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Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine

15. oktober 2008 opdateret af: Pfizer

Phase II Trial of Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine

The purpose of this phase II, randomized, open-label clinical trial is to study 2 schedules of single-agent Irinotecan in women with metastatic breast cancer who have experienced failure of prior therapy with an anthracycline, a taxane, and capecitabine. Patients will receive Irinotecan capsules either once each day for 5 days, or once a day for 14 days in 3 week cycles.

Studieoversigt

Status

Afsluttet

Betingelser

Brystneoplasmer

Intervention / Behandling

Medicin: Irinotecan

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

134

Fase

Fase 2

Kontakter og lokationer

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

Studiesteder

Argentina
- - Capital Federal, Argentina, 1406
    - Pfizer Investigational Site
  - Cordoba, Argentina, 5000
    - Pfizer Investigational Site
  - Santa Fe, Argentina, 3000
    - Pfizer Investigational Site
- Buenos Aires
  - Capital Federal, Buenos Aires, Argentina, 1426
    - Pfizer Investigational Site
- Santa Fe
  - Rosario, Santa Fe, Argentina, 2000
    - Pfizer Investigational Site
Australien
- Queensland
  - South Brisbane, Queensland, Australien, 4101
    - Pfizer Investigational Site
- Victoria
  - Frankston, Victoria, Australien, 3199
    - Pfizer Investigational Site
Colombia
- Bogota DC
  - Bogota, Bogota DC, Colombia, 464
    - Pfizer Investigational Site
Forenede Stater
- Alabama
  - Mobile, Alabama, Forenede Stater, 36608
    - Pfizer Investigational Site
- Alaska
  - Anchorage, Alaska, Forenede Stater, 99508
    - Pfizer Investigational Site
- Idaho
  - Lewistown, Idaho, Forenede Stater, 83501
    - Pfizer Investigational Site
- Illinois
  - Alton, Illinois, Forenede Stater, 62002
    - Pfizer Investigational Site
- Indiana
  - Indianapolis, Indiana, Forenede Stater, 46227
    - Pfizer Investigational Site
- Kansas
  - Overland Park, Kansas, Forenede Stater, 66210
    - Pfizer Investigational Site
- Louisiana
  - Chalmette, Louisiana, Forenede Stater, 70043
    - Pfizer Investigational Site
  - Covington, Louisiana, Forenede Stater, 70433
    - Pfizer Investigational Site
  - Mandeville, Louisiana, Forenede Stater, 70448
    - Pfizer Investigational Site
  - Metairie, Louisiana, Forenede Stater, 70006
    - Pfizer Investigational Site
  - Metairie, Louisiana, Forenede Stater, 70002
    - Pfizer Investigational Site
  - New Orleans, Louisiana, Forenede Stater, 70115
    - Pfizer Investigational Site
- Massachusetts
  - Boston, Massachusetts, Forenede Stater, 02114
    - Pfizer Investigational Site
  - Boston, Massachusetts, Forenede Stater, 02115
    - Pfizer Investigational Site
  - Boston, Massachusetts, Forenede Stater, 02130
    - Pfizer Investigational Site
- Michigan
  - Detroit, Michigan, Forenede Stater, 48201
    - Pfizer Investigational Site
- Mississippi
  - Southaven, Mississippi, Forenede Stater, 38671
    - Pfizer Investigational Site
- Missouri
  - Kansas City, Missouri, Forenede Stater, 64111
    - Pfizer Investigational Site
  - St. Louis, Missouri, Forenede Stater, 63141
    - Pfizer Investigational Site
  - St. Louis, Missouri, Forenede Stater, 63136
    - Pfizer Investigational Site
  - Washington, Missouri, Forenede Stater, 63090
    - Pfizer Investigational Site
- New Jersey
  - New Brunswick, New Jersey, Forenede Stater, 08903
    - Pfizer Investigational Site
  - New Brunswick, New Jersey, Forenede Stater, 08901-2601
    - Pfizer Investigational Site
- New York
  - New York, New York, Forenede Stater, 10021
    - Pfizer Investigational Site
  - Stony Brook, New York, Forenede Stater, 11794
    - Pfizer Investigational Site
- Ohio
  - Kettering, Ohio, Forenede Stater, 45409
    - Pfizer Investigational Site
- Oklahoma
  - Oklahoma City, Oklahoma, Forenede Stater, 73120
    - Pfizer Investigational Site
- South Carolina
  - Greenville, South Carolina, Forenede Stater, 29615
    - Pfizer Investigational Site
- Tennessee
  - Covington, Tennessee, Forenede Stater, 38019
