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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Mayo Clinic
Sponsor:
Collaborator:
Alliance for Clinical Trials in Oncology
Information provided by (Responsible Party):
Dennis Wigle, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01717482
First received: October 25, 2012
Last updated: April 3, 2015
Last verified: April 2015

October 25, 2012
April 3, 2015
October 2012
January 2017   (final data collection date for primary outcome measure)
  • Evaluate Feasibility of Patient Randomization, Accrual, and Tissue Collection for Study Conduction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    To compare the 2-year recurrence free survival (RFS) rate between metformin and observation.
Number of participants screened, the number enrolled, and the amount of tissue collected [ Designated as safety issue: No ]
To evaluate the feasibility of patient randomization, accrual, and tissue collection in a pilot study of metformin versus observation following resection of stage IB-IIIA lung squamous cell cancer for patients with coincident bronchial dysplasia by collecting data on the number of participants screened, the number enrolled, and the amount of tissue collected.
Complete list of historical versions of study NCT01717482 on ClinicalTrials.gov Archive Site
  • Measure Metformin Sensitivity in iPS (Induced Pluripotent Stem Cells) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    To compare participant adverse events between metformin and observation arms using CTCAE version 4.
  • Frequency of Bronchial Dysplasia [ Designated as safety issue: No ]
    To identify and evaluate the frequency of bronchial dysplasia in patients undergoing resection of non-small cell lung cancer.
  • Effects of Metformin on Ki67 [ Designated as safety issue: No ]
    To evaluate the effects of metformin on Ki67 staining in normal bronchial epithelium and in the progression of squamous dysplasia in patients with resected non-small cell lung cancer.
  • Genomic Alterations [ Designated as safety issue: No ]
    To evaluate genomic alterations associated with the progression of squamous dysplasia, and the resulting effects of metformin administration.
Not Provided
Not Provided
 
Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer
A Pilot Study of Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Lung Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Drug: Metformin
    Other Name: Glucophage
  • Other: Placebo Comparator
    Standard of Care Observation
  • Active Comparator: Metformin
    Metformin 850mg BID
    Intervention: Drug: Metformin
  • Placebo Comparator: Observation
    Standard of Care Observation
    Intervention: Other: Placebo Comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
January 2019
January 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Karlyn E Pierson, RN 507-538-1960 pierson.karlyn@mayo.edu
Contact: Bettie Lechtenberg 877-526-9172 lechtenberg.bettie@mayo.edu
United States
 
NCT01717482
12-006865
No
Dennis Wigle, Mayo Clinic
Mayo Clinic
Alliance for Clinical Trials in Oncology
Principal Investigator: Dennis Wigle, MD, PhD Mayo Clinic
Mayo Clinic
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP