- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00031993
Erlotinib in Treating Patients With Persistent or Recurrent Cancer of the Cervix
A Phase II Evaluation Of OSI-774 (NSC #718781) In The Treatment Of Persistent or Recurrent Squamous Cell Carcinoma Of The Cervix
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
PRIMARY OBJECTIVES:
I. To evaluate the antitumor cytostatic activity of OSI-774 as measured by the probability of surviving progression-free for at least 6 months in patients with persistent or recurrent squamous cell carcinoma of the cervix.
II. To determine the nature and degree of toxicity of OSI-774 in this cohort of patients.
SECONDARY OBJECTIVES:
I. To determine the partial and complete response rates in patients with squamous cell carcinoma of the cervix receiving OSI-774.
II. To determine the duration of progression-free survival and overall survival within this patient population treated with OSI-774.
III. Assess the effects of prognostic factors: initial performance status and age.
TERTIARY OBJECTIVES:
I. To determine epidermal growth factor receptor (EGFR) and p110 truncated EGFR (p110 sEGFR) isoform expression levels in primary tumors, and from tumor samples obtained pretreatment and following four weeks of therapy to determine tumor response (or resistance) to OSI-774 inhibition of the EGFR tyrosine kinase.
II. To correlate EGFR and p110sEGFR expression levels with either MAPK or AKT phosphorylation status in the same tissue samples obtained pretreatment and following four weeks of drug treatment to determine downstream effects with response to OSI-774 inhibition of EGFR.
III. To determine whether pretreatment serum p110 sEGFR concentrations are a useful prognostic indicator and whether altered and/or sEGFR concentrations are useful indicators of therapeutic responsiveness, time to progression, and overall survival in cervical carcinoma patients.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib once daily for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19103
- Gynecologic Oncology Group
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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:
Histologically confirmed squamous cell carcinoma (SCC) of the cervix
- Persistent or recurrent progressive disease
At least 1 prior systemic chemotherapy regimen for management of advanced, metastatic, or recurrent SCC of the cervix is required
- Chemotherapy administered as a radiosensitizer in conjunction with radiotherapy does not count as a systemic chemotherapy regimen
At least 1 unidimensionally measurable target lesion
- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- Lesions within a previously irradiated field are considered nontarget lesions unless disease progression or persistence is confirmed ≥ 90 days after completion of radiotherapy
- Tumor accessible for repeat needle biopsy
- Ineligible for a higher priority Gynecologic Oncology Group (GOG) protocol (any active GOG phase III protocol for the same patient population)
- Performance status - GOG 0-2 (for patients who have received only 1 prior regimen)
- Performance status - GOG 0-1 (for patients who have received 2 prior regimens)
- Platelet count at least 100,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Bilirubin no greater than upper limit of normal (ULN)
- SGOT no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
- Creatinine no greater than 1.5 times ULN
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No abnormalities of the cornea (e.g., dry eye syndrome or Sjogren's syndrome)
- No congenital abnormalities (e.g., Fuch's dystrophy)
- No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
- No abnormal corneal sensitivity test (Schirmer test or similar tear production test)
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- No uncontrolled concurrent illness
- No ongoing or active infection requiring IV antibiotics
- No psychiatric illness or social situation that would preclude study compliance
- No grade 2 or greater sensory or motor neuropathy
- No prior allergic reactions attributed to compounds of similar chemical or biological composition to erlotinib
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- At least 3 weeks since prior immunologic therapy for SCC of the cervix
- One additional prior cytotoxic chemotherapy regimen for recurrent or persistent disease allowed
- At least 3 weeks since prior chemotherapy for SCC of the cervix and recovered
- No prior non-cytotoxic chemotherapy for recurrent or persistent disease
- At least 3 weeks since prior hormonal therapy for SCC of the cervix
- At least 3 weeks since prior radiotherapy for SCC of the cervix and recovered
- Recovered from recent prior surgery
- At least 3 weeks since other prior therapy for SCC of the cervix
- No prior epidermal growth factor receptor-targeting therapies
- No prior anticancer treatment that would preclude study participation
- No other concurrent investigational or commercial agents or therapies for SCC of the cervix
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: Treatment (erlotinib hydrochloride)
Patients receive oral erlotinib once daily for 4 weeks.
Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
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Estudos correlativos
Dado PO
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Sobrevida livre de progressão
Prazo: Aos 6 meses
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Aos 6 meses
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Frequency and severity of adverse effects as measured by NCI CTC version 3.0
Prazo: Up to 5 years
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Up to 5 years
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Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Duration of overall survival
Prazo: Up to 5 years
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Up to 5 years
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Duration of progression-free survival
Prazo: Up to 5 years
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Up to 5 years
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Frequency of clinical response (complete and partial)
Prazo: Up to 5 years
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Up to 5 years
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Prognostic factors including initial performance status and age
Prazo: Up to 5 years
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Up to 5 years
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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
Termos MeSH relevantes adicionais
- Processos Patológicos
- Neoplasias por Tipo Histológico
- Neoplasias
- Neoplasias Glandulares e Epiteliais
- Atributos da doença
- Neoplasias de Células Escamosas
- Carcinoma
- Recorrência
- Carcinoma de Células Escamosas
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Agentes Antineoplásicos
- Inibidores de proteína quinase
- Cloridrato De Erlotinibe
Outros números de identificação do estudo
- NCI-2012-02457
- U10CA027469 (Concessão/Contrato do NIH dos EUA)
- GOG-0227D
- CDR0000069247 (Identificador de registro: PDQ (Physician Data Query))
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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