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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 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: September 9, 2014
Last verified: September 2014

October 25, 2012
September 9, 2014
October 2012
November 2014   (final data collection date for primary outcome measure)
  • Number of Participants Screened [ Designated as safety issue: No ]
    To evaluate the feasibility of patient randomization and accrual 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 Amount of Tissue Collected [ Designated as safety issue: No ]
    To evaluate the feasibility of 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 amount of tissue collected.
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
  • 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.
Same as current
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.

Patients will be identified and enrolled from Thoracic Surgical Clinics. A preoperative bronchoscopy will be performed to obtain systematic bronchial biopsies from defined proximal airway sites. Patients will then undergo surgical resection and tumor tissue and normal lung specimens collected. For patients with bronchial dysplasia postoperatively, starting less than 6 months from the time of surgery, patients will be randomized to receive either 850 mg po BID of metformin or observation. Metformin dosing will include a 4 week ramp up of 850 mg po daily prior to starting the BID dose. Adjuvant platinum-based chemotherapy will be applied at the discretion of treating physicians. Patients found to have bronchial dysplasia at the time of bronchoscopy will undergo follow up bronchoscopy and tissue sampling at 6 months 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
24
May 2015
November 2014   (final data collection date for primary outcome measure)

Inclusion Criteria

  • Suspected or biopsy proven Stage IB-IIIA NSCLC-squamous
  • Coincident bronchial dysplasia and/or carcinoma in situ from at least 1 non-resected location
  • 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
  • Must start Metformin within 6 months 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
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
September 2014

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