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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 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: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Drug: Metformin
Other: Placebo Comparator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Pilot Study of Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 24
Study Start Date: October 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metformin
Metformin 850mg BID
Drug: Metformin
Other Name: Glucophage
Placebo Comparator: Observation
Standard of Care Observation
Other: Placebo Comparator
Standard of Care Observation

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717482

Contacts
Contact: Karlyn E Pierson, RN 507-538-1960 pierson.karlyn@mayo.edu
Contact: Susan Schrage, RN 507-538-7168 schrage.susan@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Alliance for Clinical Trials in Oncology
Investigators
Principal Investigator: Dennis Wigle, MD, PhD Mayo Clinic
  More Information

No publications provided

Responsible Party: Dennis Wigle, M.D., P.h.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01717482     History of Changes
Other Study ID Numbers: 12-006865
Study First Received: October 25, 2012
Last Updated: February 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Bronchoscopy
Metformin

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014