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Docetaxel in Treating Patients With Recurrent or Refractory Ovarian or Primary Peritoneal Cancer

10. april 2013 oppdatert av: Gynecologic Oncology Group

Evaluation of Docetaxel in Recurrent, Platinum Resistant, Refractory and Paclitaxel Refractory Ovarian Cancer and Primary Peritoneal Carcinoma

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 docetaxel in treating patients with recurrent or refractory ovarian or primary peritoneal cancer.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES: I. Estimate the antitumor activity of docetaxel in patients with paclitaxel- and platinum-resistant, recurrent or refractory, ovarian epithelial or primary peritoneal cancer who have failed on higher priority treatment protocols. II. Determine the nature and degree of toxicity of docetaxel in this patient population.

OUTLINE: Patients receive docetaxel as a 1 hour continuous intravenous infusion. Courses are repeated every 21 days. Treatment continues in the absence of unacceptable toxic effects or disease progression. All patients are followed every 3 months for 2 years, every 6 months for 3 years, and then until death.

PROJECTED ACCRUAL: A total of 23-56 patients will be accrued for this study.

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
    • Ontario
      • Kingston, Ontario, Canada, K7L 3N6
        • NCIC-Clinical Trials Group
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35294
        • University of Alabama Comprehensive Cancer Center
    • Arizona
      • Phoenix, Arizona, Forente stater, 85006-2726
        • CCOP - Greater Phoenix
    • California
      • Los Angeles, California, Forente stater, 90033-0800
        • USC/Norris Comprehensive Cancer Center
      • Los Angeles, California, Forente stater, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Orange, California, Forente stater, 92868
        • Chao Family Comprehensive Cancer Center
      • Palo Alto, California, Forente stater, 94304
        • Women's Cancer Center
    • Colorado
      • Denver, Colorado, Forente stater, 80262
        • University of Colorado Cancer Center
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20307-5000
        • Walter Reed Army Medical Center
      • Washington, District of Columbia, Forente stater, 20007
        • Vincent T. Lombardi Cancer Research Center, Georgetown University
    • Florida
      • Tampa, Florida, Forente stater, 33612
        • H. Lee Moffitt Cancer Center and Research Institute
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Emory University Hospital - Atlanta
      • Atlanta, Georgia, Forente stater, 30342-1701
        • CCOP - Atlanta Regional
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96813
        • MBCCOP - Hawaii
    • Illinois
      • Chicago, Illinois, Forente stater, 60612
        • Rush-Presbyterian-St. Luke's Medical Center
      • Chicago, Illinois, Forente stater, 60637
        • University of Chicago Cancer Research Center
      • Evanston, Illinois, Forente stater, 60201
        • CCOP - Evanston
      • Springfield, Illinois, Forente stater, 62526
        • CCOP - Central Illinois
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46202-5265
        • Indiana University Cancer Center
    • Iowa
      • Iowa City, Iowa, Forente stater, 52242
        • University of Iowa Hospitals and Clinics
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40536-0084
        • Albert B. Chandler Medical Center, University of Kentucky
    • Maryland
      • Baltimore, Maryland, Forente stater, 21287
        • Johns Hopkins Oncology Center
      • Bethesda, Maryland, Forente stater, 20892
        • Radiation Oncology Branch
      • Bethesda, Maryland, Forente stater, 20892
        • Medicine Branch
    • Massachusetts
      • Worcester, Massachusetts, Forente stater, 01655
        • University of Massachusetts Memorial Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48106
        • CCOP - Ann Arbor Regional
      • Detroit, Michigan, Forente stater, 48201
        • Barbara Ann Karmanos Cancer Institute
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55455
        • University of Minnesota Cancer Center
    • Mississippi
      • Jackson, Mississippi, Forente stater, 39216-4505
        • University of Mississippi Medical Center
      • Keesler AFB, Mississippi, Forente stater, 39534-2576
        • Keesler Medical Center - Keesler AFB
    • Missouri
      • Kansas City, Missouri, Forente stater, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, Forente stater, 63110
        • Washington University School of Medicine
    • Montana
      • Billings, Montana, Forente stater, 59101
        • CCOP - Montana Cancer Consortium
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68131
        • CCOP - Missouri Valley Cancer Consortium
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89106
        • CCOP - Southern Nevada Cancer Research Foundation
    • New Jersey
      • Camden, New Jersey, Forente stater, 08103
