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Oxaliplatin in Treating Patients With Recurrent or Refractory Cervical Cancer

20. juni 2013 opdateret af: Gynecologic Oncology Group

Phase II Evaluation of Oxaliplatin in Persistent or Recurrent Squamous Cell Carcinoma of the Cervix

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 oxaliplatin in treating patients who have recurrent or refractory cervical cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES: I. Determine the antitumor activity of oxaliplatin by measuring response rate in patients with recurrent or refractory squamous cell carcinoma of the cervix who have failed on higher priority treatment protocols. II. Determine the nature and degree of toxicity of this drug in this patient population.

OUTLINE: Patients receive oxaliplatin IV over 2 hours. Treatment continues every 21 days for a maximum of 9 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 12-14 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

  • 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
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85006-2726
        • CCOP - Greater Phoenix
    • California
      • Los Angeles, California, Forenede Stater, 90033-0800
        • USC/Norris Comprehensive Cancer Center
      • Los Angeles, California, Forenede Stater, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Orange, California, Forenede Stater, 92868
        • Chao Family Comprehensive Cancer Center
      • Palo Alto, California, Forenede Stater, 94304
        • Women's Cancer Center
    • Colorado
      • Denver, Colorado, Forenede Stater, 80262
        • University of Colorado Cancer Center
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20307-5000
        • Walter Reed Army Medical Center
      • Washington, District of Columbia, Forenede Stater, 20007
        • Vincent T. Lombardi Cancer Research Center, Georgetown University
    • Florida
      • Tampa, Florida, Forenede Stater, 33612
        • H. Lee Moffitt Cancer Center and Research Institute
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Emory University Hospital - Atlanta
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96813
        • MBCCOP - Hawaii
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612-7323
        • MBCCOP - University of Illinois at Chicago
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush-Presbyterian-St. Luke's Medical Center
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago Cancer Research Center
      • Decatur, Illinois, Forenede Stater, 62526
        • CCOP - Central Illinois
      • Evanston, Illinois, Forenede Stater, 60201
        • CCOP - Evanston
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202-5265
        • Indiana University Cancer Center
    • Iowa
      • Des Moines, Iowa, Forenede Stater, 50309-1016
        • CCOP - Iowa Oncology Research Association
      • Iowa City, Iowa, Forenede Stater, 52242
        • University of Iowa Hospitals and Clinics
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536-0084
        • Albert B. Chandler Medical Center, University of Kentucky
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins Oncology Center
      • Bethesda, Maryland, Forenede Stater, 20892
        • Radiation Oncology Branch
      • Bethesda, Maryland, Forenede Stater, 20892
        • Medicine Branch
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02111
        • Tufts University School of Medicine
      • Worcester, Massachusetts, Forenede Stater, 01655
        • University of Massachusetts Memorial Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48106
        • CCOP - Ann Arbor Regional
      • 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
      • Keesler AFB, Mississippi, Forenede Stater, 39534-2576
        • Keesler Medical Center - Keesler AFB
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65203
        • Ellis Fischel Cancer Center
      • Kansas City, Missouri, Forenede Stater, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
      • Springfield, Missouri, Forenede Stater, 65807
        • CCOP - Cancer Research for the Ozarks
    • Montana
      • Billings, Montana, Forenede Stater, 59101
        • CCOP - Montana Cancer Consortium
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68131
        • CCOP - Missouri Valley Cancer Consortium
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89106
        • CCOP - Southern Nevada Cancer Research Foundation
    • New Jersey
      • Camden, New Jersey, Forenede Stater, 08103
        • Cooper Hospital/University Medical Center
    • 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
      • New York, New York, Forenede Stater, 10021
        • Memorial Sloan-Kettering Cancer Center
      • Rochester, New York, Forenede Stater, 14642
        • University of Rochester Cancer Center
      • 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 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
    • Oregon
      • Portland, Oregon, Forenede Stater, 97213
        • CCOP - Columbia River Program
    • 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
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
      • Wynnewood, Pennsylvania, Forenede Stater, 19096
        • CCOP - MainLine Health
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425-0721
        • Medical University of 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
      • Houston, Texas, Forenede Stater, 77030
        • University of Texas - MD Anderson Cancer Center
      • Temple, Texas, Forenede Stater, 76508
        • CCOP - Scott and White Hospital
    • 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 confirmed refractory or recurrent squamous cell carcinoma of the cervix that has failed local therapeutic measures and considered incurable Bidimensionally measurable disease Must not be eligible for a higher priority GOG protocol No known brain metastases

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 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 normal Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: Not pregnant or nursing Fertile patients must use effective contraception No evidence of preexisting peripheral sensory neuropathy greater than CTC grade 1, including residual neuropathy attributed to prior chemotherapy and other chronic conditions (e.g., diabetes, venous stasis, and carpal tunnel syndrome) No history of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol directed chemotherapy No other uncontrolled concurrent illness (e.g., ongoing or active infection) No other malignancy within the past 5 years except nonmelanoma skin cancer and no other prior malignancy whose prior cancer treatment contraindicates this protocol therapy

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factors (CSFs) during first course of therapy At least 24 hours since prior CSFs during subsequent courses of therapy Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No prior oxaliplatin No more than 1 prior chemotherapy regimen Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: At least 3 weeks since prior surgery and recovered Other: At least 3 weeks since prior anticancer therapy and recovered No other concurrent investigational agents No concurrent antiretroviral therapy (HAART)

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)

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. februar 2000

Studieafslutning (Faktiske)

1. juni 2004

Datoer for studieregistrering

Først indsendt

2. juni 2000

Først indsendt, der opfyldte QC-kriterier

2. maj 2003

Først opslået (Skøn)

5. maj 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juni 2013

Sidst verificeret

1. juli 2004

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000067852
  • GOG-127P

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 Livmoderhalskræft

Kliniske forsøg med oxaliplatin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in United States

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner