Trial Search Results

Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer

This randomized 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. Drugs used in chemotherapy, 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 is more effective with or without metformin hydrochloride in treating endometrial cancer.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Gynecologic Oncology Group

Collaborator: National Cancer Institute (NCI)


  • Drug: Carboplatin
  • Other: Laboratory Biomarker Analysis
  • Drug: Metformin Hydrochloride
  • Drug: Paclitaxel
  • Other: Placebo
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration


Phase 2/Phase 3


Inclusion Criteria:

   - 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

   - 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

Exclusion Criteria:

   - 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)

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting