Evaluation of Metformin, Targeting Cancer Stem Cells for Prevention of Relapse in Gynecologic Patients
Condition: Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
MeSH terms: Peritoneal Neoplasms
Intervention: Metformin
Intervention description: Patients receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.
Patients treated with neoadjuvant chemotherapy will be initiated on metformin prior to the initiation of chemotherapy. Following surgery patients will be initiated on metformin prior to the re-initiation of chemotherapy.
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: Female
Minimum age: 19 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Summary:

      The primary objective of this study is to determine if metformin administered in combination
      with chemotherapy to women with advanced ovarian, primary peritoneal or fallopian tube cancer
      will improve recurrence-free survival at 18 months compared to controls.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with potential diagnosis of ovarian, fallopian, or primary peritoneal cancer.

          2. Care plan including surgical debulking and traditional adjuvant or neo-adjuvant
             chemotherapy (6-9 cycles of platinum and taxane based therapy).

          3. Eastern Cooperative Oncology Group performance status 0-2.

          4. Age > 18 years or < 80 years.

          5. Adequate renal function (serum creatinine <1.4mg/dL).

          6. Adequate liver function (bilirubin < 1.5 times ULN).

               -  Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) < 5 times the
                  upper limit of normal in case of liver metastases.

               -  ALT or AST < 2.5 times the ULN in absence of liver metastases.

          7. Ability to understand and complete written informed consent.

          8. Mentally, physically, and geographically able to undergo treatment and follow up.

        Exclusion Criteria:

          1. Patients diabetes mellitus. (Patients with only a history of gestational diabetes will
             be allowed to be included in the study.)

          2. Metformin use in the last 6 months.

          3. A known hypersensitivity to metformin.

          4. A history of metabolic acidosis, including ketoacidosis or increased risk of lactic
             acidosis.

          5. Pregnancy or Lactation.

          6. Patients who have any severe and/or uncontrolled medical conditions.

          7. Patients with a history of renal disease.

          8. Patients with other known active malignancy (excluding adequately treated basal cell /
             squamous cell skin cancer, in situ cancer, or other cancer for which the patient has
             been disease free for 2 years).

          9. Patients receiving any other investigational agents.