        • Cooper Hospital/University Medical Center
    • New York
      • Albany, New York, Forente stater, 12208
        • Cancer Center of Albany Medical Center
      • Brooklyn, New York, Forente stater, 11203
        • State University of New York Health Science Center at Brooklyn
      • Manhasset, New York, Forente stater, 11030
        • North Shore University Hospital
      • New York, New York, Forente stater, 10021
        • Memorial Sloan-Kettering Cancer Center
      • Rochester, New York, Forente stater, 14642
        • University of Rochester Cancer Center
      • Stony Brook, New York, Forente stater, 11790-9832
        • 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 of Wake Forest University Baptist Medical Center
      • Winston-Salem, North Carolina, Forente stater, 27103
        • Brookview Research, Inc.
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45219
        • Barrett Cancer Center, The University Hospital
      • Cleveland, Ohio, Forente stater, 44195
        • Cleveland Clinic Cancer Center
      • Cleveland, Ohio, Forente stater, 44106-5065
        • Ireland Cancer Center
      • Columbus, Ohio, Forente stater, 43210
        • Arthur G. James Cancer Hospital - Ohio State University
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73190
        • University of Oklahoma College of Medicine
      • Tulsa, Oklahoma, Forente stater, 74136
        • CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
    • Oregon
      • Portland, Oregon, Forente stater, 97213
        • CCOP - Columbia River Program
    • Pennsylvania
      • Abington, Pennsylvania, Forente stater, 19001
        • Abington Memorial Hospital
      • Hershey, Pennsylvania, Forente stater, 17033
        • Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, Forente stater, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Pennsylvania Hospital
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • University of Pennsylvania Cancer Center
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425-0721
        • Medical University of South Carolina
      • Spartanburg, South Carolina, Forente stater, 29303
        • CCOP - Upstate Carolina
    • Tennessee
      • Memphis, Tennessee, Forente stater, 38117
        • CCOP - Baptist Cancer Institute
    • Texas
      • Dallas, Texas, Forente stater, 75235-9154
        • Simmons Cancer Center - Dallas
      • Houston, Texas, Forente stater, 77030
        • University of Texas - MD Anderson Cancer Center
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22908
        • Cancer Center, University of Virginia HSC
    • Washington
      • Seattle, Washington, Forente stater, 98195-6043
        • University of Washington Medical Center
      • Tacoma, Washington, Forente stater, 98405
        • Tacoma General 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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory ovarian epithelial or peritoneal cancer Platinum resistant AND paclitaxel resistant Progressed on or within 6 months of completing therapy with paclitaxel and platinum either alone or in combination Bidimensionally measurable disease (excludes ascites and pleural effusions) Brain metastases allowed provided that other measurable disease exists and brain lesions required no therapy for 6 months and are not life threatening Not eligible for higher priority GOG protocol

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: At least 8 weeks 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/SGPT no greater than 1.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: No significant infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of allergic reaction to polysorbate 80 (e.g., etoposide or vitamin E) No other invasive malignancies within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Must have had at least 1 prior platinum based chemotherapeutic regimen containing carboplatin, cisplatin, or another organoplatinum compound Must have had at least 1 prior paclitaxel based chemotherapeutic regimen 1 or 2 prior chemotherapy regimens containing platinum and paclitaxel allowed Recovered from toxic effects No prior docetaxel Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Recovered from effects of recent surgery Other: At least 3 weeks since any prior therapy directed at the malignant tumor No prior cancer treatment that contraindicates this protocol therapy

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: Peter G. Rose, MD, The Cleveland Clinic

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. juni 1998

Primær fullføring (Faktiske)

1. april 2003

Datoer for studieregistrering

Først innsendt

10. desember 1999

Først innsendt som oppfylte QC-kriteriene

24. juni 2003

Først lagt ut (Anslag)

25. juni 2003

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. mai 2003

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CDR0000066369
  • GOG-126J

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