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

Primary Purpose

Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Metformin

Placebo Comparator

About this trial

This is an interventional prevention trial for Lung Neoplasms focused on measuring Bronchoscopy, Metformin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Metformin

Observation

Arm Description

Metformin 850mg twice a day

Standard of Care Observation

Outcomes

Primary Outcome Measures

Evaluate Feasibility of Patient Randomization, Accrual, and Tissue Collection for Study Conduction

To evaluate the feasibility of patient randomization, accrual, and tissue collection in a pilot study of metformin versus observation following resection of stage IA-IIIA lung squamous cell cancer for patients by assessing the reasons patients decline randomization, tracking accrual numbers, and tracking collected tissue and reasons why tissue was not collected.

Number of Participants With 2-year Recurrence Free Survival

To compare the 2-year recurrence free survival (RFS) rate between metformin and observation.

Secondary Outcome Measures

Measure Metformin Sensitivity in Induced Pluripotent Stem Cells (iPS)

To develop the metformin sensitivity index based on iPS cell line metformin sensitivity measurements from the first 20 patients randomized to the metformin arm. We will then To apply the metformin sensitivity index on the remaining 25 patients randomized to metformin and the 45 observation patients (70 patients total) to compare the 2-year RFS rate between metformin-sensitive and metformin-not-sensitive patients.

Number of Participants With Adverse Events as a Measure of Safety

To compare participant adverse events between metformin and observation arms using CTCAE version 4.

Full Information

NCT ID

NCT01717482

First Posted

October 25, 2012

Last Updated

March 2, 2020

Sponsor

Mayo Clinic

Collaborators

Alliance for Clinical Trials in Oncology

1. Study Identification

Unique Protocol Identification Number

NCT01717482

Brief Title

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

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Terminated

Why Stopped

Poor accrual and funding ended

Study Start Date

October 2012 (undefined)

Primary Completion Date

May 22, 2019 (Actual)

Study Completion Date

May 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

Alliance for Clinical Trials in Oncology

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

Keywords

Bronchoscopy, Metformin

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Metformin

Arm Type

Active Comparator

Arm Description

Metformin 850mg twice a day

Arm Title

Observation

Arm Type

Placebo Comparator

Arm Description

Standard of Care Observation

Intervention Type

Drug

Intervention Name(s)

Metformin

Other Intervention Name(s)

Glucophage

Intervention Type

Other

Intervention Name(s)

Placebo Comparator

Intervention Description

Standard of Care Observation

Primary Outcome Measure Information:

Title

Evaluate Feasibility of Patient Randomization, Accrual, and Tissue Collection for Study Conduction

Description

Time Frame

2 years

Title

Number of Participants With 2-year Recurrence Free Survival

Description

To compare the 2-year recurrence free survival (RFS) rate between metformin and observation.

Time Frame

4 years

Secondary Outcome Measure Information:

Title

Measure Metformin Sensitivity in Induced Pluripotent Stem Cells (iPS)

Description

Time Frame

4 years

Title

Number of Participants With Adverse Events as a Measure of Safety

Description

To compare participant adverse events between metformin and observation arms using CTCAE version 4.

Time Frame

4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dennis Wigle, MD, PhD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

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

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