Clinical Trials

Title   University of Chicago
Principal Investigator/ Physician   Rodney Rocconi, MD
Protocol┬áNo.   UC IRB 13-1235
Open Date   10/03/2017
Gender   Female
Cancer Site   Ovary, Peritoneum, Fallopian Tube
Status   Open
Sponsor   University of Chicago
Contact Email   MCI Clinical Trials
Summary  

Protocol Title: A Randomized Placebo Controlled Phase II Trial of Metformin in Conjunction With Chemotherapy Followed by Metformin Maintenance Therapy in Advanced Stage Ovarian, Fallopian Tube and Primary Peritoneal Cancer

 

Inclusion Criteria:  The subject and her physician must agree to six cycles of one of the standard of care regimens allowed on this protocol; these regimens (starting dosage) include: IV paclitaxel 175 mg/m^2 and carboplatin area under the curve (AUC) 5-6 every 21 days; IV docetaxel 75 mg/m^2 and carboplatin AUC 5-6 every 21 days; IV paclitaxel 80 mg/m^2 day 1, 8, and 15 and carboplatin AUC 5-6 day 1 every 21 days; ECOG performance status =< 2; Leukocytes >= 3,000/mcL; absolute neutrophil count >= 1,500/mcL;  platelets >= 100,000/mcL;  total bilirubin =< upper normal institutional limits (except for patients with Gilbert's disease who are eligible despite elevated serum bilirubin level); AST(SGOT)/ALT(SGPT) =< 2.0 × institutional upper limit of normal; creatinine =< OR institutional ULN OR creatinine clearance >= 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: 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 psychiatric illness/social situations that would limit compliance with study requirements;  pregnant or nursing women are excluded from this stud

 

Clinical Trials.Gov Link:  https://clinicaltrials.gov/ct2/show/NCT02122185?term=UC+IRB13-1235&rank=1

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