Study on Metformin and Chemotherapy for Treating Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Sponsor: University of Chicago
ClinicalTrials ID:NCT02122185
This clinical trial is exploring whether adding metformin to standard chemotherapy can improve treatment outcomes for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer. The study aims to see if this combination can help stop cancer from growing or coming back.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to find out if combining metformin with standard chemotherapy drugs (carboplatin, paclitaxel, and docetaxel) can better control advanced ovarian, fallopian tube, or primary peritoneal cancer. Metformin is a medication that may make cancer cells more sensitive to chemotherapy, potentially improving treatment effectiveness. Researchers will also study blood and tissue samples to understand how metformin affects cancer cells and patient responses to treatment.
Description
The study is divided into two groups. In the first group, patients will receive metformin along with standard chemotherapy for up to six cycles, followed by continued metformin treatment for up to two years if the cancer does not progress or cause severe side effects. In the second group, patients will receive a placebo instead of metformin, along with the same chemotherapy regimen, and continue with the placebo for up to two years under the same conditions.
The main goal is to see if adding metformin can extend the time patients live without the cancer getting worse compared to chemotherapy alone. Researchers will also compare how well the cancer responds to treatment, the side effects experienced, and overall survival rates between the two groups. Additionally, the study will explore how metformin works at a molecular level in these types of cancer.
Patients will receive chemotherapy every 21 days for up to six cycles. The specific chemotherapy regimen will be determined by the treating physician and may include different combinations of paclitaxel, docetaxel, and carboplatin. After completing the study treatment, patients will be monitored for two years to track their health and any changes in their cancer.
Eligibility Criteria
Inclusion Criteria
- Suspected ovarian cancer with specific symptoms and test results.
- Aged 18 years or older.
- Good overall health with an ECOG performance status of 0 to 2.
- Adequate blood cell counts and organ function based on specific lab tests.
- Not diabetic and not taking diabetes medications.
- Willing to use effective birth control during the study if of childbearing potential.
- Able to understand and sign a consent form.
- For registration, must have confirmed advanced ovarian, fallopian tube, or primary peritoneal cancer.
- Must agree to receive one of the specified chemotherapy regimens for up to eight cycles.
Exclusion Criteria
- Known diabetes or taking diabetes medications.
- Participating in other investigational drug studies.
- Health conditions that limit expected survival to less than two years for reasons other than cancer.
- Active or recently treated invasive cancer with a high chance of recurrence.
- Allergic reactions to metformin or similar drugs.
- Conditions that increase the risk of metformin-related side effects, such as severe heart failure or liver disease.
- Uncontrolled illnesses that could interfere with study participation.
- Pregnant or breastfeeding women.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.