Clinical trial NCT01717482: Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer
Official title: A Pilot Study of Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Keywords: Bronchoscopy
Metformin
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Alliance for Clinical Trials in Oncology
First posted: 2012-10-30
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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, Minnesota. 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.

Eligibility criteria: Inclusion Criteria

* Suspected or biopsy proven Stage IA-IIIA lung squamous cell carcinoma (SCC) (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
* Eastern Cooperative Oncology Group (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

Primary outcomes:
measure: Evaluate Feasibility of Patient Randomization, Accrual, and Tissue Collection for Study Conduction
timeFrame: 2 years
measure: Number of Participants With 2-year Recurrence Free Survival
timeFrame: 4 years
Secondary outcomes:
measure: Measure Metformin Sensitivity in Induced Pluripotent Stem Cells (iPS)
timeFrame: 4 years
measure: Number of Participants With Adverse Events as a Measure of Safety
timeFrame: 4 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Dennis Wigle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: