Cetoconazol no tratamento de participantes com erupção cutânea contínua induzida por inibidores de EGFR
Ensaio duplo-cego, controlado por placebo para explorar o anti-andrógeno, cetoconazol, para o tratamento de pacientes com uma erupção cutânea induzida por inibidor do fator de crescimento epidérmico (EGFR) em curso
This early phase I trial studies the side effects of ketoconazole and how well it works in treating participants with ongoing EGFR inhibitor-induced rash. Ketoconazole may reduce the symptoms related to EGFR inhibitor therapy and improve EGFR inhibitor-induced rash.
Visão geral do estudo
Status
Condições
Descrição detalhada
PRIMARY OBJECTIVES:
I. To demonstrate that topical ketoconazole, an anti-androgen, palliates EGFR inhibitor-induced rash within a group of racially diverse cancer patients.
II. To explore the role of ribonucleic acid (RNA) sequencing to identify other targets that might be used at a later date for rash palliation.
III. To evaluate toxicities associated with topical ketoconazole.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants apply ketoconazole topically twice daily (BID) on days 1-28.
ARM II: Participants apply placebo topically BID on days 1-28.
After completion of study treatment, participants are followed up at 1 week.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase inicial 1
Contactos e Locais
Locais de estudo
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Illinois
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Danville, Illinois, Estados Unidos, 61832
- Carle on Vermilion
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Urbana, Illinois, Estados Unidos, 61801
- Carle Cancer Center
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic in Rochester
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Saint Louis Park, Minnesota, Estados Unidos, 55426
- Park Nicollet Frauenshuh Cancer Center
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Saint Paul, Minnesota, Estados Unidos, 55101
- Regions Hospital
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New York
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Rochester, New York, Estados Unidos, 14642
- University of Rochester
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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:
- Patient has developed a rash or symptoms of a rash (cutaneous burning) characteristic of an EGFR inhibitor (health-care provider report of the rash with no other documentation is permitted)
- Patient is anticipated to continue for at least 28 days with an EGFR inhibitor or restart =< 14 days of registration and continue for at least 28 days
- Mayo only: Patient is willing to provide a skin biopsy for correlative research; Note: Can be waived with permission of study chair (documentation such as an email must be provided)
- Patient must complete baseline quality of life (QOL) packet
Exclusion Criteria:
- Patient has a prior allergy or intolerance of ketoconazole
- Patient has an allergy or intolerance to sulfites
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Arm I (ketoconazole)
Participants apply ketoconazole topically BID on days 1-28. |
Correlative studies Ancillary studies
Outros nomes:
Ancillary studies Applied topically
Outros nomes:
|
|
Comparador de Placebo: Arm II (placebo)
Participants apply placebo topically BID on days 1-28. |
Correlative studies Ancillary studies
Outros nomes:
Ancillary studies Applied topically |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Proportion of patients who report an improvement in skin rash
Prazo: Up to 4 weeks
|
Assessed by Skindex-16. Will be estimated using the cumulative incidence function with time to improvement defined as the time from randomization to the first of the two consecutive weeks of improved symptom. The cumulative incidence of rash improvement after 4 weeks of treatment will be summarized separately by treatment arm. The difference in rash improvement incidences will be estimated and will be compared using two-sample Z-test. |
Up to 4 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of skin toxicity
Prazo: Up to 4 weeks
|
As measured by the Skindex-16. Responses to the Skindex-16 will be categorized into three subscales: symptom, emotional, and functional. Analysis of the total scales and subscales of the Skindex-16 will involve a t-test and Wilcoxon rank sum procedures (as appropriate) at each time point as well as linear mixed modeling. Descriptive factors will be used as covariates in the modeling analysis. The change from baseline in the total score and subscales of the Skindex-16 will be compared between two arms by a two-sample, two-sided t-test. If there is evidence of non-normality (via Shapiro-Wilk testing), a non-parametric procedure such as Wilcoxon rank sum will be used. |
Up to 4 weeks
|
|
Incidence of skin toxicity
Prazo: Up to 4 weeks
|
As measured by the Skin Toxicity Assessment Tool (STAT). Responses to the STAT will be categorized into three subscales: symptom, emotional, and functional. Analysis of the total scales and subscales of the STAT will involve a t-test and Wilcoxon rank sum procedures (as appropriate) at each time point as well as linear mixed modeling. Descriptive factors will be used as covariates in the modeling analysis. The change from baseline in the total score and subscales of the STAT will be compared between two arms by a two-sample, two-sided t-test. If there is evidence of non-normality (via Shapiro-Wilk testing), a non-parametric procedure such as Wilcoxon rank sum will be used. |
Up to 4 weeks
|
|
Incidence of adverse events for ketoconazole
Prazo: Up to 4 weeks
|
Adverse events will be tabulated by treatment arm. Frequencies of various types of adverse events (AEs) will be compared using Fisher's exact test. Will explore the difference in reliability of the direct versus (vs.) indirect AE attribution approaches in the placebo arm. |
Up to 4 weeks
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in PLA2G4D, PLOD2, and SALL4
Prazo: Baseline up to 4 weeks
|
Assessed by ribonucleic acid (RNA) sequencing. Will explore the association between baseline/change in PLA2G4D, PLOD2, and SALL4 with rash improvement. Baseline gene expression level and change from baseline in gene expression level for the androgen-related genes such as PLA2G4D, PLOD2, and SALL4 will be compared between arms by t-test and Wilcoxon rank sum procedures (as appropriate). Mixed Models for Logistic Regression will also be implemented to explore the association between PLA2G4D, PLOD2, and SALL4 with rash improvement by adjusting the baseline gene expression level and change from baseline in gene expression levels for each gene. Descriptive factors will be used as covariates in the modeling analysis. |
Baseline up to 4 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Aminah Jatoi, M.D., Mayo Clinic
- Investigador principal: Elizabeth J. Cathcart-Rake, M.D., Mayo Clinic
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MC17C1
- MC17C1 (Outro identificador: Mayo Clinic in Rochester)
- NCI-2018-00355 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- R01CA207183 (Concessão/Contrato do NIH dos EUA)
- 17-007786 (Outro identificador: Mayo Clinic Institutional Review Board)
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