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Everolimus, Letrozol y Metformina para Carcinoma Endometrial Avanzado

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Objetivo del estudio

Este estudio tiene como objetivo evaluar la eficacia de la combinación de Everolimus, Letrozol y Metformina en proporcionar beneficios clínicos a pacientes con carcinoma de endometrio avanzado.

Qué se está evaluando

Metformina Diaria para el Tratamiento del Cáncer

+ Comprimido diario de Letrozole

+ Tratamiento diario con Everolimus

Medicamento
Quiénes están siendo reclutados

Enfermedades Urogenitales+7

+ Enfermedades Genitales

+ Enfermedades Urogenitales Femeninas y Complicaciones del Embarazo

A partir de 18 años
+30 Criterios de eligibilidad
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 2
Intervencional
Inicio del estudio: octubre de 2013
Ver detalles del protocolo

Resumen

Patrocinador PrincipalM.D. Anderson Cancer Center
Última actualización: 30 de julio de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 7 de octubre de 2013

Fecha en la que se inscribió al primer participante.

Study Drug Administration: If you are found to be eligible to take part in this study and you are not already taking metformin, you will take metformin before you begin the regular study cycles (Cycles 1 and beyond). This will be called "Cycle 0." You will take metformin by mouth 1 time a day on Days 1-4 of Cycle 0 and then 2 times a day (about 12 hours apart) every day after that. You will take metformin for 7-10 days in Cycle 0 before Cycle 1 begins. If you are already taking metformin, you will continue your regular dose and start Day 1 of Cycle 1. If you are already taking metformin but your dose is less than 1000mg/day, your dose will be slowly raised up to the study dose over the course of 7-10 days and then you will start Cycle 1. In Cycles 1 and beyond, all participants will take all 3 drugs at a time. You should take metformin with food. Starting in Cycle 1, you will take everolimus 1 time a day by mouth at about the same time every day. You should take it either consistently with food every day or consistently without food every day. Starting in Cycle 1, you will take letrozole 1 time a day by mouth at about the same time every day. It is very important for you to take the study drugs just as the study doctor tells you. Do not skip any doses unless your study doctor tells you to skip doses. If you throw up after taking the study drugs, you should NOT take another tablet that day. Let your study doctor know that you got sick. If you forget to take the study drugs one day, do not take any extra doses the next day. Call your study doctor and ask for advice. There are 4 weeks in each cycle (except Cycle 0). Study Visits: Every cycle (+/- 10 days): * You will have a physical exam, including measurement of your vital signs and weight. * Your performance status will be recorded. * You will be asked about any side effects you may have had. * Blood (about 2 tablespoons) will be drawn for routine tests. * If the doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to check for hepatitis. After Cycles 2, 4, and 6 and then every 3 cycles after that (Cycles 9, 12, 15, and so on) (+/- 10 days): * You will have scans such as a CT scan and/or MRI to check the status of the disease. * If you have chest disease, you will have a CT scan of the chest. * If the disease could be felt in the pelvis at the beginning of the study, you will have a pelvic exam After every other cycle (Cycles 2, 4, and so on), blood (about 1 teaspoon) will be drawn for routine tests. Length of Treatment: You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. Your participation on the study will be over after the follow-up visits. End-of-Treatment Visit: Within 4 weeks after the last dose of study drugs: * You will have a physical exam, including a pelvic exam and measurement of your vital signs and weight. * Your performance status will be recorded. * You will be asked about any side effects you may have had. * Blood (about 2 tablespoons) will be drawn for routine tests. * You will have scans such as a CT scan and/or MRI to check the status of the disease. * If you have chest disease, you will have a CT scan of the chest. Follow-Up: You will have follow-up visits as often as the doctor thinks is needed. At every visit: * You will have a physical exam, including measurement of your vital signs. * Your performance status will be recorded. * You will be asked about any side effects you may have had. * If the doctor thinks it is needed, you will have scans such as a CT scan and/or MRI to check the status of the disease. * If you have chest disease, you will have a CT scan of the chest. As often as the doctor thinks is needed, the study staff will call you to ask about side effects you may have had. These calls should last 5-10 minutes. . This is an investigational study. Everolimus is FDA approved and commercially available to treat kidney, breast, and pancreatic cancers. Letrozole is FDA approved and commercially available to treat breast cancer and ovarian cancer. Metformin is FDA approved and commercially available to treat diabetes. The combination of everolimus, metformin, and letrozole in this study to treat endometrial cancer is investigational. Up to 64 patients will be enrolled in this study. Up to 59 may take part at MD Anderson. Up to 5 patients per site may be enrolled at MD Anderson Cooper and Spartanburg Regional Healthcare System and Harris Health System.

NCT01797523
Patrocinador PrincipalM.D. Anderson Cancer Center
Última actualización: 30 de julio de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 62 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Enfermedades UrogenitalesEnfermedades GenitalesEnfermedades Urogenitales Femeninas y Complicaciones del EmbarazoEnfermedades Genitales FemeninasNeoplasias Genitales FemeninasNeoplasiasNeoplasias por SitioNeoplasias UrogenitalesEnfermedades del ÚteroNeoplasias uterinas

Criterios

12 criterios de inclusión requeridos para participar
Adequate bone marrow function as shown by: ANC >= 1.5 x 10^9/L, Platelets >= 100 x 10^9/L, Hb > 9 g/dL

Adequate liver function as shown by: a. serum bilirubin <= 1.5 x ULN b. ALT and AST <= 2.5x ULN ( <= 5x ULN in patients with liver metastases); Adequate renal function:serum creatinine < 1.4mg/dL (per manufacturer, metformin is contraindicated in the presence of renal dysfunction defined as a serum creatinine > 1.4 mg/dL in females and in patients with abnormal clearance) ; Fasting serum cholesterol <= 240 mg/dL OR <= 7.75 mmol/L AND fasting triglycerides <= 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication

Age >= 18 years

All patients must have measurable disease per RECIST 1.1 defined as at least one target lesion that can be accurately measured in at least one dimension ( >= 10mm longest dimension to be recorded; Lymph nodes must be >= 15 mm per short axis). Each lesion must be > 20 mm when measured by palpation or conventional imaging techniques (CT or MRI - based on primary physician preference) or > 10 mm with spiral CT scan. Measurable lesions must be at least 2 times the slice thickness in millimeters. Tumors within a previously irradiated field will be designated as non-target lesions unless progression is documented. Ascites and pleural effusions are not considered measurable disease. If the measurable disease is confined to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology

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18 criterios de exclusión impiden participar
CONTINUED FROM 10 - e. Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C). Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection; f. A known history of HIV seropositivity; g. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection); h. Patients with an active, bleeding diathesis

Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. Adequate contraception must be used throughout the trial and for 8 weeks after the last dose of study drug, by both sexes. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of everolimus)

History of noncompliance to medical regimens

Other malignancies within the past 3 years except for basal or squamous cell carcinomas of the skin

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Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

Un solo grupo de intervención está designado en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Los participantes comienzan con Metformina sola durante 7-10 días. Luego, añaden Letrozol y Everolimus a su rutina diaria. La dosis de Metformina aumenta a dos veces al día, mientras que el Letrozol y el Everolimus se toman una vez al día.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene 6 ubicaciones

Sacred Heart Health Systems

Pensacola, United StatesAbrir Sacred Heart Health Systems en Google Maps

MD Anderson Cooper Cancer Center

Voorhees Township, United States

Memorial City Medical Center

Houston, United States

Lyndon B Johnson General Hospital

Houston, United States
Completado6 Centros de Estudio