A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) in Patients With Advanced or Metastatic Liver Cancer
7 maj 2014 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
45
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Melbourne, Australien, 3181
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Hong Kong, Hong Kong
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Singapore, Singapore, 169610
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Kueishan, Taiwan, 333
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Taipei, Taiwan, 114
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Taipei, Taiwan, 00112
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Taipei, Taiwan, 106
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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
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
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: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Avastin + Xeloda
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7.5mg/kg iv on day 1 of each 3 week cycle.
1600mg/m2/day po in 2 divided doses, on days 1 to 14 of each 3 week cycle.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Percentage of Participants With Objective Response (OR)
Tidsram: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
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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.
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Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Percentage of Participants With Disease Control
Tidsram: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
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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.
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Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
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Time to Disease Progression - Percentage of Participants With an Event
Tidsram: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
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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.
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Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
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Time to Disease Progression
Tidsram: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
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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.
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Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
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Time to Disease Progression - Percentage of Participants Progression-free at 12 Months
Tidsram: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
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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.
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Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
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Overall Survival - Percentage of Participants With an Event
Tidsram: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
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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.
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Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
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Overall Survival
Tidsram: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
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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.
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Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
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Overall Survival - Percentage of Participants Event Free at 12 Months
Tidsram: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
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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.
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Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
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 maj 2005
Primärt slutförande (Faktisk)
1 mars 2008
Avslutad studie (Faktisk)
1 mars 2008
Studieregistreringsdatum
Först inskickad
3 december 2013
Först inskickad som uppfyllde QC-kriterierna
11 december 2013
Första postat (Uppskatta)
17 december 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
6 juni 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 maj 2014
Senast verifierad
1 maj 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer
- Neoplasmer efter plats
- Neoplasmer i matsmältningssystemet
- Leversjukdomar
- Neoplasmer i levern
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Antineoplastiska medel, immunologiska
- Angiogeneshämmare
- Angiogenesmodulerande medel
- Tillväxtämnen
- Tillväxthämmare
- Capecitabin
- Bevacizumab
Andra studie-ID-nummer
- ML18469
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 .