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

7 januari 2015 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

280

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

70 år och äldre (Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: 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.
Andra namn:
  • Avastin
Läkemedel: 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.
Andra namn:
  • Xeloda
Aktiv komparator: Capecitabine
Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Läkemedel: 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.
Andra namn:
  • Xeloda

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Progression-free Survival
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Best Overall Response (BOR)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Throughout study
Throughout study

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hoffmann-La Roche

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2007

Primärt slutförande (Faktisk)

1 mars 2013

Avslutad studie (Faktisk)

1 mars 2013

Studieregistreringsdatum

Först inskickad

11 juni 2007

Först inskickad som uppfyllde QC-kriterierna

11 juni 2007

Första postat (Uppskatta)

12 juni 2007

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

8 januari 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 januari 2015

Senast verifierad

1 januari 2015

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • MO19286

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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