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Trial record 9 of 23 for:    "Lung Disease" | "Metformin"

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

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ClinicalTrials.gov Identifier: NCT01717482
Recruitment Status : Terminated (Poor accrual and funding ended)
First Posted : October 30, 2012
Results First Posted : June 19, 2019
Last Update Posted : June 19, 2019
Sponsor:
Collaborator:
Alliance for Clinical Trials in Oncology
Information provided by (Responsible Party):
Dennis Wigle, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE October 25, 2012
First Posted Date  ICMJE October 30, 2012
Results First Submitted Date  ICMJE May 28, 2019
Results First Posted Date  ICMJE June 19, 2019
Last Update Posted Date June 19, 2019
Study Start Date  ICMJE October 2012
Actual Primary Completion Date May 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2015)
  • Evaluate Feasibility of Patient Randomization, Accrual, and Tissue Collection for Study Conduction [ Time Frame: 2 years ]
    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 ]
    To compare the 2-year recurrence free survival (RFS) rate between metformin and observation.
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2012)
Number of participants screened, the number enrolled, and the amount of tissue collected
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.
Change History Complete list of historical versions of study NCT01717482 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
  • Measure Metformin Sensitivity in Induced Pluripotent Stem Cells (iPS) [ Time Frame: 4 years ]
    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 ]
    To compare participant adverse events between metformin and observation arms using CTCAE version 4.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2012)
  • Frequency of Bronchial Dysplasia
    To identify and evaluate the frequency of bronchial dysplasia in patients undergoing resection of non-small cell lung cancer.
  • Effects of Metformin on Ki67
    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
    To evaluate genomic alterations associated with the progression of squamous dysplasia, and the resulting effects of metformin administration.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer
Official Title  ICMJE A Pilot Study of Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer
Brief 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.
Detailed Description Participants will need to be scheduled to undergo a surgical resection of their lung cancer at the Mayo Clinic in Rochester, Minnesota. 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Lung Neoplasms
  • Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: Metformin
    Other Name: Glucophage
  • Other: Placebo Comparator
    Standard of Care Observation
Study Arms  ICMJE
  • Active Comparator: Metformin
    Metformin 850mg twice a day
    Intervention: Drug: Metformin
  • Placebo Comparator: Observation
    Standard of Care Observation
    Intervention: Other: Placebo Comparator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 28, 2019)
6
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2012)
24
Actual Study Completion Date  ICMJE May 22, 2019
Actual Primary Completion Date May 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Suspected or biopsy proven Stage IA-IIIA lung squamous cell carcinoma (SCC) (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
  • Eastern Cooperative Oncology Group (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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01717482
Other Study ID Numbers  ICMJE 12-006865
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dennis Wigle, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Alliance for Clinical Trials in Oncology
Investigators  ICMJE
Principal Investigator: Dennis Wigle, MD, PhD Mayo Clinic
PRS Account Mayo Clinic
Verification Date May 2019

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