Terminé

Everolimus, Letrozole et Metformine pour le carcinome endométrial avancé

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But de l'étude

Cette étude vise à évaluer l'efficacité de la combinaison d'Everolimus, de Letrozole et de Metformine pour apporter des bénéfices cliniques aux patientes atteintes d'un cancer de l'endomètre avancé.

Ce qui est testé

Traitement quotidien au Metformin pour le cancer

+ Comprimé de Letrozole Quotidien

+ Traitement quotidien à l'Évérolimus

Médicament
Qui peut participer

Maladies génito-urinaires+9

+ Maladies Génitales

+ Maladies urogénitales féminines et complications de la grossesse

À partir de 18 ans
+30 critères d'éligibilité
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Phase 2
Interventionnel
Date de début : octobre 2013
Voir le détail du protocole

Résumé

Sponsor principalM.D. Anderson Cancer Center
Dernière mise à jour : 30 juillet 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 7 octobre 2013

Date à laquelle le premier participant a commencé l'étude.

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
Sponsor principalM.D. Anderson Cancer Center
Dernière mise à jour : 30 juillet 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

62 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

À partir de 18 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Maladies génito-urinairesMaladies GénitalesMaladies urogénitales féminines et complications de la grossesseMaladies génitales fémininesNéoplasmes Génitaux FémininsNéoplasmesNéoplasmes par siteNéoplasmes urogénitauxMaladies utérinesNéoplasmes utérinsMaladies urogénitales fémininesNéoplasmes de l'endomètre

Critères

12 critères d'inclusion nécessaires pour participer
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 critères d'exclusion empêchent la participation
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

Voir plus de critères

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

Un seul groupe d'intervention est désigné dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
Les participants commencent par prendre de la Metformine seule pendant 7 à 10 jours. Ensuite, ils ajoutent du Letrozole et de l'Everolimus à leur routine quotidienne. La dose de Metformine augmente à deux fois par jour, tandis que le Letrozole et l'Everolimus sont pris une fois par jour.

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 6 sites

Sacred Heart Health Systems

Pensacola, United StatesOuvrir Sacred Heart Health Systems dans 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
Terminé6 Centres d'Étude