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A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) in Patients With Advanced or Metastatic Liver Cancer

7 mei 2014 bijgewerkt door: Hoffmann-La Roche

A Single-arm, Open-label Study of Avastin Plus Xeloda on Objective Treatment Response in Patients With Advanced or Metastatic Liver Cancer Who Have Had no Previous Cytotoxic Chemotherapy

This study will evaluate the efficacy and safety of oral Xeloda (capecitabine) plus intravenous Avastin (bevacizumab) in patients with advanced or metastatic liver cancer. The anticipated time on study treatment is 3-12 months.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

45

Fase

  • Fase 2

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

  • Australië
      • Melbourne, Australië, 3181
  • Hongkong
      • Hong Kong, Hongkong
  • Singapore
      • Singapore, Singapore, 169610
  • Taiwan
      • Kueishan, Taiwan, 333
      • Taipei, Taiwan, 114
      • Taipei, Taiwan, 00112
      • Taipei, Taiwan, 106

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;
  • advanced or metastatic liver cancer;
  • >=1 measurable lesion.

Exclusion Criteria:

  • current radiotherapy, chemotherapy, or other experimental therapies;
  • prior cytotoxic chemotherapy;
  • major surgery, open biopsy, or traumatic injury within 28 days of study entry;
  • history of a malignancy during the last 5 years, other than cutaneous basal cell cancer or in situ cervical cancer.

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: Niet-gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Avastin + Xeloda
Geneesmiddel: bevacizumab [Avastin]
7.5mg/kg iv on day 1 of each 3 week cycle.
Geneesmiddel: capecitabine [Xeloda]
1600mg/m2/day po in 2 divided doses, on days 1 to 14 of each 3 week cycle.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With Objective Response (OR)
Tijdsspanne: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions.
Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With Disease Control
Tijdsspanne: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
The percentage of participants with disease control was based on assessment of confirmed CR, PR, or stable disease (SD) according to RECIST criteria. Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as ≥ 30 % decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions. SD was defined as not qualifying for PR or progressive disease.
Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Time to Disease Progression - Percentage of Participants With an Event
Tijdsspanne: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment.
Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Time to Disease Progression
Tijdsspanne: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of their tumor assessment.
Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Time to Disease Progression - Percentage of Participants Progression-free at 12 Months
Tijdsspanne: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment.
Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
Overall Survival - Percentage of Participants With an Event
Tijdsspanne: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive.
Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
Overall Survival
Tijdsspanne: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive. Median Overall Survival was estimated using the Kaplan-Meier method.
Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
Overall Survival - Percentage of Participants Event Free at 12 Months
Tijdsspanne: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive.
Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.

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 mei 2005

Primaire voltooiing (Werkelijk)

1 maart 2008

Studie voltooiing (Werkelijk)

1 maart 2008

Studieregistratiedata

Eerst ingediend

3 december 2013

Eerst ingediend dat voldeed aan de QC-criteria

11 december 2013

Eerst geplaatst (Schatting)

17 december 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

6 juni 2014

Laatste update ingediend die voldeed aan QC-criteria

7 mei 2014

Laatst geverifieerd

1 mei 2014

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ML18469

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