- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00064610
Phase I/II Dose Escalation Study of VELCADE® and Docetaxel in Patients With Advanced Androgen-Independent Prostate Cancer
A Phase I/II, Open Label, Dose Escalation Study to Determine the Tolerance and Preliminary Activity of PS-341 Plus Docetaxel in Patients With Advanced Androgen-Independent Prostate Cancer Requiring Chemotherapy
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Locais de estudo
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California
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Los Angeles, California, Estados Unidos, 90048
- Cedars Sinai Medical Center
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New York
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New York, New York, Estados Unidos, 10032
- Columbia-Presbyterian Hospital
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Foundation
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt University Medical Center
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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
Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Patient has histologically-confirmed advanced and/or metastatic androgen-independent prostate cancer requiring anti-neoplastic treatment.
- Previous or concurrent hormone therapy with a luteinizing hormone-releasing hormone analog (e.g., leuprolide) does not preclude enrollment in the study.
Patient has progressive measurable or evaluable disease, defined as meeting at least one of the following three criteria [1]:
- Progressive measurable disease (changes in the size of lymph nodes or parenchymal masses on physical examination or x-ray).
- Progressive bone metastasis [presence of new lesion(s) on a bone scan].
Progressive PSA, as evidenced by two separate measurements taken at least one week apart and confirmed by a third, and if necessary, a fourth measurement.
- If the third measurement is not greater than the second measurement, then a fourth measurement must be taken; the fourth measurement must be greater than the second measurement for the patient to be eligible for enrollment in the study.
- The confirmatory PSA measurement (i.e., the third or, if applicable, fourth PSA measurement) must be greater than or equal to 5 ng/mL.
- Patient is 18 years of age or older.
- Patient has a Karnofsky performance status of 60% or greater.
- Patient has a life expectancy of three months or longer.
- Patient has all of the following pretreatment laboratory data within 14 days before the first study drug dose:
- Absolute neutrophil count (ANC) greater than or equal to 1,500/mm3.
- Platelets greater than or equal to100,000/mm3.
- Hemoglobin >8.0 g/dL.
- Serum creatinine less than or equal to 2.5 mg/dL.
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care.
- Patient agrees to use an acceptable barrier method for contraception from Screening through 90 days after the last study drug dose. [It is recommended that female partners of male patients enrolled in this study also use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence).]
Exclusion criteria Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
- Patient has received chemotherapy within four weeks, nitrosoureas within six weeks, or antibody therapy within eight weeks of enrollment.
- Patient has received radiation therapy within four weeks of enrollment.
- Patient has not recovered from all toxic effects of previous chemotherapy or radiation or antibody therapy.
- Patient received treatment with flutamide within four weeks of enrollment or nilutamide or bicalutamide within six weeks of enrollment.
- Patient has had any major surgery within four weeks of enrollment.
- Patient has a history of allergic reactions to diuretics or anti-emetics suggested to be administered in conjunction with study drug
- Patient has a history of severe hypersensitivity reaction to docetaxel or other agents formulated with polysorbate 80.
- Patient had a myocardial infarction within six months of enrollment or has uncontrolled angina, severe uncontrolled ventricular arrhythmias, symptomatic congestive heart failure, unstable angina pectoris, or electrocardiographic evidence of acute ischemia
- Patient has uncontrolled brain metastases or central nervous system disease.
- Patient has Grade 2 or higher peripheral neuropathy
Patient has any of the following pretreatment laboratory data within 14 days before the first study drug dose:
- Total bilirubin > than the upper limit of normal (ULN).
- Alanine transaminase (ALT) and/or aspartate transaminase (AST) >1.5 x the ULN concurrent with alkaline phosphatase >2.5 x the ULN.
- Alkaline phosphatase >5 x the ULN, unless shown by fractionation to be bone-derived and AST, ALT, bilirubin, gamma glutamyl transferase (GGT), and 5'nucleotidase are <1.5 x the ULN and bilirubin is within normal range.
- Serum testosterone 50 ng/mL or higher.
- Patient is HIV-infected.
- Patient is hepatitis B surface antigen positive or has previously documented hepatitis C infection.
- Patient has an uncontrolled intercurrent illness (e.g., active infection).
- Patient has another serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (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
- M34101-033
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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