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A Study of Avastin (Bevacizumab) in Combination With Low-Dose-Interferon in Patients With Metastatic Clear Cell Renal Cell Carcinoma (RCC).

22. Mai 2015 aktualisiert von: Hoffmann-La Roche

An Open Label Study of the Effect of First Line Treatment With Avastin (Bevacizumab) in Combination With Low-dose Interferon on Progression-free Survival in Patients With Metastatic Clear Cell Renal Cell Carcinoma.

This single arm study will assess progression free survival, tumor response and safety of Avastin in combination with interferon alfa-2a (IFN) as first line treatment in patients with metastatic clear cell renal cell carcinoma. Patients will receive Avastin (10mg/kg iv) every 2 weeks in combination with a low dose of interferon alfa-2a (3 MIU sc three times per week (t.i.w.). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

146

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

  • Deutschland
      • Arnsberg, Deutschland, 59755
      • Augsburg, Deutschland, 86156
      • Berlin, Deutschland, 10117
      • Berlin, Deutschland, 13055
      • Freiburg, Deutschland, 79106
      • Homburg/Saar, Deutschland, 66424
      • Leipzig, Deutschland, 04103
      • München, Deutschland, 81241
      • Münster, Deutschland, 48149
      • Offenburg, Deutschland, 77652
      • Planegg, Deutschland, 82152
      • Stuttgart, Deutschland, 70174
      • Weiden, Deutschland, 92637
  • Estland
      • Tallinn, Estland, 13419
      • Tallinn, Estland, 10617
      • Tartu, Estland, 50406
  • Finnland
      • Seinäjoki, Finnland, 60220
      • Turku, Finnland, 20520
  • Griechenland
      • Larissa, Griechenland, 41 110
      • Thessaloniki, Griechenland, 56429
      • Thessaloniki, Griechenland, 54639
  • Italien
      • Milano, Italien, 20100
      • Napoli, Italien, 80131
      • Pisa, Italien, 56100
  • Litauen
      • Kaunas, Litauen, 50009
      • Vilnius, Litauen, 08661
  • Niederlande
      • Amstelveen, Niederlande, 1186 AH
      • Eindhoven, Niederlande, 5623 EJ
      • Maastricht, Niederlande, 6229 HX
      • Nijmegen, Niederlande, 6525 GA
  • Russische Föderation
      • Barnaul, Russische Föderation, 656049
      • Ekaterinburg, Russische Föderation, 620102
      • Moscow, Russische Föderation, 125284
      • Moscow, Russische Föderation, 115478
      • Moscow, Russische Föderation, 117837
      • Obninsk, Russische Föderation, 249020
      • St Petersburg, Russische Föderation
      • UFA, Russische Föderation, 450054
      • Ulyanovsk, Russische Föderation, 432063
  • Schweden
      • Eskilstuna, Schweden, 63188
      • Linkoeping, Schweden, 58185
      • Sundsvall, Schweden, 85186
      • Vaxjo, Schweden, 35185
  • Schweiz
      • Aarau, Schweiz, 5000
      • Locarno, Schweiz, 6601
      • Zürich, Schweiz, 8063
  • Tschechische Republik
      • Olomouc, Tschechische Republik, 775 20
      • Praha 2, Tschechische Republik, 128 08
  • Vereinigtes Königreich
      • Cambridge, Vereinigtes Königreich, CB2 2QQ
      • Cardiff, Vereinigtes Königreich, CF14 2TL

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;
  • metastatic RCC with majority (>50%) of conventional clear-cell type;
  • prior total nephrectomy for primary RCC;
  • at least one measurable or non-measurable lesions;
  • ECOG performance score of 0 or 2.

Exclusion Criteria:

  • prior systemic treatment for metastatic RCC;
  • current or previously treated but non-stable CNS metastases or spinal cord compression;
  • major surgery (including open biopsy) or radiation therapy within 28 days prior to enrollment;
  • significant cardiovascular disease within 6 months prior to enrollment.

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
Experimental: 1
Arzneimittel: bevacizumab [Avastin]
10mg/kg iv infusion every 2 weeks
Arzneimittel: interferon alfa-2a
3 MIU sc t.i.w.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Progression-Free Survival (PFS) - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months
Zeitfenster: 12 and 24 months
PFS at 12 and 24 months is an estimate of the percentages of participants expected to be progression free at 12 and 24 months based on Kaplan-Meier survival analysis of the PFS data. PFS was defined as the time period from the first postbaseline tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.
12 and 24 months
PFS - Percentage of Participants With an Event
Zeitfenster: Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.
Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
PFS - Time to Event
Zeitfenster: Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.
Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With a Best Overall Response of Complete Reponse (CR) or Partial Response (PR)
Zeitfenster: Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
Percentage of participants with objective response, termed responders, based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study greater than or equal to (≥)4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]). No new lesions. PR was defined as ≥30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
Overall Survival (OS) - Percentage of Participants Estimated to be Alive at 12 and 24 Months
Zeitfenster: Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
OS at 12 and 24 months is the estimate of the percentages of participants expected to alive at 12 and 24 months based on Kaplan-Meier survival analysis of the survival data. Median OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.
Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
OS - Percentage of Participants With an Event
Zeitfenster: Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.
Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
OS - Time to Event
Zeitfenster: Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.
Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit
Zeitfenster: Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and End of Treatment (EOT)
EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). Answers from the questionnaire for each dimension (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) was classified into one of 2 categories: 'no problems' or 'any problems', and the percentage of participants in each category was determined.
Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and End of Treatment (EOT)
EQ-5D - Visual Analog Scale (VAS)
Zeitfenster: Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and EOT
EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 millimeters (mm) (best imaginable health state); higher scores indicate a better health state. Participants were asked to rate their health state and mark the line; the distance from the left edge was recorded. For change from baseline a negative value represents a worsening in the health state and a positive value represents an improvement in the health state.
Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and EOT

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hoffmann-La Roche

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

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. Dezember 2008

Primärer Abschluss (Tatsächlich)

1. Februar 2012

Studienabschluss (Tatsächlich)

1. Februar 2012

Studienanmeldedaten

Zuerst eingereicht

21. November 2008

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. November 2008

Zuerst gepostet (Schätzen)

24. November 2008

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

27. Mai 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. Mai 2015

Zuletzt verifiziert

1. Mai 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • MO21609
  • 2007-006611-23

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