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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

A Pilot Study of Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01717482
• Other study ID #: 12-006865
• Status: Terminated
• Phase: Phase 2
• Start date: October 2012
• Est. completion date: May 22, 2019

Study information

• Verified date: March 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: May 22, 2019
• Est. primary completion date: May 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• Metformin

Other:
• Placebo Comparator
Standard of Care Observation

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Alliance for Clinical Trials in Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Primary	Number of Participants With 2-year Recurrence Free Survival	To compare the 2-year recurrence free survival (RFS) rate between metformin and observation.	4 years
Secondary	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.	4 years
Secondary	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.	4 years

External Links

•   Mayo Clinic Clinical Trials