Diabetes drug metformin may boost chemo for ovarian cancer
NCT ID NCT02122185
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tested whether adding metformin, a common diabetes drug, to standard chemotherapy could help control advanced ovarian, fallopian tube, or primary peritoneal cancer. 111 participants received either metformin or a placebo alongside chemotherapy, followed by maintenance therapy. The goal was to see if metformin could delay cancer progression by making tumor cells more sensitive to chemo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- metformin hydrochloride (Glucophage)
- What this could lead to
- If successful, this could point toward a way to make chemotherapy more effective for advanced ovarian cancer, potentially delaying disease progression.
- What could go wrong
- This is a phase II trial with only 111 participants, so results are preliminary. Metformin may not improve outcomes, and side effects from chemotherapy remain a risk.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
111 people
The number who actually took part.
- Started
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Feb 2015
- Finished
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Oct 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 =\< 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 * 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: 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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City of Hope
Duarte, California, 91010, United States
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Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
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Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Mitchell Cancer Institute - University of South Alabama
Mobile, Alabama, 36604, United States
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NCH Medical Group- Northwest Community Hospital
Arlington Heights, Illinois, 60005, United States
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NorthShore University HealthSystem
Evanston, Illinois, 60201, United States
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Rush University Medical Center
Chicago, Illinois, 60612, United States
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University of Alabama
Birmingham, Alabama, 35233, United States
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University of Chicago
Chicago, Illinois, 60637, United States
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