Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Metformin in Non Small Cell Lung Cancer (NSCLC)

Summary: The goal of this clinical research study is to learn if giving metformin in combination with radiation therapy is more effective than radiation therapy alone. In this study, participants will receive either metformin or a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Detailed description: Study Groups:
  If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to receive either metformin or a placebo. This is done because no one knows if one study group is better, the same, or worse than the other group. For every 7 participants enrolled in this study, 6 will receive metformin and 1 will receive a placebo.
  Only the study staff will know if you are receiving the study drug or the placebo.
  Study Drug/Placebo Administration:
  You will begin taking metformin/placebo 3 weeks before you begin radiation therapy. You will take it each week during radiation therapy. You will take the drug/placebo 3 times a day (in the morning, at noon, and in the evening).
  To decrease the GI side effects you will start metformin at 1000 mg daily in a divided dose (in the morning and in the evening) for 1 week.
  You will keep a log for each time that you take metformin/placebo. You should bring the log with you to each study visit.
  You will also receive Benadryl (diphenhydramine) and prednisone to help prevent side effects.
  There will be no change to your radiation therapy. You will receive a separate consent form that describes the radiation therapy and its risks.
  Study Visits:
  Every week while you are taking the study drug/placebo, blood (about 2-3 teaspoons) will be drawn for routine tests.
  You will have a positron emission tomography-computed tomography (PET-CT) scan before starting metformin/placebo to check the status of the disease.
  Length of Study:
  You may continue taking the study drug/placebo for up to a total of 2 weeks during radiation treatment. You will no longer be able to take the study drug/placebo if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
  Follow-Up:
  Your medical records will be checked for up to 6 months after your radiation therapy.
  This is an investigational study. Metformin is FDA approved for the treatment of diabetes. Its use in this study to be given with radiation therapy to treat lung cancer is investigational. The study doctor can explain how the study drug is designed to work.
  Up to 70 participants will be enrolled in this study. All will take part at MD Anderson.

Eligibility: Inclusion Criteria:
  1. Patients with pathologic diagnosis of lung NSCLC or squamous cell carcinoma.
  2. Patients are to be treated with hypofractionated RT.
  3. Patient is not a surgical candidate due to medical comorbidities determined by a thoracic surgeon or patient refusal
  4. Patient plans to receive treatment at MD Anderson
  5. Patients must sign informed consent
  6. Patient must have adequate renal function within 30 days prior to registration, defined as serum creatinine within normal institutional limits or creatinine clearance at least 60 ml/min
  Exclusion Criteria:
  1. Patient has: random glucose >200 mg/dl or is taking an oral hypoglycemic agent or insulin at the time of study entry
  2. Patient has a history of lactic acidosis, chronic kidney disease or a creatinine >/= 1.2 mg/dl
  3. Women who are pregnant or breast feeding, as treatment involves unforeseeable risks to the participant, embryo, fetus, or nursing infant
  4. Patients with history of allergic reaction to metformin

Relevance to patient case: not relevant