- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00020904
BMS-247550 in Treating Women With Metastatic Breast Cancer
A Phase II Study of Epothilone B Analog BMS-247550 in Patients With Taxane-Resistant Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating women who have stage IV or recurrent metastatic breast cancer.
Visão geral do estudo
Descrição detalhada
OBJECTIVES:
- Determine the clinical activity of BMS-247550, in terms of tumor response rate, in women with taxane-resistant metastatic breast cancer.
- Determine the safety of this drug in these patients.
- Determine the duration of response, time to progression, and survival of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive BMS-247550 IV over 3 hours on day 1. Treatment continues every 3 weeks for 4-18 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 4 additional courses beyond CR. Responding patients may receive additional courses at the investigator's discretion.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 14-50 patients will be accrued for this study within 12 months.
Tipo de estudo
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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New York
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New York, New York, Estados Unidos, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Estados Unidos, 10032
- Herbert Irving Comprehensive Cancer Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed metastatic breast carcinoma
- Stage IV or recurrent disease with distant metastases
Most recent prior chemotherapy was docetaxel-based or paclitaxel-based therapy for metastatic disease
- Progressed during therapy or within 4 months of last dose OR
- Progressed during therapy or within 6 months of last dose if given as adjuvant treatment only
- Received prior anthracycline therapy
Bidimensionally measurable metastatic lesion
- Bony lesions not considered measurable
- No known brain metastases
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Menopausal status:
- Not specified
Sex:
- Female
Performance status:
- ECOG 0-1
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count greater than 125,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- ALT no greater than 2.5 times ULN (5 times ULN if hepatic metastases are present)
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No unstable angina, myocardial infarction, or congestive heart failure within the past 6 months
Other:
- No grade 2 or greater neuropathy (motor or sensory)
- No uncontrolled infection or other medical illness that would preclude study
- No psychiatric disorder or other condition that would preclude study
- No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No hypersensitivity to agents containing Cremophor EL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 24 hours since prior growth factor
- No concurrent trastuzumab (Herceptin)
- No concurrent immunotherapy
Chemotherapy:
- See Disease Characteristics
- No more than 1 prior chemotherapy regimen for metastatic disease except an anthracycline-containing regimen as first-line therapy and a taxane as second-line therapy
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy (except hormone replacement therapy)
Radiotherapy:
- At least 3 weeks since prior radiotherapy, except palliative radiotherapy to less than 20% of the bone marrow, and recovered
- No prior radiotherapy to major bone marrow-containing areas (pelvis and lumbar spine)
- No prior radiotherapy to target lesion if only measurable lesion
- No concurrent therapeutic radiotherapy
Surgery:
- At least 1 week since prior minor surgery
- At least 3 weeks since prior major surgery
- Recovered from prior surgery
Other:
- Recovered from all prior treatment-related toxic effects (alopecia allowed)
- No other concurrent experimental anticancer medications
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Clifford A. Hudis, MD, Memorial Sloan Kettering Cancer Center
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
Outros números de identificação do estudo
- 01-031
- CDR0000068729 (Identificador de registro: PDQ (Physician Data Query))
- BMS-CA163-009
- CPMC-IRB-13916
- NCI-G01-1967
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