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Uterine Clinical Trials

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GOG 0286B

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

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Lauren Downing, BS

    484-526-7936

    Lauren.downing@sluhn.org
  • Treatment Agent: Metformin

    Synopsis: 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 your type of cancer and to find out what side effects are caused by treatment with these drugs. The combination of paclitaxel, carboplatin and metformin in the treatment of 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.

    • Patients must have measurable stage III, measurable stage IVA, stage IVB (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); 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
    • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
    • Platelets greater than or equal to 100,000/mcl
    • Creatinine less than 1.4 mg/dl
    • Bilirubin less than or equal to 1.5 x institutional/laboratory upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 x ULN
    • Alkaline phosphatase less than or equal to 2.5 x ULN
    • Patients must NOT have received prior chemotherapy or targeted therapy, including chemotherapy used for radiation sensitization for treatment of endometrial carcinoma
    • Patients may have received prior radiation therapy for treatment of endometrial carcinoma; prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy, and/or intravaginal brachytherapy; all radiation therapy must be completed at least 4 weeks prior to the first date of study therapy
    • Patients may have received prior hormonal therapy for treatment of endometrial carcinoma; all hormonal therapy must be discontinued at least one week prior to the first date of study therapy
    • Patients must be able to swallow and retain orally-administered medication
    • Patients must have signed an approved informed consent and authorization permitting release of personal health information; individuals with impaired decision-making capacity are not eligible to participate on the study
    • Patients must NOT be taking metformin or have been on metformin in the past 6 months
    • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the last three years
    • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
    • Patients who are pregnant or nursing; if patients are of reproductive age and have not undergone hysterectomy, they must use an effective contraceptive method for the duration of this study
    • Any condition associated with increased risk of metformin-associated lactic acidosis; (e.g. congestive heart failure defined as New York Heart Association [NYHA] class III or IV functional status, history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day)