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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIPreventionActiveOver 18Other12-006865
NCT01717482

Trial Description

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Mayo Clinic Cancer Center

Alliance for Clinical Trials in Oncology

Dennis WiglePrincipal Investigator

Karlyn E Pierson, RNPh: 507-538-1960
  Email: pierson.karlyn@mayo.edu

Trial Sites

U.S.A.
Minnesota
  Rochester
 Mayo Clinic Cancer Center

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01717482
ClinicalTrials.gov processed this data on April 09, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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