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A Study of Bevacizumab (Avastin) in Combination With Capecitabine (Xeloda) in Elderly Patients With Metastatic Colorectal Cancer

7 januari 2015 bijgewerkt door: Hoffmann-La Roche

A Randomised, Open-label Phase III Study to Assess Efficacy and Safety of Bevacizumab in Combination With Capecitabine as First-line Treatment for Elderly Patients With Metastatic Colorectal Cancer

This 2-arm study assessed the efficacy and safety of bevacizumab (Avastin) in combination with capecitabine (Xeloda), compared with capecitabine alone, in elderly patients with metastatic colorectal cancer. Patients were randomized to receive either bevacizumab (7.5 mg/kg intravenously on Day 1 of each 3-week cycle) in combination with capecitabine (1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle) or capecitabine (1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle) alone.

No notable trends or interactions in laboratory values, electrocardiogram, or vital signs suggesting an effect in either direction for capecitabine/bevacizumab combination therapy or capecitabine monotherapy were observed during the study.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

280

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
    • Ontario
      • London, Ontario, Canada, N6A 4L6
      • Ottawa, Ontario, Canada, K1H 8L6
      • Toronto, Ontario, Canada, M4N 3M5
      • Toronto, Ontario, Canada, M5B 1W8
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
  • Griekenland
      • Larissa, Griekenland, 41 110
      • Piraeus, Griekenland, 18537
  • Hongarije
      • Budapest, Hongarije, 1122
      • Budapest, Hongarije, 1083
      • Gyor, Hongarije, 9023
      • Zalaegerszeg-Pozva, Hongarije, 8900
  • Italië
    • Emilia-Romagna
      • Reggio Emilia, Emilia-Romagna, Italië, 42100
    • Lazio
      • Roma, Lazio, Italië, 00144
    • Puglia
      • Lecce, Puglia, Italië, 73100
    • Toscana
      • Firenze, Toscana, Italië, 50139
  • Korea, republiek van
      • Gyeonggi-do, Korea, republiek van, 410-769
      • Incheon, Korea, republiek van, 405-760
      • Seoul, Korea, republiek van, 110-744
      • Seoul, Korea, republiek van, 135-710
  • Mexico
      • Leon, Mexico, 37000
      • Mexico City, Mexico, 14000
      • Mexico City, Mexico, 14140
      • Mexico City, Mexico, 16200
      • Puebla, Mexico, 72530
  • Nederland
      • Apeldoorn, Nederland, 7334 DZ
      • Eindhoven, Nederland, 5623 EJ
      • Utrecht, Nederland, 3527 CE
  • Oostenrijk
      • Innsbruck, Oostenrijk, 6020
      • Linz, Oostenrijk, 4010
      • Salzburg, Oostenrijk, 5020
      • Wien, Oostenrijk, 1160
      • Wien, Oostenrijk, 1220
  • Polen
      • Krakow, Polen, 30-501
      • Krakow, Polen, 31-826
      • Warszawa, Polen, 02-097
  • Slovenië
      • Ljubljana, Slovenië, 1000
  • Spanje
      • Barcelona, Spanje, 08041
      • Jaen, Spanje, 23007
      • Madrid, Spanje, 28040
      • Murcia, Spanje, 30120
      • Zaragoza, Spanje, 50009
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spanje, 35016
    • Madrid
      • Leganes, Madrid, Spanje, 28911
  • Verenigd Koninkrijk
      • Bristol, Verenigd Koninkrijk, BS2 8ED
      • Colchester, Verenigd Koninkrijk, CO3 3NB
      • Glasgow, Verenigd Koninkrijk, G12 0YN
      • Leicester, Verenigd Koninkrijk, LE1 5WW
      • London, Verenigd Koninkrijk, W2 1NY
      • Manchester, Verenigd Koninkrijk, M20 4BX
      • Nottingham, Verenigd Koninkrijk, NG5 1PB
      • Rhyl, Verenigd Koninkrijk, LL18 5UJ
      • Sutton, Verenigd Koninkrijk, SM2 5PT

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

70 jaar en ouder (Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Adult patients, ≥ 70 years of age.
  • Cancer of the colon or rectum.
  • Metastatic disease diagnosed ≤ 6 months before enrollment.
  • ≥ 1 measurable metastatic lesion.

Exclusion Criteria:

  • Adjuvant anti-vascular endothelial growth factor (VEGF) treatment.
  • Prior chemotherapeutic treatment for metastatic colorectal cancer.
  • Past or current history of other malignancies (with the exception of basal and squamous cell cancer of the skin, or in situ cancer of the cervix).
  • Clinically significant cardiovascular disease.
  • Current or recent daily use of aspirin (> 325 mg/day) or other non-steroidal anti-inflammatory drug (NSAID), or full dose anticoagulants.

