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Bevacizumab, Oxaliplatin, and Docetaxel in Treating Patients With Locally Advanced Unresectable or Metastatic Stomach or Gastroesophageal Junction Cancer

13 de março de 2019 atualizado por: Philip Philip, Barbara Ann Karmanos Cancer Institute

Phase II Trial of Bevacizumab, Docetaxel, and Oxaliplatin in Gastric and Gastroesophageal Junction Cancer

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as oxaliplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with oxaliplatin and docetaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with oxaliplatin and docetaxel works in treating patients with locally advanced unresectable or metastatic stomach or gastroesophageal junction cancer.

Visão geral do estudo

Descrição detalhada

OBJECTIVES:

Primary

  • Determine the time to progression in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma treated with bevacizumab, oxaliplatin, and docetaxel.

Secondary

  • Determine the response rate in patients treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.
  • Determine time to treatment failure and overall survival of patients treated with this regimen.
  • Determine the changes in general and disease-specific quality of life, in terms of response to treatment, in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 120 minutes, and docetaxel IV over 60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR.

After completion of study treatment, patients are followed periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 18-23 months.

Tipo de estudo

Intervencional

Inscrição (Real)

39

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

    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48109-0942
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, Estados Unidos, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Detroit, Michigan, Estados Unidos, 48201
        • Veterans Affairs Medical Center - Detroit
    • Ohio
      • Columbus, Ohio, Estados Unidos, 43210-1240
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

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 a 120 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

DISEASE CHARACTERISTICS:

  • Histologically confirmed gastric or gastroesophageal junction adenocarcinoma

    • Locally advanced unresectable or metastatic disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10mm by spiral CT scan

    • Bone metastases, ascites, or pleural effusions are not considered measurable disease
    • Evaluable disease must be present outside previously irradiated field
  • No CNS or brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • SWOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 mg/dL
  • No evidence of bleeding diathesis or coagulopathy

Hepatic

  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Bilirubin ≤ ULN
  • INR < 1.5

Renal

  • Creatinine < 2.0 mg/dL
  • Urine protein:creatinine ratio < 1.0

Cardiovascular

  • No history of deep venous thrombosis requiring anticoagulation
  • No active angina
  • No myocardial infarction within the past year
  • No cerebrovascular accident within the past year
  • No uncontrolled hypertension (systolic blood pressure [BP] > 170 mm Hg and/or diastolic BP > 100 mm Hg) despite medical management

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • No peripheral neuropathy > grade 1
  • No history of allergy to any of the study drugs or drugs formulated with polysorbate 80
  • No known HIV infection
  • No active peptic ulcer disease
  • No serious non-healing wound, ulcer, or bone fracture
  • No unresolved bacterial infection requiring antibiotics
  • No other active malignancy within the past 3 years except for cancers that have been treated with a curative intent

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent immunotherapy

Chemotherapy

  • No prior chemotherapy for gastric cancer unless disease relapsed > 6 months after completion of non-taxane adjuvant chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 3 weeks since radiotherapy

Surgery

  • At least 4 weeks since prior surgery or open biopsy (except indwelling venous catheter placement)
  • No concurrent surgery

Other

  • At least 4 weeks since prior and no concurrent participation in another experimental drug trial
  • No concurrent full-dose anticoagulation
  • No concurrent experimental drugs

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: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Docetaxel, Oxaliplatin & Bevacizumab
Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.
Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.
Outros nomes:
  • AvastinName
Must be administered 2nd after Bevacizumab and followed by Oxaliplatin.70 mg/m(2), IV over 60 minutes, day 1 of each cycle;
Outros nomes:
  • Taxotere
Must be administered 3rd after Bevacizumab and Docetaxel. 75 mg/m(2), IV over 120 minutes, Day 1 of each cycle.
Outros nomes:
  • Eloxatina

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Time to Progression
Prazo: After every 2 cycles (1 cycle =21 days) From study registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
After every 2 cycles (1 cycle =21 days) From study registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Response Rate by RECIST Criteria
Prazo: After every 2 cycles (1 cycle =21 days)
Percentage of Participants with response by RECIST criteria until progression
After every 2 cycles (1 cycle =21 days)
Toxicity Profile
Prazo: At 21 days following completion of study treatment
Toxicity profile of grade 3 and grade 4 events using the NCI-CTCAE Version 3.0 scale for toxicity grading.
At 21 days following completion of study treatment
Time to Treatment Failure
Prazo: Every 21 days From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Time to treatment failure using the Kaplan-Meier method
Every 21 days From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall Survival
Prazo: Patients will be followed for survival every three months after they are off study or until their disease progresses, for up to two years
Overall survival using the Kaplan-Meier method
Patients will be followed for survival every three months after they are off study or until their disease progresses, for up to two years

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Philip A. Philip, MD, PhD, FRCP, Barbara Ann Karmanos Cancer Institute
  • Investigador principal: Basil El-Rayes, MD, Barbara Ann Karmanos Cancer Institute

Publicações e links úteis

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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 (Real)

1 de outubro de 2004

Conclusão Primária (Real)

1 de novembro de 2012

Conclusão do estudo (Real)

1 de janeiro de 2013

Datas de inscrição no estudo

Enviado pela primeira vez

20 de setembro de 2005

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de setembro de 2005

Primeira postagem (Estimativa)

22 de setembro de 2005

Atualizações de registro de estudo

Última Atualização Postada (Real)

26 de março de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

13 de março de 2019

Última verificação

1 de março de 2019

Mais Informações

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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