- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00369655
VEGF Trap in Treating Patients With Metastatic Breast Cancer
Phase II Trial of VEGF Trap in Patients With Metastatic Breast Cancer Previously Treated With Anthracycline and/or Taxane
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
PRIMARY OBJECTIVES:
I. Assess the antitumor activity of VEGF Trap, in terms of tumor response rate, in patients with metastatic breast cancer who have received =< 2 prior chemotherapy regimens for metastatic disease, including a taxane and/or anthracycline.
II. Assess the 6-month progression-free survival rate in patients treated with VEGF Trap.
SECONDARY OBJECTIVES:
I. Describe the adverse event profile (grade using the NCI CTCAE version 3.0) of VEGF Trap in these patients.
II. Describe the progression-free survival times in patients treated with VEGF Trap.
III. Describe the overall survival of patients treated with VEGF Trap. IV. Describe the duration of response in patients treated with VEGF Trap.
OUTLINE: This is a multicenter study.
Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3-6 months for up to 5 years.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- North Central Cancer Treatment Group
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
Histologically or cytologically confirmed adenocarcinoma of the breast
- Clinical evidence of metastatic disease
No more than 2 prior chemotherapy regimens for metastatic disease
- Prior neoadjuvant or adjuvant chemotherapy allowed*
- At least 1 prior regimen (in any setting) must have included a taxane and/or an anthracycline
Measurable disease, defined as ≥ 1 lesion whose longest diameter can be accurately measured per RECIST criteria
No nonmeasurable disease, defined as all other lesions, including small lesions(longest diameter < 20 mm) and truly nonmeasurable lesions, including the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Patients with HER2-positive tumors (3+ by immunohistochemistry or amplified by fluorescent in situ hybridization [FISH]) must have received ≥ 1 prior trastuzumab (Herceptin®)-containing regimen in either the adjuvant or metastatic setting, unless there was a contraindication
- No known CNS metastases
- No evidence of leptomeningeal involvement
- Hormone receptor status not specified
- Male or female
- Menopausal status not specified
- ECOG performance status 0-1
- Life expectancy > 3 months
- WBC ≥ 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 75,000/mm³
- Hemoglobin > 8.0 g/dL
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3 times ULN
- AST and ALT ≤ 2.5 times ULN
- Creatinine ≤ 1.5 times ULN
- Urine protein:creatinine ratio < 1 OR urine protein < 500 mg by 24-hour urine collection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- No significant traumatic injury within the past 4 weeks
- No history of allergy or hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies, drug product excipients, or agents chemically or biologically similar to VEGF Trap
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
- No nonhealing wound, fracture, or ulcer
- No stage III or IV invasive, nonbreast malignancy within the past 5 years
- No history of lung carcinoma of squamous cell type
No clinically significant cardiovascular disease, including any of the following:
- Cerebrovascular accident or stroke within the past 6 months
- Uncontrolled hypertension, defined as blood pressure (BP) > 150/100 mm Hg OR systolic BP > 180 mm Hg if diastolic blood pressure < 90 mm Hg on ≥ 2 separate occasions within the past 3 months
- Myocardial infarction, coronary artery bypass graft, or unstable angina within the past 6 months
- New York Heart Association class III or IV cardiovascular disease
- Serious cardiac arrhythmia requiring medication
- Peripheral vascular disease ≥ grade 2 within the past 6 months
- Pulmonary embolism, deep vein thrombosis, or other thromboembolic event within the past 6 months
- No evidence of bleeding diathesis or uncontrolled coagulopathy
- No active, unresolved infection
- No serious concurrent medical condition that would preclude study participation
- No other condition or circumstance that would preclude compliance with study requirements
- See Disease Characteristics
- Prior hormonal therapy in the neoadjuvant, adjuvant, or metastatic setting allowed
- No prior bevacizumab
- More than 4 weeks since prior chemotherapy, endocrine therapy, experimental drug therapy, or immunotherapy and recovered
- More than 4 weeks since prior major surgery or open biopsy
- More than 7 days since prior core biopsy
More than 2 weeks since prior radiotherapy, except if to a nontarget lesion only
- Prior radiotherapy to a target lesion allowed only if there has been clear progression of the lesion since radiotherapy was completed
- Prior single-dose palliative radiotherapy within the past 2 weeks allowed
- No concurrent major surgery
- No concurrent trastuzumab
Concurrent full-dose anticoagulants (e.g., warfarin) with PT INR > 1.5 allowed provided the following criteria are met:
- INR in-range (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
- No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No concurrent participation in another investigational clinical trial
- No other concurrent chemotherapeutic agents, endocrine therapy, biologic agents, radiotherapy, or other nonprotocol antitumor therapy
Plano de estudo
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 |
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Experimental: Treatment (ziv-afibercept)
Patients receive VEGF Trap IV over 1 hour on day 1.
Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
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Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Proportion of Patients With Confirmed Tumor Response
Prazo: Up to 5 years
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Confirmed tumor response was defined as the total number of efficacy-evaluable patients who achieved a complete or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria on 2 consecutive evaluations at least 8 weeks apart.
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Up to 5 years
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Proportion of Patients Receiving Vascular Endothelial Growth Factor (VEGF) Trap With 6-month Progression-free Survival
Prazo: 6 months
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The 6-month progression free survival rate was defined as the proportion of efficacy-evaluable patients on study treatment and progression-free 6 months from registration.
Patients who died without documentation of progression will be considered to have progressed on the date of their death.
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6 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Progression Free Survival
Prazo: Time from registration to disease progression or death (up to 5 years)
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Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who died without documentation of progression being considered to have progressed on the date of their death.
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Time from registration to disease progression or death (up to 5 years)
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Overall Survival
Prazo: Time from registration to death or last follow up (up to 5 years)
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Overall survival time was defined as the number of months from registration to the date of death or last follow-up
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Time from registration to death or last follow up (up to 5 years)
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Median Duration of Response
Prazo: Up to 5 years
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Duration of response was defined as for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a complete response or partial response to the date progression is documented.
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Up to 5 years
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Number of Participant With Previous Treatment of Anti-HER2 With Cardiac Events
Prazo: Up to 5 years
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Up to 5 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Edith Perez, North Central Cancer Treatment Group
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NCI-2012-01827
- U10CA025224 (Concessão/Contrato do NIH dos EUA)
- NCCTG-N0537
- CDR0000491314 (Identificador de registro: PDQ (Physician Data Query))
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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