Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) as Maintenance Treatment in Patients With Metastatic Colorectal Cancer

16. juli 2014 opdateret af: Hoffmann-La Roche

A Randomized, Multicenter Phase III Trial to Assess the Efficacy and Safety of Bevacizumab and Capecitabine as Maintenance Treatment, After Initial Combination Treatment With Capecitabine, Oxaliplatin and Bevacizumab in Patients With Metastatic Colorectal Adenocarcinoma

This 2 arm study assessed the efficacy and safety of maintenance treatment with Avastin (bevacizumab) + Xeloda (capecitabine), after initial treatment with Xeloda + oxaliplatin + Avastin, in patients with metastatic colorectal cancer. Patients were randomized into one of 2 groups to receive 1) Xeloda + oxaliplatin + Avastin until disease progression or 2) Xeloda + oxaliplatin + Avastin for 6 3-week cycles, followed by Xeloda + Avastin until disease progression. Xeloda was administered at a dose of 1000 mg/m^2 orally twice a day on days 1-14 of each cycle, oxaliplatin at a dose of 130 mg/m^2 intravenously (iv) on day 1 of each cycle, and Avastin at a dose of 7.5 mg/kg iv on day 1 of each cycle.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

123

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Kalkun
      • Ankara, Kalkun, 06100
      • Ankara, Kalkun, 06500
      • Ankara, Kalkun, 06590
      • Gaziantep, Kalkun, 27310
      • Istanbul, Kalkun, 34300
      • Istanbul, Kalkun, 34390
      • Istanbul, Kalkun, 34890
      • Izmir, Kalkun, 35100
      • Izmir, Kalkun, 35340
      • S?hhiye, ANKARA, Kalkun, 06100

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

Alle

Beskrivelse

Inclusion Criteria:

  • Adult patients, ≥ 18 years of age.
  • Histologically confirmed colon or rectal cancer, with unresectable metastatic disease.
  • At least 1 measurable lesion.
  • Outpatient, with Eastern Cooperative Oncology Group (ECOG) Performance Status = 0-1.

Exclusion Criteria:

  • Previous treatment with Avastin.
  • Previous systemic treatment for advanced or metastatic disease.
  • clinically significant cardiovascular disease.
  • Daily chronic treatment with high doses of aspirin (> 325 mg/day) or non-steroidal anti-inflammatory drugs.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Bevacizumab+capecitabine+oxaliplatin
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
Medicin: Bevacizumab
Bevacizumab was supplied as a solution in single-use vials.
Andre navne:
  • Avastin
Medicin: Capecitabin
Capecitabin blev leveret som filmovertrukne tabletter.
Andre navne:
  • Xeloda
Medicin: Oxaliplatin
Oxaliplatin was supplied as a lyophilized powder in vials.
Andre navne:
  • Eloxatin
Eksperimentel: Bevacizumab(B)+capecitabine(C)+oxaliplatin followed by B+C
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
Medicin: Bevacizumab
Bevacizumab was supplied as a solution in single-use vials.
Andre navne:
  • Avastin
Medicin: Capecitabin
Capecitabin blev leveret som filmovertrukne tabletter.
Andre navne:
  • Xeloda
Medicin: Oxaliplatin
Oxaliplatin was supplied as a lyophilized powder in vials.
Andre navne:
  • Eloxatin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-free Survival
Tidsramme: Baseline to the end of the study (up to 4 years, 2 months)
Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
Baseline to the end of the study (up to 4 years, 2 months)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival
Tidsramme: Baseline to the end of the study (up to 4 years, 2 months)
Overall survival was defined as the time from the first administration of study drug to death.
Baseline to the end of the study (up to 4 years, 2 months)
Percentage of Participants With a Complete Response or a Partial Response
Tidsramme: Baseline to the end of the study (up to 4 years, 2 months)
A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
Baseline to the end of the study (up to 4 years, 2 months)
Time Until a Complete Response or a Partial Response
Tidsramme: Baseline to Month 13
Time until a complete response or a partial response was defined as the time from the first administration of study drug until the first complete response or partial response.
Baseline to Month 13
Duration of Response
Tidsramme: Baseline to the end of the study (up to 4 years, 2 months)
Duration of response was defined as the time from the first complete response or partial response until disease progression or death. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
Baseline to the end of the study (up to 4 years, 2 months)
Percentage of Participants With Metastatic Lesions Previously Considered Inoperable Who Became Operable and Underwent Surgery
Tidsramme: Baseline to the end of the study (up to 4 years, 2 months)
Baseline to the end of the study (up to 4 years, 2 months)
Percentage of Participants With a R0 Resection
Tidsramme: Baseline to the end of the study (up to 4 years, 2 months)
An R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.
Baseline to the end of the study (up to 4 years, 2 months)

Samarbejdspartnere og efterforskere

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

Sponsor

Hoffmann-La Roche

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. maj 2012

Studieafslutning (Faktiske)

1. maj 2012

Datoer for studieregistrering

Først indsendt

18. februar 2008

Først indsendt, der opfyldte QC-kriterier

18. februar 2008

Først opslået (Skøn)

26. februar 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. august 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juli 2014

Sidst verificeret

1. juli 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ML21440

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 .

Abonner