- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00093496
Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Recurrent Advanced Ovarian Epithelial or Peritoneal Cavity Cancer
A Phase II Trial Of Gemcitabine in Combination With 17-Allylaminogeldamycin (17-AAG) In Advanced Epithelial Ovarian And Primary Peritoneal Carcinoma
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
OBJECTIVES:
I. Determine the response rate, time to progression, and survival of patients with recurrent advanced ovarian epithelial or primary peritoneal cavity cancer treated with gemcitabine hydrochloride and 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) (tanespimycin).
II. Determine the toxicity of this regimen in these patients. III. Correlate the effect of 17-AAG alone on chaperone and client proteins in tumor samples and peripheral blood mononuclear cells with response, time to progression, and survival of these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to gemcitabine hydrochloride therapy (gemcitabine hydrochloride-naive/no prior exposure to gemcitabine hydrochloride vs gemcitabine hydrochloride-resistant/prior exposure to gemcitabine hydrochloride as a single agent with disease progression while on treatment). Patients receive tanespimycin intravenously (IV) over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic
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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:
Diagnosis of ovarian epithelial or primary peritoneal cavity cancer
- Relapsed disease
- Persistent disease
Platinum-resistant disease, defined as having evidence of disease that would be expected to be non-responsive to additional platinum-containing regimens or contraindication to platinum-based chemotherapy and 1 of the following:
- Failure to obtain a complete response to initial platinum therapy
- Recurrence < 6 months after completing a platinum-containing regimen for initial or recurrent disease
- Any of the above situations and following treatment with additional chemotherapy regimens (e.g., non-platinum containing regimens)
- Relative or absolute contraindication to platinum-based chemotherapy regimens (e.g., platinum allergy) as determine by the investigator
Measurable or evaluable disease
- Patients with a rising CA 125 level, even in the absence of other indicators of disease, allowed provided CA 125 is ≥ 2 times upper limit of normal (ULN)
- Patients with accessible disease must be willing to undergo tumor biopsies
- No CNS metastases
- Performance status - ECOG 0-2
- WBC ≥ 3,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9.0 g/dL
- Bilirubin normal
- Alkaline phosphatase ≤ 2.5 times ULN
- AST ≤ 2.5 times ULN
- Creatinine ≤ 1.5 times ULN
- Ejection fraction > 40% by ECHO for patients with prior anthracycline therapy
No significant cardiac disease including any of the following:
- New York Heart Association class III or IV heart disease
- History of myocardial infraction within the past year
- Uncontrolled dysrhythmias or requirement for antiarrhythmic drugs
- Poorly controlled angina
- No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
- No history of QTc ≥ 500 msec
- No active ischemic heart disease within the past 12 months
- No congenital long QT syndrome
- No left bundle branch block
- No cardiac symptoms ≥ grade 2
- No history of cardiac toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone, bleomycin, or carmustine)
- Does not meet the medicare criteria for home oxygen
- No pulse oximetry at rest and exercise < 88%
No symptomatic pulmonary disease requiring medication including any of the following:
- Dyspnea on or off exertion
- Paroxysmal nocturnal dyspnea
- Oxygen requirement
- Significant pulmonary disease (e.g., chronic obstructive/restrictive pulmonary disease)
- No pulmonary symptoms ≥ grade 2
- No history of pulmonary toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone, bleomycin, or carmustine)
- K+, Mg ++, and Ca ++ normal
- No seizure disorder
- No uncontrolled infection
- No history of serious allergic reaction to eggs
- More than 4 weeks since prior immunotherapy
- More than 4 weeks since prior biologic therapy
- No concurrent immunotherapy
- No concurrent routine or prophylactic colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
- See Disease Characteristics
- More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
Prior gemcitabine hydrochloride allowed provided 1 of the following criteria is met:
- Patients have no prior exposure to gemcitabine hydrochloride
- Patients who have prior exposure to gemcitabine hydrochloride as a single agent have experienced progressive disease while on treatment
- No other concurrent chemotherapy
- No prior radiotherapy to > 25% of bone marrow
No history of radiotherapy that potentially included the heart in the field (e.g., mantle)
- Chest wall irradiation or other radiotherapy techniques that do not include the heart in the radiation field area allowed
- More than 4 weeks since prior radiotherapy
- More than 4 weeks since prior radiopharmaceuticals
- No concurrent radiotherapy
- No other concurrent investigational therapy
- No concurrent medications that may prolong QTc
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 |
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Experimental: Treatment (chemotherapy)
Patients are stratified according to gemcitabine hydrochloride therapy (gemcitabine hydrochloride-naive/no prior exposure to gemcitabine hydrochloride vs gemcitabine hydrochloride-resistant/prior exposure to gemcitabine hydrochloride as a single agent with disease progression while on treatment).
