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

Completed · Phase 2 · Has a placebo group

Conditions studied: Brenner Tumor, Malignant Ascites, Malignant Pleural Effusion, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mixed Epithelial Carcinoma, Ovarian Serous Cystadenocarcinoma, Ovarian Undifferentiated Adenocarcinoma, Recurrent Fallopian Tube Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Ovarian Germ Cell Tumor, Recurrent Primary Peritoneal Cavity Cancer, Stage IIIA Fallopian Tube Cancer, Stage IIIA Ovarian Epithelial Cancer, Stage IIIA Ovarian Germ Cell Tumor, Stage IIIA Primary Peritoneal Cavity Cancer, Stage IIIB Fallopian Tube Cancer, Stage IIIB Ovarian Epithelial Cancer, Stage IIIB Ovarian Germ Cell Tumor, Stage IIIB Primary Peritoneal Cavity Cancer, Stage IIIC Fallopian Tube Cancer, Stage IIIC Ovarian Epithelial Cancer, Stage IIIC Ovarian Germ Cell Tumor, Stage IIIC Primary Peritoneal Cavity Cancer, Stage IV Fallopian Tube Cancer, Stage IV Ovarian Epithelial Cancer, Stage IV Ovarian Germ Cell Tumor, Stage IV Primary Peritoneal Cavity Cancer

In brief

This randomized phase II trial studies how well metformin hydrochloride and combination chemotherapy works in treating patients with stage III-IV ovarian, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Metformin hydrochloride may help carboplatin, paclitaxel and docetaxel work better by making tumor cells more sensitive to the drugs. Studying samples of blood and tissue in the laboratory from patients receiving metformin hydrochloride may help doctors learn more about the effects of metformin hydrochloride on cells. It may also help doctors understand how well patients respond to treatment. Giving metformin hydrochloride together with combination chemotherapy may kill more tumor cells.

Key facts

Study ID: NCT02122185
Run by: University of Chicago
People needed: 111
Starts: 2015-02-25
Expected to finish: 2024-10-08
Last updated by the study team: 2026-03-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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 =< 250 with no evidence of gastrointestinal (GI) cancer
Aged 18 years or older
Eastern Cooperative Oncology Group (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)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.0 × institutional upper limit of normal
Creatinine =< institutional upper limit of normal (ULN) OR creatinine clearance >= 60 mL/min/1.73 m\^2
Blood glucose =< 126 mg/dL fasting or =< 140 mg/dL nonfasting
Signed written pre-registration informed consent document
ELIGIBILITY CRITERIA FOR REGISTRATION:
Histologically confirmed carcinoma consistent with ovarian, fallopian tube, or primary peritoneal carcinoma
Subjects undergoing primary debulking surgery must have stage III or IV disease and have undergone surgery to include, at a minimum, removal of the uterus, ovaries and fallopian tubes; these patients may be optimally debulked (less than 1 cm residual disease) but must have grossly visible macroscopic residual disease OR be suboptimally debulked
Subjects for whom neoadjuvant chemotherapy followed by interval cytoreductive surgery is planned must have fine needle aspirate (FNA) or other cytology showing adenocarcinoma OR core biopsies OR surgically directed biopsies showing adenocarcinoma AND CA125 over 250 OR CA125:CEA ratio > 25 OR CA =< 250 with no evidence of GI cancer; they should have presumed stage III or IV disease, generally based on abdominal carcinomatosis, omental caking, pleural effusions or ascites
Subject and her physician must agree to six cycles or up to 8 cycles of one of the standard of care regimens allowed on this protocol; these regimens (starting dosage) include:
If < 70 years old:
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
If 70 years or older:
IV paclitaxel 135 mg/m\^2 plus IV carboplatin AUC 5 plus optional G-CSF every 21 days
IV paclitaxel 60 mg/m\^2 day 1, 8, 15 plus IV carboplatin AUC 5 every 21 days (Day 15 paclitaxel optional)
IV paclitaxel 60 mg/m\^2 plus IV carboplatin AUC 2 day 1, 8, and 15 every 21 days

You may not qualify if…

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 psychiatric illness/social situations that would limit compliance with study requirements
pregnant or nursing women

Where it is running

University of Alabama — Birmingham, Alabama, United States
Mitchell Cancer Institute - University of South Alabama — Mobile, Alabama, United States
City of Hope — Duarte, California, United States
NCH Medical Group- Northwest Community Hospital — Arlington Heights, Illinois, United States
Rush University Medical Center — Chicago, Illinois, United States
University of Chicago — Chicago, Illinois, United States
Decatur Memorial Hospital — Decatur, Illinois, United States
NorthShore University HealthSystem — Evanston, Illinois, United States
Ingalls Memorial Hospital — Harvey, Illinois, United States
Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.