- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00052728
Tipifarnib Plus Tamoxifen in Treating Women With Metastatic Breast Cancer
A Phase II Trial Of Tipifarnib (R15777, ZARNESTRA) In Combination With Tamoxifen In Subjects With Metastatic Breast Cancer
RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Tamoxifen may fight breast cancer by blocking the use of estrogen. Combining tipifarnib with tamoxifen may be effective treatment for metastatic breast cancer.
PURPOSE: This phase II trial is studying how well giving tipifarnib together with tamoxifen works in treating women with metastatic breast cancer.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
OBJECTIVES:
- Determine the maximum tolerated dose and recommended phase II dose of tipifarnib administered with tamoxifen in women with hormone receptor-positive metastatic breast cancer (Phase I closed to accrual effective 10/23/2003).
- Determine the acute and chronic toxicity of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the response rate and time to progression in patients treated with this regimen.
OUTLINE: This is an open-label study of tipifarnib (Phase I closed to accrual effective 10/23/2003). Patients are stratified according to benefit from prior hormonal therapy (yes vs no) (phase II).
- Phase I (closed to accrual effective 10/23/2003): Patients receive oral tipifarnib twice daily on days 1-21. Patients also receive oral tamoxifen daily on days 8-18 (during course I only) and on days 1-28 during all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tipifarnib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Once the MTD is determined, additional patients are accrued and treated at that dose level in the phase II portion of the study.
Patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 9-12 patients will be accrued for the phase I portion of this study (Phase I closed to accrual effective 10/23/2003). A total of 27-40 patients will be accrued for the phase II portion of this study within 3 years.
Tipo de estudo
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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Bethesda, Maryland, Estados Unidos, 20892
- NCI - Center for Cancer Research
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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:
- Diagnosis of metastatic (stage IV) breast cancer
- Evidence of disease progression
- Measurable disease
Must have been previously treated with at least 1 hormonal therapy with either an aromatase inhibitor or an estrogen receptor (ER)-modulating drug in the adjuvant or metastatic setting and meets 1 of the following criteria:
Hormone-responsive disease:
- Stable disease (no recurrence or progression for at least 6 months)
- Objective response
Hormone-nonresponsive disease:
- No stable disease
- No objective response
- Previously treated CNS disease allowed provided patient has a life expectancy of at least 3 months (phase I patients) (Phase I closed to accrual effective 10/23/2003)
- No CNS metastases (phase II patients)
Hormone receptor status:
- ER and/or progesterone receptor positive
- NOTE: As few as 1% positive cells considered positive
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Female
Menopausal status
- Not specified
Performance status
- Zubrod 0-1
Life expectancy
- See Disease Characteristics
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 2.0 mg/dL (unless evidence of Gilbert's disease)
- SGOT and SGPT less than 3 times upper limit of normal (unless liver involvement by tumor)
Renal
- Creatinine no greater than 1.5 mg/dL
Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective nonhormonal contraception during and for 2 months after study participation
- No medical or psychiatric condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
No more than 2 prior chemotherapy regimens for metastatic disease (phase II patients)
- No limitations on prior neoadjuvant or adjuvant regimens
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
Endocrine therapy
- See Disease Characteristics
- At least 6 months since prior tamoxifen
- Concurrent stable dose of steroids allowed (phase I patients) (Phase I closed to accrual effective 10/23/2003)
Radiotherapy
- No concurrent radiotherapy
Surgery
- Concurrent surgery allowed provided the need for surgery is not due to disease progression
Other
- Recovered from all prior therapy
- No prior warfarin
- No concurrent cytochrome p450-inducing anti-convulsants
- No other concurrent anticancer therapies
- Concurrent bisphosphonates for bone metastases allowed
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Mascaramento: Nenhum (rótulo aberto)
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: JoAnne Zujewski, MD, National Cancer Institute (NCI)
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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
- Agentes Antineoplásicos
- Hormônios, Substitutos Hormonais e Antagonistas Hormonais
- Agentes Antineoplásicos Hormonais
- Antagonistas Hormonais
- Agentes de Conservação da Densidade Óssea
- Antagonistas de Estrogênio
- Moduladores Seletivos de Receptores de Estrogênio
- Moduladores de Receptores de Estrogênio
- Tipifarnibe
- Tamoxifeno
Outros números de identificação do estudo
- CDR0000258720
- NCI-03-C-0037
- NCI-5540
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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