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

16. juli 2014 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

123

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

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:

  • 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

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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.
Legemiddel: Bevacizumab
Bevacizumab was supplied as a solution in single-use vials.
Andre navn:
  • Avastin
Legemiddel: Capecitabin
Capecitabin ble levert som filmdrasjerte tabletter.
Andre navn:
  • Xeloda
Legemiddel: Oxaliplatin
Oxaliplatin was supplied as a lyophilized powder in vials.
Andre navn:
  • Eloxatin
Eksperimentell: 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.
Legemiddel: Bevacizumab
Bevacizumab was supplied as a solution in single-use vials.
Andre navn:
  • Avastin
Legemiddel: Capecitabin
Capecitabin ble levert som filmdrasjerte tabletter.
Andre navn:
  • Xeloda
Legemiddel: Oxaliplatin
Oxaliplatin was supplied as a lyophilized powder in vials.
Andre navn:
  • Eloxatin

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

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

Sponsor

Hoffmann-La Roche

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

1. mars 2008

Primær fullføring (Faktiske)

1. mai 2012

Studiet fullført (Faktiske)

1. mai 2012

Datoer for studieregistrering

Først innsendt

18. februar 2008

Først innsendt som oppfylte QC-kriteriene

18. februar 2008

Først lagt ut (Anslag)

26. februar 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

8. august 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. juli 2014

Sist bekreftet

1. juli 2014

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ML21440

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Legemiddelintervensjoner

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Forhold

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Legemiddelintervensjoner

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Sponsor / samarbeidspartnere

Steder

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