
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612-3864
        • Rush-Presbyterian-St. Luke's Medical Center
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242-1009
        • Holden Comprehensive Cancer Center
    • Maryland
      • Bethesda, Maryland, Forenede Stater, 20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02111
        • Tuft-New England Medical Center
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905-0001
        • Mayo Clinic Cancer Center
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
    • New Jersey
      • Camden, New Jersey, Forenede Stater, 08103-1489
        • Cooper University Hospital
    • New York
      • Stony Brook, New York, Forenede Stater, 11794-8091
        • 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, 27157-1065
        • Comprehensive Cancer Center at Wake Forest University
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45267-0526
        • Barrett Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73190
        • University of Oklahoma College of Medicine
    • Pennsylvania
      • Abington, Pennsylvania, Forenede Stater, 19001-3788
        • Abington Memorial Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19104-4283
        • University of Pennsylvania Cancer Center
    • Texas
      • Galveston, Texas, Forenede Stater, 77555-0587
        • University of Texas Medical Branch
    • Washington
      • Tacoma, Washington, Forenede Stater, 98405
        • Tacoma General 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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary leiomyosarcoma (LMS) of the uterus

    • Advanced, persistent, or recurrent disease that is refractory to curative therapy or established treatments

  • At least 1 unidimensionally measurable target lesion

    • At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR
    • At least 10 mm by spiral CT scan
    • Tumors within a previously irradiated field are designated as non-target lesions
  • Ineligible for a higher priority Gynecologic Oncology Group protocol (if one exists), including any active phase III protocol for the same population

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Other:

  • No active infection requiring antibiotics
  • No grade 2 or greater sensory or motor neuropathy
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior cytotoxic chemotherapy for LMS of the uterus

Endocrine therapy:

  • At least 1 week since prior hormonal therapy for LMS of the uterus
  • Concurrent hormone replacement therapy allowed

Radiotherapy:

  • See Disease Characteristics
  • Recovered from prior recent radiotherapy

Surgery:

  • Recovered from prior recent surgery

Other:

  • Recovered from other prior recent therapy
  • No prior cancer treatment that would preclude study therapy

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. marts 2002

Primær færdiggørelse (Faktiske)

1. oktober 2005

Datoer for studieregistrering

Først indsendt

9. april 2002

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. april 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. april 2013

Sidst verificeret

1. september 2004

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000069308
  • GOG-0087K

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 cisplatin

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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CROs in Slovenia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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