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

16 juli 2014 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

123

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Geneesmiddel: Bevacizumab
Bevacizumab was supplied as a solution in single-use vials.
Andere namen:
  • Avastin
Geneesmiddel: Capecitabine
Capecitabine werd geleverd als filmomhulde tabletten.
Andere namen:
  • Xeloda
Geneesmiddel: Oxaliplatin
Oxaliplatin was supplied as a lyophilized powder in vials.
Andere namen:
  • Eloxatin
Experimenteel: 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.
Geneesmiddel: Bevacizumab
Bevacizumab was supplied as a solution in single-use vials.
Andere namen:
  • Avastin
Geneesmiddel: Capecitabine
Capecitabine werd geleverd als filmomhulde tabletten.
Andere namen:
  • Xeloda
Geneesmiddel: Oxaliplatin
Oxaliplatin was supplied as a lyophilized powder in vials.
Andere namen:
  • Eloxatin

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression-free Survival
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Survival
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hoffmann-La Roche

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 2008

Primaire voltooiing (Werkelijk)

1 mei 2012

Studie voltooiing (Werkelijk)

1 mei 2012

Studieregistratiedata

Eerst ingediend

18 februari 2008

Eerst ingediend dat voldeed aan de QC-criteria

18 februari 2008

Eerst geplaatst (Schatting)

26 februari 2008

Updates van studierecords

Laatste update geplaatst (Schatting)

8 augustus 2014

Laatste update ingediend die voldeed aan QC-criteria

16 juli 2014

Laatst geverifieerd

1 juli 2014

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ML21440

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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