- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02502864
Multicenter Study of Pharmacokinetic-Guided Docetaxel in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide
9. september 2020 opdateret af: H. Lee Moffitt Cancer Center and Research Institute
Multicenter Study Investigating Utilization of Pharmacokinetic(PK)-Guided Docetaxel in Senior Adult Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy
The purpose of this study is to adjust the amount of docetaxel participants receive based on the level of docetaxel measured in their blood.
This method of dose adjustment is called pharmacokinetic (PK)-adjusted docetaxel.
The researchers believe that adjusting the dose of docetaxel using this method will lessen the side effects associated with docetaxel in cancer treatment.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
9
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Florida
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Tampa, Florida, Forenede Stater, 33612
- H. Lee Moffitt Cancer Center and Research Institute
-
-
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
65 år og ældre (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Must have histologically confirmed localized or locally advanced breast cancer for which the treatment plan includes chemotherapy with 4 cycles of standard TC (docetaxel 75 mg/m^2 and cyclophosphamide 600mg/m^2)
- Age >/= 65 years (Senior adult focused study given increased risk for toxicity)
- Participants must be female
- Eastern Cooperative Oncology Group (ECOG) performance status <2
- Must have normal organ and marrow function
- No pre-existing neuropathy grade > 1 per the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0
- Be postmenopausal (defined as amenorrheic for at least 12 months)
- Must be informed of the investigational nature of this study and be willing to provide written informed consent in accordance with Institutional guidelines and Good Clinical Practice (GCP) indicating that they understand the purpose of and procedures required for the study and are willing to participate prior to the beginning of any specific study procedures.
Exclusion Criteria:
- Have uncontrolled illness (including, but not limited to, ongoing or active infection, congestive heart failure, angina pectoris, or cardiac arrhythmia) that would limit compliance with study requirements
- Have psychiatric illness that would limit compliance with study requirements
- Have history of allergic reactions attributed to compounds of similar chemical or biologic composition to taxanes (docetaxel or paclitaxel) or cyclophosphamide
- Have known seropositivity for human immunodeficiency virus, hepatitis C virus, hepatitis B surface antigen, or syphilis. Does not require serologic confirmation as a study procedure.
- Not willing to follow protocol requirements or to give informed consent
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: Standard of Care + Surveys
Standard of Care Docetaxel and Cyclophosphamide (TC) Chemotherapy + Surveys.
TC Regimen with Function Assessment of Cancer Therapy (FACT) Surveys.
All participants will receive TC for cycle 1 with subsequent cycles repeated every 3 weeks for a total of 4 cycles.
All initial dosing will be based on actual body weight and height.
Participants will receive up to 4 doses of chemotherapy.
Following their 4th dose of chemotherapy, or the last dose of chemotherapy in which blood level monitoring was performed, participants will be assessed for side effects from the chemotherapy and complete their final written 53 question survey about their quality of life.
|
Pharmacokinetic(PK)-guided docetaxel.
Cycle 1: 75 mg/m^2, intravenously (IV) on Day 1 for 60 minutes.
Beginning with cycle 2, the docetaxel dose will be individually adjusted before each cycle.
Andre navne:
Cycle 1: 600 mg/m^2, via IV on Day 1 for 30 minutes.
The cyclophosphamide dose will not be changed unless dictated by toxicity.
Andre navne:
Participants will complete the FACT-Taxane and FACT-Breast quality of life assessment written surveys at baseline, during each chemotherapy cycle, and 3-5 weeks following the last cycle in which PK monitoring was performed.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Rate of Achieving Targeted Area Under the Curve (AUC)
Tidsramme: Cycle 4 - Up to 6 months
|
Rate of PK guided dosing of docetaxel chemotherapy improving the ability to achieve a targeted AUC ( 2.5-3.7 mg*hr/L) within 4 cycles of therapy in patients > 65 years of age with breast cancer receiving TC (docetaxel and cyclophosphamide) as compared with historical non-PK guided therapy from patients receiving a similar regimen.
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Cycle 4 - Up to 6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Incidence of Grade 3 and 4 Neutropenia and Febrile Neutropenia
Tidsramme: Up to 6 months
|
The incidence of grade 3 and 4 neutropenia and febrile neutropenia in cycles following PK adjustment (cycles 2-4) will be compared with cycle 1 and historical non-PK guided therapy using the Wilcoxon-Rank sum assessment.
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Up to 6 months
|
Association Between Scores - Chemotherapy Risk Assessment Scale for High-Age Patients
Tidsramme: Baseline and Post Cycle 1
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The Chemotherapy Risk Assessment Scale for High-Age Patients (CRASH) score will be reported as ordinal data (low, intermediate-low, intermediate-high, or high risk).
|
Baseline and Post Cycle 1
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Association Between Scores - Instrumental Activities of Daily Living
Tidsramme: Baseline and Post Cycle 1
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The Instrumental Activities of Daily Living (IADL) total score will be reported as binomial data (greater or less than 26 based on how it is incorporated into the CRASH score).
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Baseline and Post Cycle 1
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Association Between Scores - Cumulative Illness Rating Scale for Geriatrics
Tidsramme: Baseline and Post Cycle 1
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The Cumulative Illness Rating Scale for Geriatrics (CIRS-G) will be reported as discrete data out of a possible score of 65.
The Wilcoxon-Rank sum and Chi-squared tests will be used as appropriate.
|
Baseline and Post Cycle 1
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Comparison of Patient Profiles and Function Assessment of Cancer Therapy (FACT) Scores
Tidsramme: Up to 6 months
|
The relationship between PK-guided docetaxel patient PK profiles and the Function Assessment of Cancer Therapy (FACT) Taxane and Breast Cancer scores will be described.
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Up to 6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Christine Walko, Pharm.D., H. Lee Moffitt Cancer Center and Research Institute
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
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 (Faktiske)
9. februar 2016
Primær færdiggørelse (Faktiske)
29. september 2017
Studieafslutning (Faktiske)
31. januar 2019
Datoer for studieregistrering
Først indsendt
15. juli 2015
Først indsendt, der opfyldte QC-kriterier
16. juli 2015
Først opslået (Skøn)
20. juli 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. september 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. september 2020
Sidst verificeret
1. september 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Hudsygdomme
- Neoplasmer
- Neoplasmer efter sted
- Brystsygdomme
- Brystneoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Antirheumatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Docetaxel
- Cyclofosfamid
Andre undersøgelses-id-numre
- MCC-18118
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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 .
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