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Bevacizumab or Cetuximab And Gemcitabine Hydrochloride, Capecitabine, and Radiation Therapy in Treating Patients With Pacreatic Cancer That Has Been Completely Removed By Surgery

6 de maio de 2014 atualizado por: National Cancer Institute (NCI)

An Intergroup Randomized Phase II Study of Bevacizumab (NSC 704865) or Cetuximab (NSC 714692) in Combination With Gemcitabine and in Combination With Chemoradiation (Capecitabine and Radiation) in Patients With Completely-Resected Pancreatic Carcinoma

This randomized phase II trial is studying bevacizumab to see how well it works compared to cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in treating patients with pancreatic cancer that has been completely removed by surgery. Monoclonal antibodies, such as bevacizumab and cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help 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. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab or cetuximab together with gemcitabine, capecitabine, and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether bevacizumab is more effective than cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in treating pancreatic cancer.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

PRIMARY OBJECTIVES:

I. To describe the toxicity profile of cetuximab and bevacizumab when combined with gemcitabine, before and after capecitabine plus radiation and during capecitabine plus radiation in patients with completely-resected pancreatic carcinoma in the adjuvant setting.

II. To assess the safety profile of either cetuximab or bevacizumab plus gemcitabine in patients with resected pancreatic cancer.

III. To obtain tissue specimens from resections of patients enrolled on study for correlative studies and further evaluations.

SECONDARY OBJECTIVES:

I. To evaluate disease-free and overall survival for patients receiving either cetuximab or bevacizumab in combination with gemcitabine before and after capecitabine plus radiation.

II. To assess the safety profile for patients receiving either capecitabine plus cetuximab plus radiation, or capecitabine plus bevacizumab plus radiation.

III. To correlate changes in serum amphiregulin and TGF alpha to survival, DFS and rash for patients receiving cetuximab.

IV. To determine the 2-year survival rate for patients receiving either cetuximab plus gemcitabine before and after capecitabine plus cetuximab plus radiation, or bevacizumab plus gemcitabine before and after capecitabine plus bevacizumab plus radiation.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to degree of prior resection of the pancreatic tumor (R0 vs R1). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).

Arm II: Patients receive bevacizumab IV over 60-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, and 23. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in arm I.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 3 years.

Tipo de estudo

Intervencional

Inscrição (Real)

137

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

  • Estados Unidos
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215
        • Eastern Cooperative Oncology Group

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:

  • Patients must have histologically or cytologically confirmed evidence of pancreatic carcinoma
  • Patients must have had all gross disease resected (R0 or R1 resection)
  • Patients undergoing an R2 resection are not eligible
  • Patients must have had no prior chemotherapy or radiation therapy for pancreatic cancer and must have had no prior EGFR/VEGF inhibition
  • Patient must have ECOG performance status of 0-2
  • Leukocytes >= 3,000/μL
  • ANC >= 1,500/μL
  • Platelets >= 100,000/μL
  • Total bilirubin Within normal institutional limits
  • AST (SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal
  • Creatinine clearance >= 60 mL/min for patients with creatinine levels above institutional normal
  • Patients must be > 4 weeks and =< 8 weeks post-surgery at time of study registration (may be up to 10 weeks post-surgery prior to start of study therapy)
  • Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception prior to study entry
  • Women must not be pregnant or breast-feeding; all agents used in this study as well as radiation therapy to the abdomen have the potential for teratogenic or abortifacient effects; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
  • Patients must not be receiving any other investigational agents
  • Patients with known metastases are not eligible
  • Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to cetuximab, bevacizumab or other agents used in the study are not eligible
  • Patients with wounds that have not fully healed are not eligible
  • Patients must not have cardiac arrhythmia
  • Patients must have no known HIV infection
  • Patients must not have any of the following: acinar cell carcinoma, neuroendocrine carcinoma, cystadenocarcinoma, carcinosarcoma
  • Patients with psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude them from meeting the study requirements are not eligible
  • Patients requiring full dose anticoagulation are not eligible
  • Patients with a history of transient ischemic attack (TIA) or cerebrovascular accident (CVA) are not eligible

  • Patients with a history of the following within twelve months of study entry are not eligible:

