Metformin + Chemotherapy for Ovarian Cancer

Not currently recruiting at 9 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Chicago

Must not be taking: Metformin, Sulfonylureas, Insulin, others

Disqualifiers: Diabetes, Active malignancy, Heart failure, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 21

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding metformin, a diabetes medication, to standard chemotherapy can improve treatment for advanced ovarian, fallopian tube, or primary peritoneal cancer. Chemotherapy drugs like carboplatin and paclitaxel kill or stop the growth of cancer cells, and metformin might enhance their effectiveness. The trial includes two groups: one receiving metformin with chemotherapy and the other receiving a placebo with chemotherapy. Patients with stage III or IV ovarian cancer who have noticeable tumor growth after surgery might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important advancements in cancer therapy.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking metformin, sulfonylureas, thiazolidinediones, or insulin. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that metformin is generally safe for people. Studies have found that metformin can be used safely at levels that help fight cancer in lab settings, stopping cancer cells from growing in both lab tests and living organisms without causing harm.

The FDA has already approved metformin for treating diabetes, so its safety is well-known. Many people have used it safely for years. Some studies also suggest that people with ovarian cancer who take metformin experience better outcomes.

Chemotherapy drugs like carboplatin, paclitaxel, and docetaxel are also part of the treatment. These drugs have been used for a long time to treat cancer, and doctors are very familiar with their side effects. While side effects can occur, doctors closely monitor patients to manage any issues.

In summary, both metformin and the chemotherapy drugs have well-understood safety profiles. Patients considering joining the trial can feel reassured that these treatments have been extensively studied in other settings. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining metformin with chemotherapy for ovarian cancer because metformin is traditionally used to treat diabetes, but it may also have cancer-fighting properties. Unlike standard ovarian cancer treatments that rely solely on chemotherapy, metformin may enhance the effectiveness of chemotherapy by targeting cancer cell metabolism. This combination could potentially slow down cancer progression more effectively than chemotherapy alone, offering a new avenue for treatment.

What evidence suggests that metformin plus chemotherapy could be an effective treatment for ovarian cancer?

This trial will compare the effects of combining metformin with chemotherapy versus chemotherapy with a placebo for ovarian cancer patients. Research has shown that combining metformin with chemotherapy might benefit ovarian cancer patients. Studies have found that people taking metformin often experience better outcomes, such as longer survival or slower disease progression. Metformin enhances the responsiveness of cancer cells to chemotherapy, improving treatment efficacy. Additionally, it can inhibit the growth of new blood vessels that tumors need to grow and spread. Some evidence even suggests that metformin may reduce the risk of developing ovarian cancer. Overall, these findings indicate that metformin could be a promising addition to standard cancer treatments. ^{1 3 4 5 6}

Who Is on the Research Team?

Seiko Yamada

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for adults with advanced ovarian, fallopian tube, or primary peritoneal cancer. Participants must have a suspicion of ovarian cancer based on certain symptoms and test results, an ECOG performance status of 0-2 (which means they can care for themselves), and adequate organ function as shown by specific blood tests.

Inclusion Criteria

Leukocytes >= 3,000/mcL

I can take care of myself and am up and about more than half of the day.

Absolute neutrophil count >= 1,500/mcL

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Patients receive a standard chemotherapy regimen, including paclitaxel and carboplatin or docetaxel and carboplatin, for 6-8 cycles

18-24 weeks

Every 21 days for up to 6 courses

Metformin Maintenance

Patients receive metformin hydrochloride or placebo orally twice daily for up to 2 years in the absence of disease progression or unacceptable toxicity

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Chemotherapy
• Metformin Hydrochloride

Trial Overview The study is testing if metformin hydrochloride improves the effectiveness of standard chemotherapy drugs like carboplatin, paclitaxel, and docetaxel in treating patients. The trial randomly assigns participants to receive either metformin or a placebo alongside their chemotherapy regimen.

How Is the Trial Designed?

Group I: Metformin plus chemotherapy Experimental Treatment 2 Interventions

Patients receive metformin hydrochloride PO BID and standard chemotherapy for 6 -8 cycles. Treatment with metformin hydrochloride continues for up to 2 years in the absence of disease progression or unacceptable toxicity.

Group II: Placebo plus chemotherapy Placebo Group 2 Interventions

Patients receive placebo PO BID and standard chemotherapy for 6 -8 cycles. Treatment with placebo continues for up to 2 years in the absence of disease progression or unacceptable toxicity.

Chemotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in United States as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Canada as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Japan as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in China as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Switzerland as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7812201/

Metformin and ovarian cancer: the evidence - PMC Prognosis. A few studies have shown a better prognosis of ovarian cancer in metformin users (57-59). In one study, favorable results were limited only to ...

2. atm.amegroups.org atm.amegroups.org/article/view/42993/html

Metformin and ovarian cancer: the evidence - Urpilainen Preclinically metformin has clear chemosensitizing effects in ovarian cancer and it is an effective negative regulator of angiogenesis.

3. aging-us.com aging-us.com/article/102787/text

Metformin: current clinical applications in nondiabetic ... Although a meta-analysis demonstrated that metformin was significantly associated with a lower incidence of ovarian cancer in patients with ...

4. translational-medicine.biomedcentral.com translational-medicine.biomedcentral.com/articles/10.1186/s12967-023-04263-8

Metformin and cancer hallmarks: shedding new lights on ... Epidemiological evidence reveals that metformin reduces the risk of cancer and decreases cancer-related mortality in patients with diabetes; ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3084625/

Metformin Suppresses Ovarian Cancer Growth and ... Our data show for the first time that, in addition to inhibiting tumor cell proliferation, metformin treatment inhibits both angiogenesis and metastatic spread ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4200668/

Metformin in cancer prevention and therapy - PMC The results of preclinical studies undoubtedly confirm the efficacy of metformin to inhibit cancer cell growth in vitro and to reduce tumor spread in animal ...