Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Inclusion Criteria

ELIGIBILITY CRITERIA FOR PRE-REGISTRATION

• A reasonable suspicion of ovarian cancer by the treating oncologist is required, evidenced by abdominal carcinomatosis, omental caking, pleural effusions or ascites AND an elevated CA125 > 250 OR CA125:carcinoembryonic antigen (CEA) ratio > 25 OR CA125 = = 3,000/mcL
• Absolute neutrophil count >= 1,500/mcL
• Platelets >= 100,000/mcL
• Total bilirubin = = 60 mL/min/1.73 m^2
• Blood glucose = 25 OR CA = = 3,000/mcL
• absolute neutrophil count >= 1,500/mcL
• platelets >= 100,000/mcL
• total bilirubin = = 60 mL/min/1.73 m^2
• blood glucose =< 126 mg/dL fasting or =< 140 mg/dL nonfasting
• women of child-bearing potential must agree to use an effective method of birth control on trial, as the safety of metformin in pregnancy has not been established; an effective method of birth control includes surgical sterilization of woman or her partner, abstinence, or two barrier methods (e.g. condom plus diaphragm); hormonal methods of birth control are not permitted on this study
• ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

EXCLUSION CRITERIA FOR PRE-REGISTRATION

• Subjects with known diabetes and those taking metformin, sulfonylureas, thiazolidinediones or insulin for any reason
• Patients who are receiving any other investigational agents
• Subjects with comorbidities that would limit their two year survival for reasons other than ovarian cancer
• Concurrent active invasive malignancy or one previously diagnosed with a greater than 30% chance of recurrence in the next two years
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin
• Subjects must not have conditions associated with increased risk of metformin-associated lactic acidosis, including 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
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active major infection, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant or nursing women

EXCLUSION CRITERIA FOR REGISTRATION:

• mucinous adenocarcinoma, borderline tumors
• subjects who will undergo intraperitoneal chemotherapy
• subjects receiving neoadjuvant chemotherapy for whom interval debulking surgery (assuming adequate response to therapy) is not planned
• subjects receiving chemotherapy regimens not specified in the inclusion criteria
• subjects should not be participating in other clinical trials of interventions designed to reduce risk of ovarian cancer recurrence or plan to receive off -protocol maintenance therapy (e.g. paclitaxel or bevacizumab)
• subjects with known diabetes, fasting glucose over 126 mg/dL or random glucose over 140 mg/dL and those taking metformin, sulfonylureas, thiazolidenediones or insulin for any reason
• patients who are receiving any other investigational agents
• subjects with comorbidities which would lead to a clinical expectation that they will not survive two years for reasons other than ovarian cancer
• concurrent active invasive malignancy or one previously diagnosed with a greater than 30% chance of recurrence in the next two years
• history of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin
• subjects must not have conditions associated with increased risk of metformin-associated lactic acidosis, including 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
• uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or