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Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer

20. juni 2013 opdateret af: Gynecologic Oncology Group

Phase II Evaluation of Oxaliplatin in the Treatment of Recurrent or Persistent Endometrial Carcinoma

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

PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have persistent or recurrent endometrial cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

  • Determine the antitumor activity of oxaliplatin in terms of response rate in patients with persistent or recurrent endometrial carcinoma that is refractory to curative or established therapy.
  • Determine the nature and degree of toxicity of this treatment regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks 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: Approximately 19-51 patients will be accrued for this study.

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
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294-3300
        • University of Alabama at Birmingham Comprehensive Cancer Center
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85006-2726
        • CCOP - Western Regional, Arizona
    • California
      • Orange, California, Forenede Stater, 92868
        • Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
    • Colorado
      • Denver, Colorado, Forenede Stater, 80010
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center
    • Connecticut
      • New Britain, Connecticut, Forenede Stater, 06052
        • New Britain General Hospital
    • Delaware
      • Newark, Delaware, Forenede Stater, 19713
        • CCOP - Christiana Care Health Services
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, Forenede Stater, 60612
        • MBCCOP - University of Illinois at Chicago
      • 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
      • South Bend, Indiana, Forenede Stater, 46617
        • Saint Joseph Regional Medical Center
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160-7357
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
    • 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
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • CCOP - Metro-Minnesota
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216-4505
        • University of Mississippi Medical Center
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Kansas City, Missouri, Forenede Stater, 64131
        • CCOP - Kansas City
      • Springfield, Missouri, Forenede Stater, 65807
        • CCOP - Cancer Research for the Ozarks
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68106
        • CCOP - Missouri Valley Cancer Consortium
    • New York
      • Brooklyn, New York, Forenede Stater, 11203
        • SUNY Downstate Medical 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, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • Ireland Cancer Center
      • Cleveland, Ohio, Forenede Stater, 44124
        • Cleveland Clinic Taussig Cancer Center
      • Columbus, Ohio, Forenede Stater, 43222
        • Mount Carmel West Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73190
        • 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
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213-3180
        • 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
      • Temple, Texas, Forenede Stater, 76508
        • CCOP - Scott and White 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 endometrial carcinoma that is refractory to curative therapy or established treatment

    • Clinically and/or histologically confirmed persistent or recurrent disease

  • Measurable disease by physical examination or medical imaging

    • Sonography allowed if lesions are clearly defined on initial examination and bidimensionally measurable
    • Ascites or pleural effusions not considered measurable

  • Must have received 1 prior cytotoxic therapy regimen

    • May include high-dose therapy, consolidation, or extended therapy after surgical or nonsurgical assessment

    • 1 additional noncytotoxic regimen allowed

      • Biologic or cytostatic agents include, but are not limited to:

        • Monoclonal antibodies
        • Cytokines
        • Small-molecule inhibitors of signal transduction
  • Ineligible for a higher priority GOG protocol
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • GOG 0-2 if received 1 prior therapy regimen
  • GOG 0-1 if received 2 prior therapy regimens

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

Cardiovascular

  • No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Neurologic

  • No sensory or motor neuropathy greater than grade 1
  • No residual neuropathy attributed to prior chemotherapy or other chronic conditions (e.g., diabetes, venous stasis, or carpal tunnel syndrome)

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergy to platinum compounds or antiemetics
  • No active infection requiring antibiotics
  • No other uncontrolled illness
  • No other invasive malignancies within the past 5 years except nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • At least 14 days since prior pegfilgrastim
  • At least 24 hours since other prior growth factors
  • At least 3 weeks since prior biologic or immunologic therapy
  • No concurrent growth factors during first course of study therapy

Chemotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy and recovered
  • No more than 1 prior cytotoxic chemotherapy regimen, either single or combination cytotoxic drug therapy
  • No prior oxaliplatin

Endocrine therapy

  • At least 1 week since prior hormonal therapy directed at tumor
  • Concurrent hormone replacement therapy allowed

Radiotherapy

  • At least 4 weeks since prior radiotherapy and recovered

Surgery

  • Recovered from any recent surgery

Other

  • At least 3 weeks since prior therapy for endometrial cancer
  • No other concurrent investigational agents
  • No prior anticancer therapy that would preclude study participation

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: Paula M. Fracasso, MD, PhD, Washington University Siteman Cancer Center

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. november 1999

Studieafslutning (Faktiske)

1. september 2007

Datoer for studieregistrering

Først indsendt

4. november 2003

Først indsendt, der opfyldte QC-kriterier

5. november 2003

Først opslået (Skøn)

6. november 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juni 2013

Sidst verificeret

1. september 2004

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000068235
  • GOG-0129K

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 .

Abonner