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Ondansetron Versus Palonosetron Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC)

13. oktober 2013 opdateret af: Rachel Layman, Ohio State University Comprehensive Cancer Center

Pilot Study on the Efficacy of an Ondansetron Versus Palonosetron-containing Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC).

Palonosetron is different from ondansetron because it stays in the body longer and may prevent nausea and vomiting for a longer period of time than ondansetron. It is standard practice to use dexamethasone and aprepitant with either ondansetron or palonosetron to prevent nausea and vomiting caused by highly emetogenic chemotherapy. Although these combinations are commonly used, they have never been compared to each other. The purpose of this study is to record the amount of nausea and vomiting, and the amount of "rescue" medication that is used with these two different anti-emetic regimens

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PRIMARY OBJECTIVES:

I. The goal of this study is to evaluate the overall complete response rate (CR, no emesis and no use of rescue medication from 0 to 120 hours after chemotherapy) of two different antiemetic regimens (palonosetron + aprepitant + dexamethasone and ondansetron + aprepitant + dexamethasone) for patients undergoing the first cycle of highly emetogenic chemotherapy (HEC).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive palonosetron hydrochloride intravenously (IV) 30 minutes prior to chemotherapy on day 1, aprepitant orally (PO) 60 minutes prior to chemotherapy on days 1-3, and dexamethasone PO 30 minutes prior to chemotherapy on days 1-4.

ARM II: Patients receive ondansetron PO 30 minutes prior to chemotherapy on day 1 and aprepitant and dexamethasone as in Arm I.

After completion of study treatment, patients are followed up for 7 days.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • Ohio State University Medical 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 88 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Confirmed malignancy
  • Chemotherapy naive or treated with only low or minimally emetogenic chemotherapy in the past (as defined by the National Comprehensive Cancer Network version [v].2.201 Antiemetic Guidelines)
  • Scheduled to receive the first dose of their first cycle of HEC
  • Patients receiving multi-day chemotherapy, the HEC portion must be on day 1 and the remaining days of chemotherapy must be minimally emetogenic (i.e. fluorouracil)
  • Performance status of Eastern Cooperative Oncology Group (ECOG) grade 0-2
  • Able to provide informed consent
  • Able to read and write in English or have someone that can that can translate to them and record their diary entries
  • Able to take oral medications

  • Patients are allowed to participate in a concurrent clinical trial, if the other trial:

    • Does not mandate an antiemetic regimen that interferes with this study
    • Allows antiemetic administration at the physician's discretion
    • Does not prohibit the patient from participating in this study
  • Patients must be willing to participate with daily diary entries for 5 days following chemotherapy, and agree to have a 5 minute follow-up call on day 2 or 3 and day 5, 6 or 7

Exclusion Criteria:

  • Has stage IV (metastatic) disease
  • Known hypersensitivity to ondansetron, palonosetron, aprepitant, or dexamethasone
  • Have received or will receive agents that are strong cytochrome P450 3A4 (CYP450 3A4) inducers and/or inhibitors and known to cause clinically relevant drug interactions within one week prior to study treatment and continuing through day 5; any vomiting or retching within 24 hours before administration of chemotherapy
  • Grade 2 nausea or greater, according to the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.0) within 24 hours before administration of chemotherapy
  • Received an antiemetic within 24 hours before study drug administration, excluding the use of benzodiazepines
  • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2.5 times upper limit of normal
  • Total bilirubin > 1.5 times upper limit of normal

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm I (palonosetron hydrochloride)
Patients receive palonosetron hydrochloride IV 30 minutes prior to chemotherapy on day 1, aprepitant PO (by mouth) 60 minutes prior to chemotherapy on days 1-3, and dexamethasone PO 30 minutes prior to chemotherapy on days 1-4.
Medicin: dexamethason
Givet PO
Andre navne:
  • Aeroseb-Dex
  • Decaderm
  • Dekadron
  • DM
  • DXM
Medicin: aprepitant
Given by mouth
Andre navne:
  • Emend
  • L-754030
  • MK-0869
  • ONO-7436
Medicin: palonosetron hydrochloride
Given IV(intervenous infusion)
Andre navne:
  • Aloxi
  • RS 25259-197
Eksperimentel: Arm II (ondansetron)
Patients receive ondansetron PO 30 minutes prior to chemotherapy on day 1 and aprepitant and dexamethasone as in Arm I.
Medicin: dexamethason
Givet PO
Andre navne:
  • Aeroseb-Dex
  • Decaderm
  • Dekadron
  • DM
  • DXM
Medicin: aprepitant
Given by mouth
Andre navne:
  • Emend
  • L-754030
  • MK-0869
  • ONO-7436
Medicin: ondansetron
Given PO
Andre navne:
  • Zofran
  • GR 38032F
  • GR-C507/75

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall CR(Complete Response)After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication
Tidsramme: Up to 120 hours after completion of chemotherapy
We will use exact binomial methods to estimate proportions and their associated 95% confidence intervals.
Up to 120 hours after completion of chemotherapy

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acute CR (Complete Response)
Tidsramme: 0-24 hours after chemotherapy
After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication from time 0 to 24 hours.
0-24 hours after chemotherapy
Delayed CR (Complete Response)
Tidsramme: 24-120 hours after chemotherapy
After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication From Time 24to 120 Hours.
24-120 hours after chemotherapy
Percentage of Patients Who Experienced Grade 1, 2 or 3 Nausea From Time 0 to 120 Hours
Tidsramme: Time 0 to 120 hours
The percentage of patients who experienced grade 1, 2 or 3 nausea from time 0 to 120 hours. Nausea graded using the National Cancer Institute (NCI) CTCAE (Common Toxicity Criteria for Adverse Effects)version 4.0 Nausea Grading Scale. Grade 1=Loss of appetite without alteration in eating habits, Grade 2= Oral intake decreased without significant weight loss, dehydration or malnutrition, Grade 3= Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated.
Time 0 to 120 hours
Visual Analog Scale (VAS) Scores
Tidsramme: Up to 7 days after completion of study treatment
Up to 7 days after completion of study treatment
Use of Rescue Medication for Each Treatment Arm
Tidsramme: From time 0 to 120 hours
From time 0 to 120 hours
Percentage of Patients Who Experienced Grade 1, 2 or 3 Vomiting From Time 0 to 120 Hours
Tidsramme: From time 0 to 120 hours
The percentage of patients who experienced grade 1, 2 or 3 vomiting from time 0 to 120 hours. Nausea graded using the National Cancer Institute (NCI) CTCAE v 4.0 vomiting Grading Scale. Grade 1=Loss of appetite without alteration in eating habits, Grade 2= Oral intake decreased without significant weight loss, dehydration or malnutrition, Grade 3= Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated.
From time 0 to 120 hours

Samarbejdspartnere og efterforskere

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

Sponsor

Ohio State University Comprehensive Cancer Center

Efterforskere

  • Ledende efterforsker: Rachel Layman, Ohio State University

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

1. januar 2011

Primær færdiggørelse (Faktiske)

1. august 2011

Studieafslutning (Faktiske)

1. august 2011

Datoer for studieregistrering

Først indsendt

10. juli 2012

Først indsendt, der opfyldte QC-kriterier

12. juli 2012

Først opslået (Skøn)

13. juli 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. november 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. oktober 2013

Sidst verificeret

1. oktober 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • OSU-10118
  • NCI-2012-01009 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

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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