Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer
Conditions
Lung Neoplasms - Carcinoma, Non-Small-Cell Lung
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
Bronchoscopy, Metformin
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Intervention
Name: Metformin Type: Drug
Name: Placebo Comparator Type: Other
Overall Status
Recruiting
Summary
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.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Status: Recruiting
Start Date
October 2012
Completion Date
January 2019
Sponsors
Mayo Clinic
Source
Mayo Clinic
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page