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Combination Chemotherapy in Treating Patients With Primary Peritoneal or Stage III Epithelial Ovarian Cancer

24. mai 2013 oppdatert av: Gynecologic Oncology Group

A Phase III Randomized Trial of Intravenous Paclitaxel and Cisplatin Versus Intravenous Paclitaxel, Intraperitoneal Cisplatin and Intraperitoneal Paclitaxel in Patients With Optimal Stage III Epithelial Ovarian Carcinoma or Primary Peritoneal Carcinoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known whether intravenous two-drug combination chemotherapy is more effective than intravenous and intraperitoneal infusions of three-drug combination chemotherapy for treating primary peritoneal or stage III epithelial ovarian cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of intravenous two-drug combination chemotherapy with intravenous and intraperitoneal three-drug combination chemotherapy in treating patients who have primary peritoneal or stage III epithelial ovarian cancer.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES: I. Compare pathological response, recurrence-free interval, and survival in patients with optimal stage III epithelial ovarian cancer or primary peritoneal carcinoma receiving intravenous (IV) paclitaxel and cisplatin vs IV paclitaxel and intraperitoneal (IP) cisplatin plus IP paclitaxel. II. Compare the toxic effects and complications of these 2 treatment regimens in these patients. III. Determine the frequency and prognostic significance of BRCA1 and BRCA2 mutations in these patients. IV. Determine the effect of non-genetic risk factors on the course of disease in BRCA1- and BRCA2-related ovarian cancer or primary peritoneal carcinoma. V. Compare the quality of life of these patients receiving these treatments.

OUTLINE: This is a randomized study. Patients are stratified according to gross residual disease (present vs absent) and whether second-look surgery will be performed at the end of treatment (yes vs no). Blood is drawn for BRCA mutation analysis and DNA extraction before the start of chemotherapy, but after randomization. Patients are randomized to one of two treatment arms. Patients in arm I receive IV paclitaxel by 24-hour infusion on day 1 followed by IV cisplatin on day 2. Patients in arm II receive IV paclitaxel by 24-hour infusion on day 1 followed by intraperitoneal (IP) cisplatin on day 2, plus IP paclitaxel on day 8. Treatment for both arms repeats every 3 weeks for a total of 6 treatment courses. Following chemotherapy, second look surgery is performed if selected by the patient. Quality-of-life assessments are performed prior to randomization, prior to course 4, 3-6 weeks after the completion of course 6 and prior to second look surgery if selected, 6 months after treatment is completed, and 12 months after treatment is completed. Patients are followed every 3 months for 2 years, then every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 384 patients will be accrued for this study within 16 months.

Studietype

Intervensjonell

Registrering (Forventet)

384

Fase

  • Fase 3

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
        • 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
        • Lombardi Cancer 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
      • Decatur, Illinois, Forente stater, 62526
        • CCOP - Central Illinois
      • Evanston, Illinois, Forente stater, 60201
        • CCOP - Evanston
    • 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, 21231
        • 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
    • 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
      • Livingston, New Jersey, Forente stater, 07039
        • St. Barnabas Medical Center
      • Morristown, New Jersey, Forente stater, 07962-1956
        • Morristown Memorial Hospital
    • 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, 11790-7775
        • 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 of Wake Forest University Baptist Medical Center
    • 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 - Sooner State
    • 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, 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
      • Nashville, Tennessee, Forente stater, 37203
        • Brookview Research, Inc.
    • 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

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

DISEASE CHARACTERISTICS: Histologically proven primary peritoneal carcinoma or optimal (no greater than 1 cm residual disease) stage III epithelial ovarian carcinoma with the following epithelial cell types: Serous adenocarcinoma Endometrioid adenocarcinoma Mucinous adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial carcinoma Transitional cell carcinoma Malignant Brenner's Tumor Adenocarcinoma NOS Prior surgery for ovarian/peritoneal carcinoma required No epithelial ovarian carcinoma of low malignant potential (borderline carcinoma)

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 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal No acute hepatitis Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No unstable angina No myocardial infarction within prior 6 months Patients with abnormal cardiac conduction are eligible if disease stable for at least 6 months Other: No septicemia or severe infection No severe gastrointestinal bleeding No other invasive malignancy within past 5 years except nonmelanoma skin cancer Any previous cancer treatment must not contraindicate this protocol therapy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics No more than 6 weeks since prior surgery

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert

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)

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 1998

Primær fullføring (Faktiske)

1. januar 2006

Datoer for studieregistrering

Først innsendt

1. november 1999

Først innsendt som oppfylte QC-kriteriene

20. mai 2004

Først lagt ut (Anslag)

21. mai 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

27. mai 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. mai 2013

Sist bekreftet

1. august 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CDR0000066273
  • GOG-0172

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. .

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