Patients receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
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Dado IV
Outros nomes:
Dado IV
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Proportion of Patients Who Experience a Confirmed Response According to Modified RECIST Criteria.
Prazo: Participants were evaluated every 6 weeks on treatment, with median treatment length of 12 weeks (3 week minimum and 42 week maximum).
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Objective response will be measured using the modified RECIST criteria. A confirmed response requires an objective status of complete or partial response on 2 consecutive evaluations occurring 4 or more weeks apart. Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers. Partial Response (PR): At least a 30% decrease in the sum of the target lesions from the baseline. |
Participants were evaluated every 6 weeks on treatment, with median treatment length of 12 weeks (3 week minimum and 42 week maximum).
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Times to Progression
Prazo: Participants were evaluated every 6 weeks on treatment (maximum 42 weeks), and followed up to 5 years from registration.
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Defined as the time from registration to the date of progression or last follow-up, whichever comes first.
Estimated using the method of Kaplan-Meier
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Participants were evaluated every 6 weeks on treatment (maximum 42 weeks), and followed up to 5 years from registration.
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Overall Survival
Prazo: Every 3 months until disease progression and then every 6 months for up to 5 years.
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Defined as the time from registration to date of last follow-up or death due to any cause.
Estimated using the method of Kaplan-Meier.
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Every 3 months until disease progression and then every 6 months for up to 5 years.
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Toxicity
Prazo: Participants were evaluated every 6 weeks on treatment (maximum 42 weeks)
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Defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 as an adverse event classified as either possibly, probably, or definitely related to study treatment.
The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
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Participants were evaluated every 6 weeks on treatment (maximum 42 weeks)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Paul Haluska, Mayo Clinic
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
Termos MeSH relevantes adicionais
- Doenças do aparelho digestivo
- Neoplasias por Tipo Histológico
- Neoplasias
- Neoplasias urogenitais
- Neoplasias por local
- Carcinoma
- Neoplasias Glandulares e Epiteliais
- Doenças Peritoneais
- Neoplasias Genitais Femininas
- Doenças do Sistema Endócrino
- Doenças ovarianas
- Doenças anexiais
- Distúrbios Gonadais
- Neoplasias do Aparelho Digestivo
- Neoplasias das Glândulas Endócrinas
- Neoplasias Abdominais
- Neoplasias ovarianas
- Neoplasias Peritoneais
- Carcinoma Epitelial Ovariano
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Anti-Infecciosos
- Antivirais
- Inibidores Enzimáticos
- Antimetabólitos, Antineoplásicos
- Antimetabólitos
- Agentes Antineoplásicos
- Agentes imunossupressores
- Fatores imunológicos
- Gemcitabina
Outros números de identificação do estudo
- NCI-2009-00052 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- P30CA015083 (Concessão/Contrato do NIH dos EUA)
- N01CM62205 (Concessão/Contrato do NIH dos EUA)
- 6307 (Outro identificador: CTEP)
- CDR0000388036
- NCI-6307
- MAYO-MC0362
- MC0362 (Outro identificador: Mayo Clinic)
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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