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Epirubicin, Docetaxel, and Capecitabine in Treating Women With Stage IIIA or Stage IIIB Breast Cancer

13. maj 2011 opdateret af: Mayo Clinic

A Neo-Adjuvant Study of Sequential Epirubicin and Docetaxel in Combination With Capecitabine in Patients With Locally Advanced Breast Cancer

RATIONALE: Drugs used in chemotherapy, such as epirubicin, docetaxel, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving epirubicin together with docetaxel and capecitabine and to see how well it works in treating women with stage IIIA or stage IIIB breast cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • Describe the pathologic response rate in chemotherapy-naive women with locally advanced breast cancer (stage IIIA or IIIB) after 6 courses of sequential neoadjuvant therapy with epirubicin hydrochloride and a combination of docetaxel with capecitabine .
  • Describe the adverse events of sequential epirubicin hydrochloride and a combination of docetaxel with capecitabine in this patient population.

Secondary

  • Identify by transcriptional profiling the differential expression of candidate gene products that confer chemosensitivity to epirubicin hydrochloride, docetaxel, and capecitabine.
  • Correlate the differential expression of known genetic polymorphisms of intracellular regulators involved in the metabolism of epirubicin hydrochloride, docetaxel, and capecitabine with adverse events and tumor response.
  • Assess individual patient variation in clinical (toxicity and/or activity), in pharmacologic (pharmacokinetic/pharmacodynamic parameters), and/or biologic (correlative laboratory study results) responses to epirubicin hydrochloride, docetaxel, and capecitabine due to genetic differences in proteins involved in drug response (transport, metabolism and/or mechanism of action).

OUTLINE: Patients receive epirubicin hydrochloride IV on day 1. Treatment repeats every 2 weeks for 3 courses. Beginning 2 weeks after last dose of epirubicin hydrochloride, patients receive docetaxel IV over 1 hour on day 1 and oral capecitabine twice daily on days 1-14. Treatment with docetaxel and capecitabine repeats every 3 weeks for 3 courses. Patients then undergo surgery.

Blood samples are collected at baseline for pharmacogenetic studies. Tumor tissue samples are collected at baseline and periodically during treatment for correlative laboratory studies.

After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

47

Fase

  • Fase 2

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 or cytologically confirmed breast cancer

    • Stage IIIA or IIIB disease (T3 N1 M0, T4 N1 M0, any T N2/N3 M0)
  • Bidimensionally measurable or evaluable disease
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • ECOG performance status 0-2
  • Platelet count ≥ 100,000 cells/μL
  • Total bilirubin normal
  • Hemoglobin ≥ 8.0 g/dL
  • ANC ≥ 1,000 cells/μL
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Creatinine clearance ≥ 50 mL/min and serum creatinine normal
  • Life expectancy ≥ 3 months
  • No uncontrolled infection
  • No chronic debilitating disease
  • No lack of physical integrity of the upper gastrointestinal tract
  • Able to swallow tablets
  • No malabsorption syndrome
  • No clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias [New York Heart Association class III-IV heart disease] or myocardial infarction within the last 12 months)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer or adequately treated other noninvasive carcinomas
  • No peripheral neuropathy ≥ grade 1

PRIOR CONCURRENT THERAPY:

  • More than 4 weeks since prior major surgery and recovered
  • No prior chemotherapy regimens including adjuvant therapy
  • No organ allograft
  • No concurrent sorivudine or bruvidine
  • No other concurrent cytostatic, cytotoxic, immunomodulating agents, or radiotherapy

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
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Pathologic response rate
Toxicity patterns

Sekundære resultatmål

Resultatmål
Samlet overlevelse

Samarbejdspartnere og efterforskere

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

Sponsor

Mayo Clinic

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: James N. Ingle, MD, Mayo Clinic
  • Studiestol: Julian R. Molina, MD, PhD, Mayo Clinic
  • Ledende efterforsker: Wilma Lingle, PhD, Mayo Clinic

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. april 2003

Primær færdiggørelse (Faktiske)

1. marts 2006

Studieafslutning (Faktiske)

1. marts 2006

Datoer for studieregistrering

Først indsendt

27. marts 2008

Først indsendt, der opfyldte QC-kriterier

27. marts 2008

Først opslået (Skøn)

28. marts 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. maj 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. maj 2011

Sidst verificeret

1. maj 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000582618
  • P30CA015083 (U.S. NIH-bevilling/kontrakt)
  • MC0132 (Anden identifikator: Mayo Clinic Cancer Center)
  • 595-02 (Anden identifikator: Mayo Clinic IRB)
  • 378-ONC-0030-241 (Anden identifikator: Pharmacia Protocol)

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 .

Kliniske forsøg med Brystkræft

Kliniske forsøg med docetaxel

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Betingelser

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