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

Cetuximab and Carboplatin in Treating Patients With Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

12. februar 2014 oppdatert av: Gynecologic Oncology Group

A Phase II Evaluation of Cetuximab (C225, NSC #714692) in Combination With Carboplatin (NSC #241240) in the Treatment of Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer

RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy such as carboplatin work in different ways to stop tumor cells from dividing so they stop growing or die. Combining cetuximab with carboplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with carboplatin works in treating patients with recurrent ovarian epithelial cancer or primary peritoneal cancer.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

  • Determine the antitumor activity of cetuximab and carboplatin in patients with recurrent platinum-sensitive ovarian epithelial or primary peritoneal cancer.
  • Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1, 8 , and 15. Patients also receive carboplatin IV after cetuximab administration on day 1. 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 20-65 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

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 1450
        • Australia New Zealand Gynaecological Oncology Trials Group
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre - Calgary
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35294
        • Comprehensive Cancer Center at University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, Forente stater, 85006-2726
        • CCOP - Western Regional, Arizona
    • California
      • Los Angeles, California, Forente stater, 90095-1740
        • Jonsson Comprehensive Cancer Center at UCLA
      • Los Gatos, California, Forente stater, 95032
        • Women's Cancer Center - Los Gatos
      • Orange, California, Forente stater, 92868
        • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
    • Colorado
      • Denver, Colorado, Forente stater, 80010
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center
    • Connecticut
      • New Haven, Connecticut, Forente stater, 06520-8028
        • Yale Comprehensive Cancer Center at Yale University School of Medicine
    • Delaware
      • Newark, Delaware, Forente stater, 19713
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20307-5001
        • Walter Reed Army Medical Center
    • Florida
      • Tampa, Florida, Forente stater, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96813
        • MBCCOP - Hawaii
    • Illinois
      • Chicago, Illinois, Forente stater, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, Forente stater, 60612
        • MBCCOP - University of Illinois at Chicago
      • Chicago, Illinois, Forente stater, 60612-3824
        • Rush University Medical Center
      • Decatur, Illinois, Forente stater, 62794-9640
        • CCOP - Central Illinois
      • Evanston, Illinois, Forente stater, 60201
        • CCOP - Evanston
      • Hinsdale, Illinois, Forente stater, 60521
      • Urbana, Illinois, Forente stater, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46202-5289
        • Indiana University Cancer Center
      • South Bend, Indiana, Forente stater, 46617
        • Saint Joseph Regional Medical Center
    • Iowa
      • Iowa City, Iowa, Forente stater, 52242-1002
        • Holden Comprehensive Cancer Center at University of Iowa
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40536-0084
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02111
        • TUFTS - New England Medical Center
      • Worcester, Massachusetts, Forente stater, 01605-2982
        • UMASS Memorial Cancer Center - University Campus
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Grand Rapids, Michigan, Forente stater, 49503
        • CCOP - Grand Rapids
      • Kalamazoo, Michigan, Forente stater, 49007-3731
        • CCOP - Kalamazoo
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55455
        • University of Minnesota Cancer Center
      • Rochester, Minnesota, Forente stater, 55905-0001
        • Mayo Clinic Cancer Center
      • Saint Louis Park, Minnesota, Forente stater, 55416
        • CCOP - Metro-Minnesota
    • Mississippi
      • Jackson, Mississippi, Forente stater, 39216-4505
        • University of Mississippi Medical Center
      • Keesler AFB, Mississippi, Forente stater, 39534-2576
        • Keesler Medical Center - Keesler Air Force Base
    • Missouri
      • Columbia, Missouri, Forente stater, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Kansas City, Missouri, Forente stater, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, Forente stater, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital
      • Springfield, Missouri, Forente stater, 65807
        • CCOP - Cancer Research for the Ozarks
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68106
        • CCOP - Missouri Valley Cancer Consortium
    • New Jersey
      • Camden, New Jersey, Forente stater, 08103-1489
        • Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
    • New York
      • Brooklyn, New York, Forente stater, 11203
        • SUNY Downstate Medical Center
      • Buffalo, New York, Forente stater, 14263-0001
        • Roswell Park Cancer Institute
      • Manhasset, New York, Forente stater, 11030
        • North Shore University Hospital
      • New York, New York, Forente stater, 10021
        • Memorial Sloan-Kettering Cancer Center
      • Stony Brook, New York, Forente stater, 11790-7775
        • Long Island Cancer Center at Stony Brook University Hospital
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27599-7570
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Durham, North Carolina, Forente stater, 27710
        • Duke Comprehensive Cancer Center
      • Greenville, North Carolina, Forente stater, 27858
        • Gynecologic Oncology Network
      • Winston-Salem, North Carolina, Forente stater, 27157-1065
        • Comprehensive Cancer Center at Wake Forest University
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45267-0520
        • Charles M. Barrett Cancer Center at University Hospital
      • Cleveland, Ohio, Forente stater, 44124
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, Forente stater, 44106
        • Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
      • Columbus, Ohio, Forente stater, 43210-1240
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • University of Oklahoma College of Medicine
    • Oregon
      • Portland, Oregon, Forente stater, 97225
        • CCOP - Columbia River Oncology Program
    • Pennsylvania
      • Abington, Pennsylvania, Forente stater, 19001-3788
        • Abington Memorial Hospital
      • Danville, Pennsylvania, Forente stater, 17822-2001
        • CCOP - Geisinger Clinic and Medical Center
      • Hershey, Pennsylvania, Forente stater, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, Forente stater, 19104-4283
        • Abramson Cancer Center of the University of Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19111
        • Fox Chase-Temple Cancer Center
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
      • Pittsburgh, Pennsylvania, Forente stater, 15213-3180
        • UPMC Cancer Center at Magee-Womens Hospital
    • Tennessee
      • Knoxville, Tennessee, Forente stater, 37917
        • Southeast Gynecologic Oncology Associates
      • Nashville, Tennessee, Forente stater, 37232-2516
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Dallas, Texas, Forente stater, 75390-9032
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
      • Galveston, Texas, Forente stater, 77555-0587
        • University of Texas Medical Branch
      • Houston, Texas, Forente stater, 77030-4009
        • M.D. Anderson Cancer Center at University of Texas
      • Temple, Texas, Forente stater, 76508
        • CCOP - Scott and White Hospital
    • Vermont
      • Burlington, Vermont, Forente stater, 05401
        • Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22908
        • University of Virginia Cancer Center
    • Washington
      • Seattle, Washington, Forente stater, 98109-1024
        • Fred Hutchinson Cancer Research Center
      • Tacoma, Washington, Forente stater, 98405
        • MultiCare Regional Cancer Center at Tacoma General Hospital
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53792-6188
        • University of Wisconsin Comprehensive Cancer Center
      • Marshfield, Wisconsin, Forente stater, 54449
        • CCOP - Marshfield Clinic Research Foundation
  • Japan
      • Kagoshima City, Japan, 892-8580
        • Kagoshima City Hospital
  • Norge
      • Oslo, Norge, N-0310
        • Norwegian Radium 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 ovarian epithelial or primary peritoneal cancer

