Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2019-05-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Neoplasms Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Metformin

Metformin 850mg twice a day

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Observation

Standard of Care Observation

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type OTHER

Standard of Care Observation

Interventions

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Metformin

Intervention Type DRUG

Placebo Comparator

Standard of Care Observation

Intervention Type OTHER

Other Intervention Names

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Glucophage

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No