A Study of Tarceva (Erlotinib) and Avastin (Bevacizumab) in Patients With Advanced or Metastatic Liver Cancer.
12. Juni 2014 aktualisiert von: Hoffmann-La Roche
A Single Arm, Open Label Study of First Line Treatment With Tarceva Plus Avastin on Progression-free Survival in Patients With Advanced or Metastatic Liver Cancer
This single arm study evaluated the efficacy and safety of a combination of Tarceva and Avastin in patients with advanced or metastatic liver cancer.
Patients were treated with Tarceva 150 mg po daily plus Avastin 5 mg/kg intravenous (iv) every 2 weeks.
The anticipated time on study treatment was until disease progression, and the target sample size was <100 individuals.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
51
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Seoul, Korea, Republik von, 138-736
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Manila, Philippinen, 1000
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Kueishan, Taiwan, 333
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Tainan, Taiwan, 704
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Taipei, Taiwan, 00112
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Taipei, Taiwan, 106
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- adult patients, ≥ 18 years of age;
- advanced or metastatic liver cancer;
- ≥ 1 measurable lesion, not previously treated with local therapy within 4 weeks of enrollment.
Exclusion Criteria:
- prior or concomitant systemic anti-cancer treatment for advanced disease;
- patients at high risk of variceal bleeding;
- clinically significant cardiovascular disease;
- major surgery, open biopsy, or significant traumatic injury within 4 weeks of study start.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: bevacizumab + erlotinib
Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
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5 mg/kg iv on day 1 of each 2 week cycle.
150 mg orally (po) daily.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Percentage of Participants With Progression-free Survival (PFS)
Zeitfenster: Week 16
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Percentage of participants who were alive and without documented progressive disease 16 weeks after their first dose of study drug.
Diagnosis of Progressive Disease was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions.
PD required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
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Week 16
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Overall Response Rate (ORR)
Zeitfenster: Event driven (median follow-up 12 months)
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ORR was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR).
Analysis of tumor response was based on the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST), which was defined as the best response recorded from the start of trial treatment until disease progression/recurrence (or death), taking as reference for progressive disease (PD) the smallest measurements recorded since the treatment started.
CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels.
PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD.
PD required at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
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Event driven (median follow-up 12 months)
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Disease Control Rate (DCR)
Zeitfenster: Event driven (median follow-up 12 months)
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Disease Control Rate was defined as the percentage of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at least 8 weeks by Response Evaluation Criteria in Solid Tumours (RECIST).
CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels.
PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD.
SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; for non-target lesions persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits.
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Event driven (median follow-up 12 months)
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Time to Tumor Progression
Zeitfenster: Event driven (median follow-up 12 months)
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Time to tumor progression was defined as the time period in months from the start of study drug treatment to disease progression.
Progressive disease required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
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Event driven (median follow-up 12 months)
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Progression-free Survival (PFS)
Zeitfenster: Event driven (median follow-up 12 months)
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PFS was defined as the time period in months from the start of study drug treatment to the first of either progression or death.
Progressive disease required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
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Event driven (median follow-up 12 months)
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Overall Survival (OS)
Zeitfenster: Event driven (median follow-up 12 months)
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OS was defined as the time period in months from the start of study drug treatment to death.
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Event driven (median follow-up 12 months)
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Zeitfenster: Up to 107 Weeks
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An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.
A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
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Up to 107 Weeks
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. März 2008
Primärer Abschluss (Tatsächlich)
1. September 2010
Studienabschluss (Tatsächlich)
1. September 2010
Studienanmeldedaten
Zuerst eingereicht
18. Januar 2008
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
18. Januar 2008
Zuerst gepostet (Schätzen)
31. Januar 2008
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
14. Juli 2014
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
12. Juni 2014
Zuletzt verifiziert
1. Juni 2014
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Neubildungen
- Neubildungen nach Standort
- Neoplasmen des Verdauungssystems
- Leberkrankheiten
- Lebertumoren
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antineoplastische Mittel
- Antineoplastische Mittel, immunologische
- Angiogenese-Inhibitoren
- Angiogenese-modulierende Mittel
- Wuchsstoffe
- Wachstumshemmer
- Proteinkinase-Inhibitoren
- Erlotinib-Hydrochlorid
- Bevacizumab
Andere Studien-ID-Nummern
- ML21213
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