Clinical Trial TitleMetformin hydrochloride and combination chemotherapy in treating patients with stage III-IV ovarian, fallopian tube, or primary peritoneal cancer.
Clinical Trial Protocol Description:
Ovarian cancer accounts for more deaths than any other cancer of the female reproductive system. The standard treatment of ovarian, fallopian tube, or primary peritoneal is surgery followed by 6 cycles of a platinum and taxane containing chemotherapy regimen and close follow-up of the patient. The cancer may initially respond to this treatment, but 80% of women with advanced disease will have a recurrence of the disease.
Metformin is a medication used to treat diabetes that is widely used as first line therapy for type II diabetes. Recent evidence suggests that metformin may also kill cancer cells and be helpful in both the treatment and prevention of many cancers, including ovarian, fallopian tube and/or primary peritoneal cancer. Metformin is FDA approved, but not for cancer treatment and is being used as an investigational agent in this study.
This is a randomized placebo controlled phase II trial of metformin and chemotherapy followed by metformin maintenance therapy in patients with advanced stage ovarian, fallopian tube and/or primary peritoneal cancer. A placebo-controlled trial is a clinical study in which a control group of patients receive a placebo (a pill with no drug). A randomized study is a study in which the participants are assigned by chance (like a flip of the coin) to separate groups that compare different treatments; neither the study doctors nor the participants can choose which group they are assigned to. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively.
Treatment is expected to be administered on an outpatient basis. In the absence of treatment delays due to adverse event(s), treatment with metformin or placebo as a single agent will continue to complete a total duration of 2 calendar years from the date of randomization (approximately 28 cycles of single agent metformin/placebo where a cycle is counted as three weeks of daily therapy) or until there is disease progression.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have a reasonable suspicion of ovarian cancer by the treating oncologist.
- Are a woman 18 years of age or older.
- Hhave normal organ and bone marrow function.
You will be excluded from the study if any of the following criteria apply to you:
- Have known diabetes and are taking metformin, sulfonylureas, thiazolidenediones or insulin for any reason.
- Are receiving any other investigational agent.
- Have conditions that would limit their two year survival for reasons other than ovarian cancer.
This is a partial list of inclusion and exclusion criteria.