DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Metformin in Non Small Cell Lung Cancer (NSCLC)

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lung Cancer

Intervention: Metformin (Drug); Placebo (Other); Stereotactic body Radiotherapy (SBRT) (Radiation)

Phase: Phase 2

Status: Recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Heath Skinner, MD, PHD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

Overall contact:
Heath Skinner, MD, PHD, Phone: 713-563-2300

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.

Clinical Details

Official title: Tumor Mutation Status Will Predict Metabolic Response to Metformin in Non Small Cell Lung Cancer (NSCLC)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Tumor Response Between Metformin and Placebo Cohorts

Secondary outcome: Genotype Comparisons of Kras, STK11, and TP53 Mutations

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 3 weeks after 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 SBRT. 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Patients with pathologic diagnosis of lung NSCLC or squamous cell carcinoma. 2. Patients are to be treated with SBRT. 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

Locations and Contacts

Heath Skinner, MD, PHD, Phone: 713-563-2300

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Additional Information

University of Texas MD Anderson Cancer Center Website

Starting date: February 2015
Last updated: August 6, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017