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Paclitaxel and Cisplatin in Treating Patients With Stage III or Stage IV Ovarian Cancer or Primary Peritoneal Cancer

24. maj 2013 opdateret af: Gynecologic Oncology Group

A Phase III Randomized Trial of Cisplatin (NSC #119875) With Paclitaxel (NSC #125973) Administered by Either 24 Hour Infusion or 96 Hour Infusion in Patients With Selected Stage III and Stage IV Epithelial 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. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for ovarian or peritoneal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of paclitaxel plus cisplatin in treating patients who have residual disease after surgery to remove stage III or stage IV ovarian cancer or primary peritoneal cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES: I. Compare progression free and overall survival and frequency of response in patients with suboptimal stage III or IV ovarian epithelial cancer or primary peritoneal cancer treated with a 24 hour vs 96 hour infusion of paclitaxel (TAX) followed by cisplatin. II. Determine the incidence and severity of adverse events, including catheter complications and drug toxicity, for the 96 hour infusion of TAX. III. Compare the relationship between plasma TAX concentrations, toxicity, and response to both infusion schedules in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and measurable disease (yes vs no). Patients are randomized into one of two treatment arms. Arm I: Patients receive paclitaxel IV continuously over 24 hours followed by cisplatin IV over 2 hours. Arm II: Patients receive paclitaxel IV continuously over 96 hours followed by cisplatin IV over 2 hours. Treatment repeats every 3 weeks for 6 courses.

PROJECTED ACCRUAL: A total of 324 patients will be accrued for this study over 4.5 years.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

324

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Alabama
  - Birmingham, Alabama, Forenede Stater, 35294
    - University of Alabama Comprehensive Cancer Center
- 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
    - 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
- Indiana
  - Indianapolis, Indiana, Forenede Stater, 46202-5265
    - Indiana University Cancer Center
- Iowa
  - 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
- Massachusetts
  - 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
- Missouri
  - Kansas City, Missouri, Forenede Stater, 64131
    - CCOP - Kansas City
  - Saint Louis, Missouri, Forenede Stater, 63110
    - Washington University School of Medicine
- 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
  - New York, New York, Forenede Stater, 10021
    - Memorial Sloan-Kettering Cancer Center
  - Rochester, New York, Forenede Stater, 14642
    - University of Rochester Cancer Center
- 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
- 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, 19107
    - Pennsylvania Hospital
  - Philadelphia, Pennsylvania, Forenede Stater, 19104
    - University of Pennsylvania Cancer Center
  - Philadelphia, Pennsylvania, Forenede Stater, 19107
    - Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
- 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
- Texas
  - Dallas, Texas, Forenede Stater, 75235-9154
    - Simmons Cancer Center - Dallas
  - Houston, Texas, Forenede Stater, 77030
    - University of Texas - MD Anderson Cancer Center
- 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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

DISEASE CHARACTERISTICS: Histologically confirmed primary ovarian epithelial cancer or primary peritoneal cancer Suboptimal residual disease within 6 weeks of laparotomy with maximum resection Stage III residual retroperitoneal disease greater than 1 cm and no greater than 1 cm residual intraperitoneal disease OR Stage IV disease The following histologies are eligible: Serous adenocarcinoma Malignant Brenner's tumor Mucinous adenocarcinoma Endometrioid adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial carcinoma Transitional cell carcinoma Adenocarcinoma not otherwise specified Measurable disease not required Cytologic confirmation of malignant pleural effusion required if sole basis of entry No borderline (low malignant potential) carcinoma No unclassified ovarian cancer, i.e., thought to be of ovarian origin but unexplored or unable to verify tumor arising from ovarian stroma

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal AST, ALT, and GGT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal LDH no greater than 3 times normal No acute hepatitis Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No history of congestive heart failure No history of unstable angina No myocardial infarction within 6 months Other: No severe infection, including septicemia No severe gastrointestinal bleeding No history of second malignancy within 5 years except nonmelanomatous skin cancer Not pregnant or nursing Fertile patients must use effective contraception

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

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
Tildeling: Randomiseret

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)

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. marts 1996

Primær færdiggørelse (Faktiske)

1. oktober 2007

Datoer for studieregistrering

Først indsendt

1. november 1999

Først indsendt, der opfyldte QC-kriterier

21. juni 2004

Først opslået (Skøn)

22. juni 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. maj 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. maj 2013

Sidst verificeret

1. januar 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

CDR0000064554
GOG-0162

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 .