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Metformin + Chemotherapy for Ovarian Cancer

Phase 2

Waitlist Available

Led By Seiko Yamada

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18 years or older

Eastern Cooperative Oncology Group (ECOG) performance status =< 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Summary

This trial is testing how well a combination of metformin hydrochloride and chemotherapy drugs work in treating patients with advanced ovarian, fallopian tube, or peritoneal cancer. The chemotherapy drugs

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Chemotherapy may cause side effects such as nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts. Metformin's side effects include digestive issues like diarrhea or stomach pain. Each person's experience with side effects can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

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My kidney function is within normal range or better.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression free survival (PFS) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 and Gynecological Cancer Intergroup (GCIG) criteria

Secondary study objectives

Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Overall survival

Time to biochemical (CA-125) progression using GCIG criteria

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Metformin plus chemotherapyExperimental Treatment2 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 chemotherapyPlacebo Group2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

metformin hydrochloride

2010

Completed Phase 3

~5940

Chemotherapy

2003

Completed Phase 4

~3050