Gynecologic Cancer 286B

April 26, 2017

Sponsor: Gynecologic Oncology Group

Number: 286B

Eligible patients who enroll in the study will be randomly assigned (by chance) to this phase II/III trial studies how well Paclitaxel, Carboplatin, and Metformin Hydrochloride works and compares it to Paclitaxel, Carboplatin, and placebo in treating patients with endometrial cancer that is stage III, IV, or has come back. (Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely) . Chemotherapy drugs such as Paclitaxel and Carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Metformin Hydrochloride may help Paclitaxel and Carboplatin work better by making cancer cells more sensitive to the drugs. It is not yet known whether Paclitaxel and Carboplatin are more effective with or without Metformin Hydrochloride in treating endometrial cancer.

Who’s eligible:

• Patients must have measurable stage III (- cancer which has spread from the site of the primary (original) tumor only to surrounding tissue, lymph nodes), measurable stage IVA, stage IVB (or the development of secondary malignant growths at a distance from a primary site of cancer, with or without measurable disease) or recurrent (with or without measurable disease) endometrial carcinoma.
• Histologic confirmation of the original primary tumor is required.
• Patients with the following histologic epithelial cell types are eligible:
  • Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.)
• Measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1-a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same("stabilize"), or worsen ("progress") during treatment. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray. Lymph nodes must be >= 15 mm in short axis when measured by CT or MRI.
• Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2.
• This study is for women 18 or older.

Available at: The Hospital of Central Connecticut, Hartford Hospital.