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Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer
||GOG-0286B: A Randomized Phase II/III Study of Paclitacel/Carboplatin/Metformin (NSC # 91485) versus Paclitaxel/Carboplatin/Placebo as Initial Therapy for Measurable Stage III or IVA, Stage IVBm or Recurrent Endometrial Cancer
||Young Kim, MD
The purpose of this study is to find out if the drug combination of paclitaxel, carboplatin and metformin works better than paclitaxel and carboplatin alone in treating endometrial cancer and to find out what side effects are caused by these study drugs. The combination of paclitaxel, carboplatin and metformin for participants with advanced or recurrent endometrial cancer is investigational. In order to better determine if the addition of metformin to paclitaxel and carboplatin helps better treat endometrial cancer, half of the women in this study will receive metformin with paclitaxel and carboplatin and the other half will receive a placebo with paclitaxel and carboplatin. A placebo is a tablet or pill with no active ingredients.
- Participants must have Stage III, IV or recurrent endometrial cancer
- Participants must not have had prior therapy for endometrial cancer, except they may have had prior hormonal therapy
- Participants must have adequate organ function and be able to tolerate chemotherapy and swallow pills
- Participants cannot be taking or have taken Metformin within the last 6 months
- Participants cannot be pregnant or lactating
- Participants cannot have complicating malignancies or illnesses
During the initial visit, participants will have blood drawn and imaging of the chest and tumor to confirm eligibility. Participants will come to the hospital every 3 weeks, on the first day of each cycle during their chemotherapy. At each visit, they will have blood drawn, as is standard for clinical care. Chemotherapy lasts for 6 cycles. After chemotherapy and during the maintence regimen, participants will come for a visit every 3 months. At each visit, they will have blood drawn, as is standard for clinical care. Participants will continue on the maintenance regimen until disease progression. Once off the maintenance regimen, participants will be followed every 3 months for 2 years and then every 6 months for another 3 years. At some point during or after chemotherapy, participants will have 7-10 mL (1.5-2 teaspoons) of blood drawn for research purposes.