- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00030420
Celecoxib and Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer
Evaluation Of Celecoxib In Combination With Docetaxel In The Treatment Of Advanced Non-Small Cell Lung Cancer Patients Previously Treated With Platinum Based Chemotherapy
RATIONALE: Celecoxib may slow the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with celecoxib may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining celecoxib and docetaxel in treating patients who have advanced non-small cell lung cancer that has been previously treated with platinum-based chemotherapy.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
OBJECTIVES:
- Determine the efficacy and feasibility of celecoxib combined with docetaxel in patients with advanced non-small cell lung cancer previously treated with platinum-based chemotherapy.
- Determine the response rate of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral celecoxib twice daily (beginning on day -7 of the first course) and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses after CR. Patients who achieve stable disease (SD) or a partial response (PR) receive a minimum of 2 additional courses after SD or PR. At the discretion of the treating physician, patients then receive maintenance therapy comprising celecoxib only.
Patients who discontinue therapy for disease progression or unacceptable toxicity are followed for at least 6 months.
PROJECTED ACCRUAL: A total of 21-39 patients will be accrued for this study within 13-28 months.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Michigan
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Detroit, Michigan, Estados Unidos, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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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 stage IIIA, IIIB, or IV non-small cell lung cancer
- Disease progression during or after 1 or more platinum-based chemotherapy regimens
- Measurable or evaluable disease
No symptomatic or untreated brain or leptomeningeal metastases
- Previously treated patients must be neurologically stable for 4 weeks after completion of appropriate therapy
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- SWOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 8 g/dL
Hepatic:
- Bilirubin no greater than upper limit of normal (ULN)
- AST/ALT no greater than ULN (or no greater than 2.5 times ULN if alkaline phosphatase no greater than ULN)
- Alkaline phosphatase no greater than ULN (or no greater than 5 times ULN if AST/ALT no greater than ULN)
- No history of chronic hepatitis of any duration
Renal:
- Creatinine no greater than ULN
Cardiovascular:
- No uncontrolled congestive heart failure
- No uncontrolled angina
- No myocardial infarction and/or stroke within the past 6 months
- No active thromboembolic event within the past 4 weeks
Gastrointestinal:
- No gastrointestinal bleeding within the past 6 months
- No history of peptic ulcer disease
Other:
- No prior hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- No prior allergy to any non-steroidal anti-inflammatory drug
- No other prior or concurrent malignancy within the past 3 years except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
- No grade 2 or greater peripheral neuropathy
- No active infection
- No other serious concurrent medical illness
- No history of dementia, active psychiatric disorder, or other condition that would interfere with ability to take oral medication or preclude compliance with study
- HIV negative
- Must weigh at least 50 kg (110 pounds)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
- Prior paclitaxel allowed
- No prior docetaxel
Endocrine therapy:
- At least 3 days since prior steroids
Radiotherapy:
- At least 4 weeks since prior radiotherapy
- No prior radiotherapy to target lesion
Surgery:
- At least 4 weeks since prior major surgery
Other:
- Prior intermittent use of non-steroidal anti-inflammatory drugs (NSAIDs), including rofecoxib or celecoxib, allowed
- At least 1 week since prior fluconazole
- No recent prior NSAIDs, including rofecoxib or celecoxib, for a duration of more than 30 consecutive days
- No concurrent fluconazole or lithium
- No other concurrent NSAIDs except aspirin administered at a dose of no more than 325 mg/day for cardiovascular conditions
- No other concurrent cyclo-oxygenase-2 inhibitors
- No other concurrent investigational agents
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Celecoxib & Docetaxel
Celecoxib: 400mg by mouth, twice a day, each dose given with meals, to start -7 days prior to first cycle of treatment. Doctaxel: Day 1, 75mg/m2 IV over 60 minutes, repeated every 21 days |
400mg by mouth, twice a day, each dose given with meals, to start -7 days prior to first cycle of treatment.
Outros nomes:
On day 1, 75mg/m2 IV over 60 minutes, repeated every 21 days
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Efficacy of combining Celecoxib with Docetaxel
Prazo: Weeks 1 , 2 and 3
|
Blood levels of VEGF & PGE2
|
Weeks 1 , 2 and 3
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Response rate of Celecoxib and Docetaxel
Prazo: Every 2 cycles (or every 42 days); After therapy is completed or if the patient is only on Celecoxib, will be assessed for progression every month by clinical exam and every 3 months by radiological evaluation.
|
CT Chest/Abdomen
|
Every 2 cycles (or every 42 days); After therapy is completed or if the patient is only on Celecoxib, will be assessed for progression every month by clinical exam and every 3 months by radiological evaluation.
|
Toxicity of Celecoxib and Docetaxel
Prazo: Every week
|
Routine bloodwork
|
Every week
|
Expression of cyclooxygenase-2 (COX-2) in tumors
Prazo: Pre-study
|
Tissue sample from initial diagnosis, parrafin embedded tissue block
|
Pre-study
|
Changes in plasma levels of prostaglandin E2 (PGE2) & vascular endthelial growth factor (VEGF)
Prazo: Pre-study; Weeks 1 , 2 and 3
|
Collecting blood plasma
|
Pre-study; Weeks 1 , 2 and 3
|
Vascular changes induced in the tumor by celecoxib
Prazo: Weeks 1, 3 & 6
|
Using DCE-MRI and PET scans to evaluate.
|
Weeks 1, 3 & 6
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
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
- Doenças Respiratórias
- Neoplasias
- Doenças pulmonares
- Neoplasias por local
- Neoplasias do Trato Respiratório
- Neoplasias Torácicas
- Carcinoma Broncogênico
- Neoplasias Brônquicas
- Neoplasias Pulmonares
- Carcinoma pulmonar de células não pequenas
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes do Sistema Nervoso Periférico
- Inibidores Enzimáticos
- Analgésicos
- Agentes do Sistema Sensorial
- Agentes anti-inflamatórios não esteróides
- Analgésicos, Não Narcóticos
- Antiinflamatórios
- Agentes Antirreumáticos
- Inibidores da Ciclooxigenase
- Agentes Antineoplásicos
- Moduladores de Tubulina
- Agentes Antimitóticos
- Moduladores de Mitose
- Inibidores da Ciclooxigenase 2
- Docetaxel
- Celecoxibe
Outros números de identificação do estudo
- CDR0000069164
- P30CA022453 (Concessão/Contrato do NIH dos EUA)
- WSU-C-2304 (Outro identificador: Barbara Ann Karmanos Cancer Institute)
- NCI-V01-1688
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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