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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 de maio de 2015 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

146

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Arnsberg, Alemanha, 59755
      • Augsburg, Alemanha, 86156
      • Berlin, Alemanha, 10117
      • Berlin, Alemanha, 13055
      • Freiburg, Alemanha, 79106
      • Homburg/Saar, Alemanha, 66424
      • Leipzig, Alemanha, 04103
      • München, Alemanha, 81241
      • Münster, Alemanha, 48149
      • Offenburg, Alemanha, 77652
      • Planegg, Alemanha, 82152
      • Stuttgart, Alemanha, 70174
      • Weiden, Alemanha, 92637
  • Estônia
      • Tallinn, Estônia, 13419
      • Tallinn, Estônia, 10617
      • Tartu, Estônia, 50406
  • Federação Russa
      • Barnaul, Federação Russa, 656049
      • Ekaterinburg, Federação Russa, 620102
      • Moscow, Federação Russa, 125284
      • Moscow, Federação Russa, 115478
      • Moscow, Federação Russa, 117837
      • Obninsk, Federação Russa, 249020
      • St Petersburg, Federação Russa
      • UFA, Federação Russa, 450054
      • Ulyanovsk, Federação Russa, 432063
  • Finlândia
      • Seinäjoki, Finlândia, 60220
      • Turku, Finlândia, 20520
  • Grécia
      • Larissa, Grécia, 41 110
      • Thessaloniki, Grécia, 56429
      • Thessaloniki, Grécia, 54639
  • Holanda
      • Amstelveen, Holanda, 1186 AH
      • Eindhoven, Holanda, 5623 EJ
      • Maastricht, Holanda, 6229 HX
      • Nijmegen, Holanda, 6525 GA
  • Itália
      • Milano, Itália, 20100
      • Napoli, Itália, 80131
      • Pisa, Itália, 56100
  • Lituânia
      • Kaunas, Lituânia, 50009
      • Vilnius, Lituânia, 08661
  • Reino Unido
      • Cambridge, Reino Unido, CB2 2QQ
      • Cardiff, Reino Unido, CF14 2TL
  • República Checa
      • Olomouc, República Checa, 775 20
      • Praha 2, República Checa, 128 08
  • Suécia
      • Eskilstuna, Suécia, 63188
      • Linkoeping, Suécia, 58185
      • Sundsvall, Suécia, 85186
      • Vaxjo, Suécia, 35185
  • Suíça
      • Aarau, Suíça, 5000
      • Locarno, Suíça, 6601
      • Zürich, Suíça, 8063

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 1
Medicamento: bevacizumab [Avastin]
10mg/kg iv infusion every 2 weeks
Medicamento: interferon alfa-2a
3 MIU sc t.i.w.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Progression-Free Survival (PFS) - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months
Prazo: 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
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants With a Best Overall Response of Complete Reponse (CR) or Partial Response (PR)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Hoffmann-La Roche

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de dezembro de 2008

Conclusão Primária (Real)

1 de fevereiro de 2012

Conclusão do estudo (Real)

1 de fevereiro de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

21 de novembro de 2008

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de novembro de 2008

Primeira postagem (Estimativa)

24 de novembro de 2008

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

27 de maio de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

22 de maio de 2015

Última verificação

1 de maio de 2015

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • MO21609
  • 2007-006611-23

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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