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Paricalcitol and Chemotherapy in Treating Women With Metastatic Breast Cancer

25. maj 2017 opdateret af: Wake Forest University Health Sciences

Feasibility of Dose Titrating Paricalcitol (Zemplar) in Women Receiving Taxanes or Ixabepilone for Metastatic Breast Cancer

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, docetaxel,, paclitaxel, and ixabepilone work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Paricalcitol may help chemotherapy drugs to kill more tumor cells by making tumor cells more sensitive to the drugs.

PURPOSE: This clinical trial is studying the best dose and best way to give paricalcitol and to see how well it works when given together with chemotherapy in treating patients with metastatic breast cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • To determine the ability to administer 8 continuous weeks of therapy within the first 3 months of enrollment with paricalcitol when given together with taxane or ixabepilone therapy in women with metastatic breast cancer.
  • To estimate the proportion of patients who successfully complete 8 continuous weeks of therapy as well as the proportion of patients who achieve a 'steady-state' dose.

Secondary

  • To determine a dose of paricalcitol that can be taken continuously that maintains a normal calcium level when combined with a taxane or ixabepilone.
  • To determine if baseline levels of 25-hydroxycholecalciferol and parathyroid hormone (PTH) are associated with time to treatment failure in these patients.
  • To determine if PTH levels decline from baseline in patients treated with paricalcitol in combination with taxane or ixabepilone therapy.

OUTLINE: Beginning on day 1, patients receive oral paricalcitol. The dose of paricalcitol is increased every 2 weeks until the serum calcium level is between 9 mg/dL and 11.4 mg/dL. Once this level is reached, the patient continues at that dose for the duration of the study. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation, docetaxel, or paclitaxel once a week or once every 3 weeks or ixabepilone once every 3 weeks. Treatment continues for at least 12 weeks in the absence of disease progression or unacceptable toxicity.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

24

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27157-1096
        • Wake Forest University Comprehensive Cancer Center

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 til 120 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria

  • Histologically confirmed invasive breast cancer

    • Metastatic or recurrent disease
    • Patients with bone metastasis only are eligible and evaluable for time to progression
  • Candidate for taxane or ixabepilone therapy
  • At least one lesion that can be measured in at least one diameter ≥ 2 cm by CT scan
  • No symptomatic brain metastases or other symptomatic CNS metastases
  • ECOG performance status 0 or 1
  • Life expectancy > 3 months
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Serum creatinine ≤ 2.0 mg/dL
  • Total bilirubin ≤ 2.0 g/dL
  • Albumin corrected serum calcium < 10.5 mg/dL
  • Fertile patients must use effective contraception during and for at least 1 year after study participation
  • At least 2 weeks since prior chemotherapy or radiation therapy
  • Prior and concurrent taxane or ixabepilone therapy allowed
  • Concurrent oral multivitamins allowed (i.e., Centrum or One a Day)
  • Concurrent bisphosphonates allowed

Exclusion Criteria

  • History of allergy to calcitriol, paricalcitol, or other Vitamin D compounds
  • History of drug or alcohol abuse within the past 6 months
  • History of other malignancy except inactive nonmelanoma skin cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or other cancer if the patient has been disease-free for 5 or more years
  • Serious medical illness that would limit survival to < 3 months
  • Active, uncontrolled bacterial, viral or fungal infection
  • Poorly controlled diabetes
  • Concurrent supplemental calcium
  • Concurrent digitalis compounds
  • Concurrent chemotherapy
  • Concurrent biologic therapy, including trastuzumab and bevacizumab
  • Concurrent hormonal agents for breast cancer except luteinizing hormone-releasing hormone agonists

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Paricalcitol (Zemplar)
Medicin: docetaxel
Medicin: paclitaxel
Medicin: paclitaxel albumin-stabiliseret nanopartikelformulering
Medicin: ixabepilone
Medicin: paricalcitol

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical feasibility of therapy administration
Tidsramme: Baseline to 8 weeks
To test the clinical/logistical feasibility of using a titrated dose of the vitamin D analog (paracalcitol or Zemplar) in combination with a taxane or ixabepilone primarily by measuring the proportion of patients who successfully complete 8 continuous weeks of therapy as well as the proportion of patients who achieve a 'steady-state' dose
Baseline to 8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dose of paricalcitol that maintains a normal calcium level when given in combination with a taxane or ixabepilone
Tidsramme: Baseline to 8 weeks
Baseline to 8 weeks
Correlation of baseline levels of 25-hydroxycholecalciferol and parathyroid hormone with time to treatment failure
Tidsramme: Baseline to 8 weeks
To determine if baseline levels of 25(OH)D and parathyroid hormone are associated with time to treatment failure in patients treated with the combination of paricalcitol and a taxane or ixabepilone
Baseline to 8 weeks
Measurement of effect of combination of paricalcitol and a taxane or ixabepilone on parathyroid hormone levels failure
Tidsramme: Baseline to 8 weeks
To determine if parathyroid hormone levels decline from baseline with the combination of paricalcitol and a taxane or ixabepilone
Baseline to 8 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Wake Forest University Health Sciences

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Studiestol: Julia A. Lawrence, Wake Forest University Health Sciences
  • Ledende efterforsker: Susan A. Melin, MD, Wake Forest University Health Sciences

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 2008

Primær færdiggørelse (Faktiske)

1. november 2011

Studieafslutning (Faktiske)

1. marts 2013

Datoer for studieregistrering

Først indsendt

17. marts 2008

Først indsendt, der opfyldte QC-kriterier

17. marts 2008

Først opslået (Skøn)

18. marts 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. maj 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. maj 2017

Sidst verificeret

1. oktober 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000583652
  • P30CA012197 (U.S. NIH-bevilling/kontrakt)
  • CCCWFU-74307 (Anden identifikator: Comprehensive Cancer Center of WFUHS)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Brystkræft

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Sponsorer og samarbejdspartnere

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