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Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Recurrent Advanced Ovarian Epithelial or Peritoneal Cavity Cancer

2 de maio de 2014 atualizado por: National Cancer Institute (NCI)

A Phase II Trial Of Gemcitabine in Combination With 17-Allylaminogeldamycin (17-AAG) In Advanced Epithelial Ovarian And Primary Peritoneal Carcinoma

Phase II trial to study the effectiveness of gemcitabine hydrochloride and tanespimycin in treating patients who have recurrent advanced ovarian epithelial or primary peritoneal cavity cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and tanespimycin, work in different ways to stop tumor cells from dividing so they stop growing or die.

Visão geral do estudo

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

Intervencional

Inscrição (Real)

29

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Minnesota
      • Rochester, Minnesota, Estados Unidos, 55905
        • Mayo Clinic

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

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

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

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 (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.
Dado IV
Outros nomes:
  • Gemzar
  • gemcitabina
  • dFdC
  • cloridrato de difluorodesoxicitidina
Dado IV
Outros nomes:
  • 17-AAG

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
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).

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).

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.
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
Participants were evaluated every 6 weeks on treatment (maximum 42 weeks), and followed up to 5 years from registration.
Overall Survival
Prazo: Every 3 months until disease progression and then every 6 months for up to 5 years.
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.
Every 3 months until disease progression and then every 6 months for up to 5 years.
Toxicity
Prazo: Participants were evaluated every 6 weeks on treatment (maximum 42 weeks)
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.
Participants were evaluated every 6 weeks on treatment (maximum 42 weeks)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Paul Haluska, Mayo Clinic

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de outubro de 2007

Conclusão Primária (Real)

1 de abril de 2010

Conclusão do estudo (Real)

1 de março de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

6 de outubro de 2004

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de outubro de 2004

Primeira postagem (Estimativa)

8 de outubro de 2004

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

20 de maio de 2014

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de maio de 2014

Última verificação

1 de outubro de 2011

Mais Informações

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 .

Ensaios clínicos em Câncer Epitelial de Ovário Estágio IV

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