Metformin + Chemotherapy for Ovarian Cancer

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

110 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Seiko Yamada

Principal Investigator

University of Chicago

Eligibility Criteria

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

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

Leukocytes >= 3,000/mcL

Absolute neutrophil count >= 1,500/mcL

Timeline

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

Treatment Details

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.

Participant Groups

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+