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Phase I Imaging Study Evaluating Gem/Cis or Gem/Carbo for Participants With Non-Small Cell Lung Cancer (MK-0000-083 AM3)

15. desember 2017 oppdatert av: Merck Sharp & Dohme LLC

A Multicenter Phase Ib Trial to Measure [18F]-Fluorodeoxyglucose Uptake by Positron Emission Tomography in Stage IIIB and IV Non-Small Cell Lung Cancer Before and After Chemotherapy With Gemcitabine and Cisplatin or Carboplatin

This study will use imaging to look at tumor response to combination chemotherapy of gemcitabine (Gem) and cisplatin (Cis) or gemcitabine and carboplatin (Carbo) in non small cell lung cancer (NSCLC).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

68

Fase

  • Fase 1

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Has histologically or cytopathologically confirmed metastatic or locally advanced stage IIIB/IV Non-small cell lung cancer (NSCLC)
  • Has measurable disease
  • Has not been previously treated with surgery (involving the thorax), radiation (unless it was for a metastatic site), or chemotherapy for NSCLC
  • Is 18 years of age or older
  • Has a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale
  • Women of childbearing potential have a negative pregnancy test

Exclusion Criteria:

  • Is participating in or has participated in a study with an investigational compound or device within 30 days or 5 half-lives of the start of treatment
  • Has untreated brain metastases related to their NSCLC or carcinomatous meningitis
  • Abuses drugs or alcohol
  • Is pregnant or breastfeeding
  • Is Human Immunodeficiency Virus (HIV) positive
  • Has active viral hepatitis
  • Has hearing loss
  • Has poorly controlled diabetes mellitus
  • Is allergic to gemcitabine, cisplatin or carboplatin

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Gem/Cis or Gem/Carbo
Stråling: Comparator: CT or MRI and FDG-PET
Participants have 4 computed tomography (CT) or magnetic resonance imaging (MRI) scans at screening, baseline, at the end of each treatment cycle (day 21 and day 42.) They also have FDG-PET scans, 2 at Baseline and one at the end of each treatment cycle.
Legemiddel: Gemcitabine and Cisplatin or Gemcitabine and Carboplatin
Gemcitabine administered intravenously at a dose of 1000-1250 mg/m^2 on Day 1 and Day 8 of each cycle; Cisplatin administered intravenously at a dose of 60-85 mg/m^2 or Carboplatin at a dose of 4-6 Area Under the Curve (AUC) on Day 1 of each cycle. Two cycles are given 3 weeks apart.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy at a Threshold of a 20% Decrease in SUVmean
Tidsramme: Weeks 3 and 6 following chemotherapy
Metabolic response conversion rate is the number of participants initially classified as non-metabolic responders relative to baseline at week 3 after starting chemotherapy, who are then, relative to week 3, reclassified as metabolic responders at week 6 after starting chemotherapy, based on a pre-specified threshold of a 20% decrease in mean standardized uptake value (SUVmean) of [18F]-Fluorodeoxyglucose (FDG). The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.
Weeks 3 and 6 following chemotherapy

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Repeatability of FDG SUVmean at Baseline
Tidsramme: Between -14 to -6 days and between -5 to 0 days prior to starting chemotherapy
Two positron emission tomography (PET) scans are obtained on different days at baseline, as close together as possible, under conditions of no biological change, to measure FDG SUVmean. The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.
Between -14 to -6 days and between -5 to 0 days prior to starting chemotherapy
Change in FDG-PET Uptake From Baseline to Week 3
Tidsramme: Baseline and Week 3
Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval. The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.
Baseline and Week 3
Change in FDG-PET Uptake From Week 3 to Week 6
Tidsramme: Week 3 and Week 6
Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval. The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.
Week 3 and Week 6
Change in FGD-PET Uptake From Baseline to Week 6
Tidsramme: Baseline and Week 6

Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval.

The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.
Baseline and Week 6

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Merck Sharp & Dohme LLC

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2009

Primær fullføring (Faktiske)

10. juni 2010

Studiet fullført (Faktiske)

13. april 2011

Datoer for studieregistrering

Først innsendt

7. januar 2008

Først innsendt som oppfylte QC-kriteriene

11. januar 2008

Først lagt ut (Anslag)

24. januar 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. januar 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. desember 2017

Sist bekreftet

1. desember 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 0000-083
  • 2007_662 (Annen identifikator: Merck)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Comparator: CT or MRI and FDG-PET

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

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Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

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