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
  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:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2017 (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:

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.

  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 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
  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: Bettie Lechtenberg 877-526-9172 lechtenberg.bettie@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: April 3, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Bronchoscopy
Metformin

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

ClinicalTrials.gov processed this record on August 03, 2015