- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00253565
Imatinib Mesylate and Capecitabine in Treating Patients With Advanced Solid Tumors
A Phase I Dose Escalation Study of Imatinib Mesylate (Gleevec/STI571) Plus Capecitabine (Xeloda) in Advanced Solid Tumor Malignancies
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imatinib mesylate together with capecitabine may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate when given together with capecitabine in treating patients with advanced solid tumors.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and recommended phase II dose of imatinib mesylate when administered with capecitabine in patients with advanced malignant solid tumors.
Secondary
- Determine the non-dose-limiting toxic effects of this regimen in these patients.
- Determine, preliminarily, the clinical activity of this regimen in these patients.
- Determine the pharmacokinetics and pharmacogenetics of this regimen in these patients.
- Determine, preliminarily, the effect of this regimen on wound angiogenesis in these patients.
- Correlate pharmacokinetic parameters with clinical toxicity, clinical activity, or surrogate biomarker activity of this regimen in these patients.
OUTLINE: This is a dose escalation study of imatinib mesylate.
Patients receive oral capecitabine twice daily on days 1-14 and oral imatinib mesylate once or twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of patients receive escalating doses of imatinib mesylate until the maximum tolerated dose is determined.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke 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 confirmed malignant solid tumors for which no standard effective therapy exists OR such therapy is refused
- Previously treated brain metastases that are currently asymptomatic allowed
PATIENT CHARACTERISTICS:
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 2,000/mm^3
- Platelet count > 100,000 mm^3
- Hemoglobin > 9.0 g/dL
Hepatic
- Alkaline phosphatase < 2.5 times upper limit of normal (ULN)
- SGOT and SGPT < 2.5 times ULN
- Bilirubin < 1.5 times ULN
Renal
- Creatinine clearance > 50 mL/min
Cardiovascular
- No congestive heart failure
- No symptomatic coronary artery disease
- No uncontrolled cardiac arrhythmias
- No myocardial infarction within the past 12 months
- No other clinically significant cardiac disease
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- No prior unanticipated severe reaction to fluoropyrimidine therapy
- No known sensitivity to fluorouracil
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 28 days since prior biologic therapy
Chemotherapy
- More than 28 days since prior chemotherapy (42 days for nitrosoureas or mitomycin C)
Endocrine therapy
- At least 90 days since prior steroids for the treatment of brain metastases
- More than 28 days since prior hormonal therapy
Radiotherapy
- At least 90 days since prior radiotherapy for the treatment of brain metastases
- More than 28 days since other prior radiotherapy
- No prior pelvic radiotherapy > 30% of the bone marrow
Surgery
- More than 28 days since prior surgery and recovered
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Herbert I. Hurwitz, MD, Duke Cancer Institute
Publicações e links úteis
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
- Pro00009521
- DUMC-3992-05-8R3
- ROCHE-DUMC-3992-05-8R3
- NOVARTIS-DUMC-3992-05-8R3
- CDR0000448905 (Outro identificador: NCI)
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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