    • Recurrent disease

  • Measurable disease

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR ≥ 10 mm by spiral CT scan
    • Target lesion not within previously irradiated field

  • Received 1 prior platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or other organoplatinum compound

    • Initial treatment may have included high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
    • Patients who had not received prior paclitaxel therapy may have received a second regimen that included paclitaxel

  • Platinum-sensitive disease

    • Treatment-free interval without clinical evidence of progressive disease for more than 6 months after response to a prior platinum-based regimen
    • If there is another concurrently active GOG-0146 series protocol (non-platinum-based therapy), must have had a treatment-free interval of more than 12 months unless ineligible for the other protocol* NOTE: *Applies whether or not both protocols are available at the same participating center
  • Must have available tissue block or unstained sections from primary tumor, interval debulking, or secondary debulking
  • Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No uncontrolled hypertension
  • No unstable angina
  • No congestive heart failure
  • No uncontrolled arrhythmias within the past 6 months
  • No other significant cardiac disease

Neurologic

  • No uncontrolled seizure disorder
  • No active neurological disease
  • No neuropathy > grade 1

Other

  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No active infection requiring antibiotics
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior anti-epidermal growth factor receptor (EGFR) antibody therapy
  • No prior chimerized or murine monoclonal antibody therapy
  • At least 3 weeks since prior biologic or immunologic therapy for the malignancy

Chemotherapy

  • See Disease Characteristics
  • Recovered from prior chemotherapy
  • No prior cytotoxic chemotherapy for recurrent disease, including retreatment with initial chemotherapy regimens

Endocrine therapy

  • At least 1 week since prior hormonal therapy for the malignancy
  • Concurrent hormone replacement therapy allowed

Radiotherapy

  • See Disease Characteristics
  • Recovered from prior radiotherapy
  • No prior radiotherapy to > 25% of bone marrow-bearing areas

Surgery

  • More than 30 days since prior major surgery and recovered

    • Diagnostic biopsy not considered major surgery

Other

  • At least 3 weeks since other prior therapy for the malignancy
  • No prior tyrosine kinase inhibitors that target the EGFR pathway
  • No prior cancer treatment that would preclude study treatment
  • No other concurrent investigational agents

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Masking: Ingen (Open Label)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Gynecologic Oncology Group

Samarbeidspartnere

Bristol-Myers Squibb
National Cancer Institute (NCI)

Etterforskere

  • Studiestol: Angeles A. Secord, MD, Duke Cancer Institute
  • Deborah K. Armstrong, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Nita Maihle, PhD, Yale University

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 2004

Primær fullføring (Faktiske)

1. april 2006

Datoer for studieregistrering

Først innsendt

8. juli 2004

Først innsendt som oppfylte QC-kriteriene

9. juli 2004

Først lagt ut (Anslag)

12. juli 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

14. februar 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. februar 2014

Sist bekreftet

1. februar 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • GOG-0146P
  • BMS-CA225-019
  • CDR0000371712

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