- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00674206
A Phase II Trial of Gemcitabine and Oxaliplatin for Triple Negative Metastatic Breast Cancer
A Phase II Trial of Gemcitabine and Oxaliplatin for ER-, PR-, HER2NEU- (Triple Negative) Metastatic Breast Cancer
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University Winship Cancer Institute
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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 ER-, PR-, Her2neu- (Triple Negative) metastatic breast cancer
- Patients must have measurable disease according to the RECIST criteria. Patients with bone metastases may be included if they have a decrease in performance status or narcotic analgesic requirement.
- Patients must have either received a taxane in the adjuvant setting or received a taxane as first-line treatment for metastatic breast cancer
- Age > 18 years
- ECOG Performance Score of 0, 1, or 2 (Appendix A)
- Adequate bone marrow as evidenced by:
- Absolute neutrophil count > 1,500/L
- Platelet count > 100,000/microL
- Adequate renal function as evidenced by serum creatinine < 1.5 mg/dL
Adequate hepatic function as evidenced by:
- Serum total bilirubin < 1.5 mg/dL
- Alkaline phosphatase < 3X the ULN for the reference lab < 5X the ULN (Upper limit for normal) for patients with known hepatic metastases
- SGOT/SGPT < 3X the ULN(Upper limit for normal) for the reference lab (< 5X the ULN for patients with known hepatic metastases
- Patients must be recovered from both acute and late effects of any prior surgery, radiotherapy or other antineoplastic therapy
- Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial.
- Patients of childbearing potential agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method)
Exclusion Criteria:
- Patients with an active infection or with a fever > 101.30 F within 3 days of the first scheduled day of protocol treatment
- Patients with active CNS metastases. Patients with stable CNS disease, who have undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment and who have been on a stable dose of corticosteroids for 3 weeks are eligible for the trial
- History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current PSA of < 1.0 mg/dL on 2 successive evaluations at least 3 months apart, with the most recent evaluation within 4 weeks of entry
- Patients with known hypersensitivity to any of the components of oxaliplatin or gemcitabine.
- Patients who have received gemcitabine or platin-based chemotherapy in the past.
- Patients who have received chemotherapy within 28 days of the first scheduled day of protocol treatment.
- Patients who received radiotherapy to more than 25% of their bone marrow; or patients who received any radiotherapy within 4 weeks of entry
- Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 28 days of the first scheduled day of protocol treatment (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
- Peripheral neuropathy Grade 2
- Patients who are pregnant or lactating
- Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
- History of allogeneic transplant
- Known HIV or Hepatitis B or C (active, previously treated or both)
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: Gemcitabine and Oxaliplatin
All patients enrolled on clinical trial will receive Gemcitabine 1000mg/m^2 on Day 1 and Oxaliplatin 100 mg/m^2 intravenously over 2 hours on Day 2.
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Gemcitabine 1000mg/m^2 on day 1 every 14 days Cycles of treatment will be repeated every 2 weeks until disease progression, intolerable toxicity, or the development of any of the criteria for study removal
Outros nomes:
Oxaliplatin 100mg/m^2 on day 2 every 14 days Cycles of treatment will be repeated every 2 weeks until disease progression, intolerable toxicity, or the development of any of the criteria for study removal
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Number of Participants With Complete Response, Partial Response, Progressive Disease and Stable Disease.
Prazo: 8 weeks
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A sum of the longest diameter(LD) for all target lesions will be calculated and reported as the baseline sum LD. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions. Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. |
8 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Overall Survival From Time of Study Entry
Prazo: 132 weeks
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The number of weeks patient survived from the time of patient entry. The time frame reflects the time the first patient was entered into the study to the time till the last patient survived. Note: Not all patients started the study at the same time so the time frame is different from the full range. The full range reflects the least number of weeks a patient survived to the most number of weeks a patient survived. |
132 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Amelia Zelnak, MD, Emory University Winship Cancer Institute
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
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças de pele
- Neoplasias
- Neoplasias por local
- Doenças da mama
- Neoplasias da Mama
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Anti-Infecciosos
- Antivirais
- Inibidores Enzimáticos
- Antimetabólitos, Antineoplásicos
- Antimetabólitos
- Agentes Antineoplásicos
- Agentes imunossupressores
- Fatores imunológicos
- Gemcitabina
- Oxaliplatina
Outros números de identificação do estudo
- IRB00007792
- 7792 (Other)
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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