Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
Single Center Open-Label Non-Comparative Phase I Dose Finding Study Of Weekly Flavopiridol In Combination With Weekly Docetaxel In Patients With Advanced Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining flavopiridol with docetaxel in treating patients who have advanced solid tumors.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
OBJECTIVES:
- Determine the maximum tolerated dose of flavopiridol when administered in combination with 2 different doses of docetaxel in patients with advanced solid tumors.
- Determine the clinical pharmacokinetics of this regimen in these patients.
- Determine, preliminarily, the therapeutic activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of flavopiridol.
Patients receive docetaxel IV over 30 minutes followed at least 4 hours later by flavopiridol IV over 1 hour on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Separate MTDs of flavopiridol are determined when flavopiridol is combined with 2 different doses of docetaxel. A total of 10 patients are treated at each flavopiridol MTD.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 6-56 patients will be accrued for this study.
Tipo de estudo
Estágio
- Fase 1
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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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
DISEASE CHARACTERISTICS:
- Histologically confirmed advanced solid tumor that is refractory to standard therapy or for which no standard therapy exists
- Measurable or evaluable disease
- No symptomatic or untreated CNS metastases or primary CNS neoplasm
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,500/mm3
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 8 g/dL
Hepatic
- Bilirubin no greater than upper limit of normal (ULN)
- SGOT/SGPT no greater than 2.5 times ULN if alkaline phosphatase no greater than ULN OR
- Alkaline phosphatase no greater than 2.5 times ULN if SGOT/SGPT no greater than ULN
Renal
- Creatinine no greater than 1.5 mg/dL
Cardiovascular
- No history of cardiac arrhythmias
- No congestive heart failure
- No myocardial infarction within the past 6 months
Other
- No concurrent serious or uncontrolled infection
- No diabetes not adequately controlled with medication
- No peripheral neuropathy greater than grade 1
- No known allergy to docetaxel or other medications formulated in Polysorbate 80
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 4 weeks since prior immunotherapy
Chemotherapy
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- Prior taxanes allowed
- No prior flavopiridol
Endocrine therapy
- At least 4 weeks since prior hormonal therapy
Radiotherapy
- At least 4 weeks since prior radiotherapy
Surgery
- Not specified
Other
- Recovered from prior therapy
- No prior enrollment in this study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
Colaboradores e Investigadores
Patrocinador
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
- Neoplasias
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Agentes Antineoplásicos
- Moduladores de Tubulina
- Agentes Antimitóticos
- Moduladores de Mitose
- Substâncias de crescimento
- Inibidores de crescimento
- Inibidores de proteína quinase
- Docetaxel
- Alvocidibe
Outros números de identificação do estudo
- AVENTIS-HMR1275A/1501
- MSKCC-02034
- NCI-G02-2106
- CDR0000256563 (Identificador de registro: PDQ (Physician Data Query))
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