Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer
Status: | Active, not recruiting |
---|---|
Conditions: | Lung Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/18/2018 |
Start Date: | October 2012 |
End Date: | June 2019 |
A Pilot Study of Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer
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.
standard of care for lung cancer or just standard of care.
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.
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.
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
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