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
Experimenteel: Bevacizumab + capecitabine
Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Geneesmiddel: Bevacizumab
Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Bevacizumab was supplied in single-use vials.
Andere namen:
  • Avastin
Geneesmiddel: Capecitabine
Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Capecitabine was supplied as tablets.
Andere namen:
  • Xeloda
Actieve vergelijker: Capecitabine
Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Geneesmiddel: Capecitabine
Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Capecitabine was supplied as tablets.
Andere namen:
  • Xeloda

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression-free Survival
Tijdsspanne: Baseline to the end of the study (up to 5 years 8 months)
Progression-free survival was defined as the time in months from the date of randomization to the date of disease progression or death from any cause, whichever occurred first. All measurable lesions (maximum of 5 per organ and 10 in total, those with the longest diameter and suitability for accurate repeated measurements) were identified as target lesions (TL). A sum of the longest diameter for all TLs was calculated and reported as the baseline sum longest diameter (SLD). All other lesions were identified as non-TLs and recorded at baseline. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.
Baseline to the end of the study (up to 5 years 8 months)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Best Overall Response (BOR)
Tijdsspanne: Baseline to the end of the study (up to 5 years 8 months)
BOR was defined as the best response (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], not evaluable [NE], or not assessed [NA]) recorded from the start of study treatment until disease progression (PD) or death. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.
Baseline to the end of the study (up to 5 years 8 months)
Duration of Response
Tijdsspanne: Baseline to the end of the study (up to 5 years 8 months)
Duration of response was defined as the time in months from the first confirmed complete response (CR) or partial response (PR) until disease progression or death from any cause, whichever occurred first. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs.
Baseline to the end of the study (up to 5 years 8 months)
Time to Response
Tijdsspanne: Baseline to the end of the study (up to 5 years 8 months)
Time to response was defined as the time in months from the date of first study treatment to the date of the first documentation of complete response (CR) or partial response (PR), whichever occurred first. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. Participants who did not have a confirmed response were censored at the date of the last evaluable tumor assessment, or if that was unavailable, at the date of the first dose of study medication.
Baseline to the end of the study (up to 5 years 8 months)
Overall Survival
Tijdsspanne: Baseline to the end of the study (up to 5 years 8 months)
Overall survival was defined as the time in months from randomization to death from any cause.
Baseline to the end of the study (up to 5 years 8 months)
Eastern Cooperative Oncology Group (ECOG) Performance Status
Tijdsspanne: Baseline to the Safety Follow-up which occurred 28 days after the last dose of treatment (up to 5 years 8 months).
The ECOG performance status is a scale used to quantify cancer patients' general well-being and activities of daily life. The scale ranges from 0 to 5, with 0 denoting perfect health and 5 indicating death. The 6 categories are 0=Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1=Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2=Symptomatic, < 50% in bed during the day (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours), 3=Symptomatic, > 50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours), 4=Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair), 5=Death. Reported is the percentage of participants in each of the 6 ECOG performance status categories.
Baseline to the Safety Follow-up which occurred 28 days after the last dose of treatment (up to 5 years 8 months).
Percentage of Participants Requiring Additional Treatment for Malignancy
Tijdsspanne: Baseline to the end of the study (up to 5 years 8 months)
Reported is the percentage of participants requiring additional treatment for malignancy in the survival follow-up period.
Baseline to the end of the study (up to 5 years 8 months)
Duration of Follow-up
Tijdsspanne: Baseline to the end of the study (up to 5 years 8 months)
Duration of follow-up is defined as the time in days from randomization until disease progression or death, or time to censoring for overall survival.
Baseline to the end of the study (up to 5 years 8 months)
AEs, Laboratory Parameters, Vital Signs
Tijdsspanne: Throughout study
Throughout study

Medewerkers en onderzoekers

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

Sponsor

Hoffmann-La Roche

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

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 juli 2007

Primaire voltooiing (Werkelijk)

1 maart 2013

Studie voltooiing (Werkelijk)

1 maart 2013

Studieregistratiedata

Eerst ingediend

11 juni 2007

Eerst ingediend dat voldeed aan de QC-criteria

11 juni 2007

Eerst geplaatst (Schatting)

12 juni 2007

Updates van studierecords

Laatste update geplaatst (Schatting)

8 januari 2015

Laatste update ingediend die voldeed aan QC-criteria

7 januari 2015

Laatst geverifieerd

1 januari 2015

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • MO19286

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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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