Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Capecitabine in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cavity Cancer

10. april 2013 oppdatert av: Gynecologic Oncology Group

Phase II Evaluation Of Capecitabine In Recurrent Platinum-Sensitive Ovarian Or Primary Peritoneal Cancer

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 capecitabine in treating patients who have recurrent ovarian epithelial or primary peritoneal cavity cancer.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

  • Determine the antitumor activity of capecitabine in patients with recurrent, platinum-sensitive ovarian epithelial or primary peritoneal cavity cancer.
  • Determine the nature and degree of toxicity of this drug in this patient population.

OUTLINE: This is a multicenter study.

Patients receive oral capecitabine twice daily for 14 days. Courses repeat every 21 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 22-60 patients will be accrued for this study within 6-12 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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Center - Calgary
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35294-3300
        • University of Alabama at Birmingham Comprehensive Cancer Center
    • California
      • Los Angeles, California, Forente stater, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Angeles, California, Forente stater, 90033-0804
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Orange, California, Forente stater, 92868
        • Chao Family Comprehensive Cancer Center
    • Colorado
      • Denver, Colorado, Forente stater, 80010
        • University of Colorado Cancer Center
    • Florida
      • Tampa, Florida, Forente stater, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute
    • Illinois
      • Chicago, Illinois, Forente stater, 60612
        • Rush-Presbyterian-St. Luke's Medical Center
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46202-5289
        • Indiana University Cancer Center
    • Iowa
      • Iowa City, Iowa, Forente stater, 52242-1009
        • Holden Comprehensive Cancer Center at the University of Iowa
    • Maryland
      • Bethesda, Maryland, Forente stater, 20892
        • Radiation Oncology Branch
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02111
        • Tufts University School of Medicine
      • Worcester, Massachusetts, Forente stater, 01655
        • University of Massachusetts Memorial Medical Center
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55455
        • University of Minnesota Cancer Center
      • Rochester, Minnesota, Forente stater, 55905
        • Mayo Clinic Cancer Center
    • Missouri
      • Columbia, Missouri, Forente stater, 65203
        • Ellis Fischel Cancer Center - Columbia
      • Saint Louis, Missouri, Forente stater, 63110
        • Washington University School of Medicine
    • New Jersey
      • Camden, New Jersey, Forente stater, 08103
        • Cooper Hospital/University Medical Center
    • New York
      • Brooklyn, New York, Forente stater, 11203
        • State University of New York Health Science Center at Brooklyn
      • New York, New York, Forente stater, 10021
        • Memorial Sloan-Kettering Cancer Center
      • Stony Brook, New York, Forente stater, 11790-7775
        • State University of New York Health Sciences Center - Stony Brook
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27599-7295
        • Lineberger Comprehensive Cancer Center, UNC
      • Durham, North Carolina, Forente stater, 27710
        • Duke Comprehensive Cancer Center
      • Winston-Salem, North Carolina, Forente stater, 27157-1082
        • Comprehensive Cancer Center at Wake Forest University
    • Ohio
      • Cleveland, Ohio, Forente stater, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Columbus, Ohio, Forente stater, 43210-1240
        • Arthur G. James Cancer Hospital - Ohio State University
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73190
        • University of Oklahoma College of Medicine
    • Pennsylvania
      • Abington, Pennsylvania, Forente stater, 19001
        • Abington Memorial Hospital
      • Hershey, Pennsylvania, Forente stater, 17033
        • Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, Forente stater, 19107-5541
        • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
    • Texas
      • Houston, Texas, Forente stater, 77030-4009
        • University of Texas - MD Anderson Cancer Center

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 proven recurrent ovarian epithelial or primary peritoneal cavity cancer

  • Measurable disease

    • At least 1 unidimensionally measurable lesion
    • Ascites and pleural effusions are not considered measurable disease

  • Prior therapy must include 1 platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or another organoplatinum compound

    • Treatment-free interval of 6-12 months after response to platinum therapy
  • Not eligible for higher priority GOG protocol

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least lower limit of normal

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 clearance at least 50 mL/min

Other:

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No neuropathy (sensory and motor) greater than grade 1
  • No other malignancy within the past 5 years except nonmelanoma skin cancer
  • No concurrent active infection requiring antibiotics

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 3 weeks since prior biologic or immunologic therapy
  • No concurrent prophylactic filgrastim (G-CSF)

Chemotherapy:

  • See Disease Characteristics
  • If no prior therapy with paclitaxel, a second regimen including paclitaxel allowed
  • No prior capecitabine or fluorouracil
  • No prior chemotherapy for recurrent or persistent disease, including pretreatment with initial chemotherapy regimens
  • Recovered from prior chemotherapy

Endocrine therapy:

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

Radiotherapy:

  • At least 3 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to site(s) of measurable disease
  • No prior radiotherapy to more than 25% of bone marrow

Surgery:

  • Recovered from prior surgery

Other:

  • No prior cancer treatment that would preclude study 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

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, University of Southern California

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. mars 2001

Primær fullføring (Faktiske)

1. juli 2005

Datoer for studieregistrering

Først innsendt

6. desember 2000

Først innsendt som oppfylte QC-kriteriene

16. mars 2004

Først lagt ut (Anslag)

17. mars 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

11. april 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. april 2013

Sist bekreftet

1. november 2005

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CDR0000068330
  • GOG-0146L

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