Metformin as Chemo-sensitizer in Ovarian Malignancies: Can Drug Repositioning in Neo-adjuvant Settings Lead to Better Pathological Response Rates- A Randomized Controlled Trial

Indian Council of Medical Research0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

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•1)Histologically confirmed carcinoma consistent with ovarian, fallopian tube, or primary peritoneal carcinoma
•2)Patients to undergo fine needle aspirate (FNA) or other cytology showing adenocarcinoma OR core biopsies OR surgically directed biopsies showing adenocarcinoma
•3)AND raised CA125 OR CA125 to CEA ratio more than 25 OR CA125 less than equal to 250 with no evidence of GI cancer;
•4)They should have presumed stage III or IV disease, generally based on abdominal carcinomatosis, omental caking, pleural effusions or ascites

•1)Patients who are receiving any other investigational agents.
•2)Patients with comorbidities that would limit their survival.
•3)Patients with known diabetes and already on metformin, sulfonylureas, thiazolidinediones or insulin for any reason.
•4)Concurrent active malignancy or one previously diagnosed.
•5)History of allergic reactions to similar drugs as used in the trial. New York Heart Association class III or IV congestive heart failure, history of acidosis of any type, alcoholic liver disease, or habitual intake of 3 or more alcoholic beverages per day- as these conditions are associated with increased risk of metformin-associated lactic acidosis.
•6)Uncontrolled intercurrent illness like- active major infection, or psychiatric illness/social situations, or unstable angina pectoris, that would limit compliance with study requirements.
•7)Pregnant or nursing women.
•8)Borderline tumors.
•9)Patients who will undergo intraperitoneal chemotherapy.
•10)Patients receiving chemotherapy regimens not specified in the inclusion criteria

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