Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer
Basic Trial Information
|Phase II||Prevention||Active||Over 18||Other||12-006865|
The purpose of this study is to learn whether it is better to receive the drug Metformin with standard of care for lung cancer or just standard of care.
Further Study Information
Participants will need to be scheduled to undergo a surgical resection of their lung cancer at the Mayo Clinic in Rochester, MN. They will be asked to provide a blood sample prior to their surgery. Samples of tumor tissue and normal lung tissue will be taken from the samples removed during your lung surgery. The tissue will be used to evaluate DNA. A skin biopsy at the edge of the incision that has already been made will be done during your surgery. We will take the skin and grow skin fibroblasts. Then we will reprogram the skin fibroblasts into induced pluripotent cells. You will be "randomized" into one of the study groups to either take Metformin for 6 months with your standard of care follow up or to receive standard of care follow up.
- Suspected or biopsy proven Stage IA-IIIA lung squamous cell carcinoma (must be proven SCC at the time of surgery)
- Medically fit for surgical resection (based on surgeon assessment)
- Current or prior smoker
- Age > 18 years old
- Both Male and Female
- Willing and able to consent to study, undergo study interventions, and take study drug
- ECOG performance status 0, 1, 2
- Subject must start Metformin within 90 days of surgery.
- Currently taking metformin or other diabetic drugs
- Current or previous congestive heart failure, renal failure or liver failure
- Creatinine in Women of 1.4 or greater and Creatinine in Men of 1.5 or greater
- Existing untreated or prior cancer <5 years from diagnosis
- Received neo-adjuvant platinum-based chemotherapy or targeted therapy
- Receiving adjuvant platinum-based chemotherapy or targeted therapy after surgical resection
Trial Contact Information
Trial Lead Organizations/Sponsors
Mayo Clinic Cancer Center
- Alliance for Clinical Trials in Oncology
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01717482
ClinicalTrials.gov processed this data on April 09, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.