A Phase II/III Study of Paclitaxel/Carboplatin with and without Metformin for Treating Stage III or IV or Recurrent Endometrial Cancer

Protocol
14-081
Full Title
A Randomized Phase II/III Study of Paclitaxel/Carboplatin/Metformin (NSC#91485) Versus Paclitaxel/Carboplatin/Placebo as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer (GOG-0286B)
Phase
II/III
Purpose

Paclitaxel and carboplatin are standard chemotherapy drugs used to treat endometrial cancer. One way to make treatment more effective is to add new drugs to standard therapy. In this Gynecologic Oncology Group study, researchers want to see if adding the drug metformin to paclitaxel and carboplatin is more effective against advanced and recurrent endometrial cancer than paclitaxel/carboplatin alone.

Metformin is a drug commonly used to treat diabetes, but its use in this study is considered investigational. Other studies have suggested that metformin may be useful for preventing or treating certain cancers. It is a pill that is taken orally (by mouth). Paclitaxel and carboplatin are given intravenously (by vein).

Women in this study will be randomly assigned to receive either paclitaxel, carboplatin, and metformin OR paclitaxel, carboplatin, and placebo.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage III or IV or recurrent endometrial cancer that has not yet been treated with chemotherapy.
  • Patients may have received prior pelvic radiation therapy or hormonal therapy for endometrial cancer; at least 4 weeks must have passed since completion of radiation therapy and 1 week since completion of hormonal therapy and entry into the study.
  • Patients may not have previously taken metformin within 6 months of entering the study.
  • This study is for women age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Carol Aghajanian at 646-888-4217.

Disease(s)
Uterine (Endometrial) Cancer

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