    - Pfizer Investigational Site
  - Franklin, Tennessee, Forenede Stater, 37067
    - Pfizer Investigational Site
  - Gallatin, Tennessee, Forenede Stater, 37066
    - Pfizer Investigational Site
  - Hermitage, Tennessee, Forenede Stater, 37076
    - Pfizer Investigational Site
  - Lebanon, Tennessee, Forenede Stater, 37087
    - Pfizer Investigational Site
  - Memphis, Tennessee, Forenede Stater, 38120
    - Pfizer Investigational Site
  - Murfreesboro, Tennessee, Forenede Stater, 37130
    - Pfizer Investigational Site
  - Nashville, Tennessee, Forenede Stater, 37203
    - Pfizer Investigational Site
  - Nashville, Tennessee, Forenede Stater, 37205
    - Pfizer Investigational Site
  - Nashville, Tennessee, Forenede Stater, 37207
    - Pfizer Investigational Site
  - Nashville, Tennessee, Forenede Stater, 37211
    - Pfizer Investigational Site
- Texas
  - Dallas, Texas, Forenede Stater, 75231
    - Pfizer Investigational Site
  - Dallas, Texas, Forenede Stater, 75230-2510
    - Pfizer Investigational Site
  - Dallas, Texas, Forenede Stater, 75204
    - Pfizer Investigational Site
  - Dallas, Texas, Forenede Stater, 75246
    - Pfizer Investigational Site
  - Fort Worth, Texas, Forenede Stater, 76104
    - Pfizer Investigational Site
  - Plano, Texas, Forenede Stater, 75075-7787
    - Pfizer Investigational Site
  - Tyler, Texas, Forenede Stater, 75702
    - Pfizer Investigational Site
- Washington
  - Federal Way, Washington, Forenede Stater, 98003
    - Pfizer Investigational Site
  - Lakewood, Washington, Forenede Stater, 98499
    - Pfizer Investigational Site
  - Seattle, Washington, Forenede Stater, 98104
    - Pfizer Investigational Site
  - Seattle, Washington, Forenede Stater, 98122
    - Pfizer Investigational Site
  - Seattle, Washington, Forenede Stater, 98195
    - Pfizer Investigational Site
  - Seattle, Washington, Forenede Stater, 98104-2499
    - Pfizer Investigational Site
  - Seattle, Washington, Forenede Stater, 98109-1023
    - Pfizer Investigational Site
  - Tacoma, Washington, Forenede Stater, 98405
    - Pfizer Investigational Site
  - Vancouver, Washington, Forenede Stater, 98684
    - Pfizer Investigational Site
  - Yakima, Washington, Forenede Stater, 98902
    - Pfizer Investigational Site
- Wisconsin
  - Milwaukee, Wisconsin, Forenede Stater, 53215
    - Pfizer Investigational Site
New Zealand
- - Wellington, New Zealand, 489
    - Pfizer Investigational Site

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

Inclusion Criteria:

Women with diagnosis of primary adenocarcinoma of the breast
Presence of locally advanced or metastatic disease non-amenable to surgery or radiation therapy with curative intent
At least one measurable lesion >20mm (or >10 mm with spiral CT scan)
Must have received (and failed) prior treatment with an anthracycline, a taxane, and capecitabine in the adjuvant and/or advanced disease treatment setting
Women at least 18 years old, with performance status 0-2

Exclusion Criteria:

Prior treatment with another topoisomerase I inhibitor
Current enrollment in another clinical trial

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
Interventionel model: Parallel tildeling
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
To evaluate the safety and efficacy of Irinotecan in refractory breast cancer.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

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.

Hjælpsomme links

To obtain contact information for a study center near you, click here.

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. november 2003

Primær færdiggørelse (Faktiske)

1. maj 2007

Studieafslutning (Faktiske)

1. maj 2007

Datoer for studieregistrering

Først indsendt

11. november 2003

Først indsendt, der opfyldte QC-kriterier

12. november 2003

Først opslået (Skøn)

13. november 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. oktober 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. oktober 2008

Sidst verificeret

1. oktober 2008

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

CPTAPO-0047-146
A5961023

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 .