    • Arterial thrombembolic events
    • Unstable angina
    • Myocardial infarction

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: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Arm I (cetuximab, gemcitabine, capecitabine, radiation)
Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
Outro: análise laboratorial de biomarcadores
Estudos correlativos
Medicamento: cloridrato de gemcitabina
Dado IV
Outros nomes:
  • Gemzar
  • gemcitabina
  • dFdC
  • cloridrato de difluorodesoxicitidina
Biológico: cetuximabe
Dado IV
Outros nomes:
  • C225
  • IMC-C225
  • Anticorpo monoclonal C225
  • MOAB C225
  • anticorpo monoclonal C225
Medicamento: capecitabina
Dado oralmente
Outros nomes:
  • Xeloda
  • CAPA
  • Ro 09-1978/000
Radiação: radioterapia
Fazer radioterapia
Outros nomes:
  • irradiação
  • radioterapia
  • terapia, radiação
Experimental: Arm II (bevacizumab, gemcitabine, capecitabine, radiation)
Patients receive bevacizumab IV over 60-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, and 23. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in arm I.
Outro: análise laboratorial de biomarcadores
Estudos correlativos
Biológico: bevacizumabe
Dado IV
Outros nomes:
  • AvastinName
  • anticorpo monoclonal humanizado anti-VEGF
  • anticorpo monoclonal anti-VEGF
  • rhuMAb VEGF
Medicamento: cloridrato de gemcitabina
Dado IV
Outros nomes:
  • Gemzar
  • gemcitabina
  • dFdC
  • cloridrato de difluorodesoxicitidina
Medicamento: capecitabina
Dado oralmente
Outros nomes:
  • Xeloda
  • CAPA
  • Ro 09-1978/000
Radiação: radioterapia
Fazer radioterapia
Outros nomes:
  • irradiação
  • radioterapia
  • terapia, radiação

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Proportion of Patients With Specific Protocol Defined Adverse Event at Conclusion of All Therapy
Prazo: Every 2 weeks while on treatment and for 30 days after the end of treatment

Specific toxicities to be monitored pursuant to the primary endpoint include:

  1. Any grade 5 toxicities
  2. Grade 4 dyspnea, neutropenic fever, allergic reaction, rash, wound dehiscence, wound infection, hypertension
  3. Grade 3 or higher arterial thromboembolic phenomena, bleeding, phlebitis/deep vein thrombosis (DVT)/pulmonary embolism (PE), hemorrhage, ileus, bowel perforation, diarrhea, and mucositis
  4. ECOG performance status decline by 2 or greater for >24 hours
  5. Weight loss >10%
Every 2 weeks while on treatment and for 30 days after the end of treatment

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Two-year Overall Survival Rate
Prazo: Assessed every 3 months for 2 years
Overall survival (OS) is defined as the time from randomization to death from any cause, or censored at last known date of survival.
Assessed every 3 months for 2 years
Two-year Disease-free Survival (DFS)
Prazo: Assessed every 3 months for 2 years, and every 6 months after completion of treatment for 2 years, then annually for 3 years
Disease-free survival (DFS) is defined as the time from randomization to the first treatment failure (recurrence or death before recurrence).
Assessed every 3 months for 2 years, and every 6 months after completion of treatment for 2 years, then annually for 3 years

Colaboradores e Investigadores

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

Patrocinador

National Cancer Institute (NCI)

Investigadores

  • Investigador principal: Jordan Berlin, Eastern Cooperative Oncology Group

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 fevereiro de 2006

Conclusão Primária (Real)

1 de julho de 2008

Conclusão do estudo (Real)

1 de fevereiro de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

21 de março de 2006

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de março de 2006

Primeira postagem (Estimativa)

22 de março de 2006

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

21 de maio de 2014

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de maio de 2014

Última verificação

1 de dezembro de 2012

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • NCI-2012-02969 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
  • U10CA021115 (Concessão/Contrato do NIH dos EUA)
  • CALGB-ECOG-E2204
  • SWOG-ECOG-E2204
  • ECOG-E2204
  • NCCTG-ECOG-E2204
  • E2204 (Outro identificador: CTEP)

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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