Study Stopped
Poor accrual and funding ended
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
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2012
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 25, 2012
CompletedFirst Posted
Study publicly available on registry
October 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2019
CompletedResults Posted
Study results publicly available
June 19, 2019
CompletedMarch 10, 2020
March 1, 2020
6.6 years
October 25, 2012
May 28, 2019
March 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Evaluate Feasibility of Patient Randomization, Accrual, and Tissue Collection for Study Conduction
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.
2 years
Number of Participants With 2-year Recurrence Free Survival
To compare the 2-year recurrence free survival (RFS) rate between metformin and observation.
4 years
Secondary Outcomes (2)
Measure Metformin Sensitivity in Induced Pluripotent Stem Cells (iPS)
4 years
Number of Participants With Adverse Events as a Measure of Safety
4 years
Study Arms (2)
Metformin
ACTIVE COMPARATORMetformin 850mg twice a day
Observation
PLACEBO COMPARATORStandard of Care Observation
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Alliance for Clinical Trials in Oncologycollaborator
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study terminated due to poor accrual and funding ended
Results Point of Contact
- Title
- Dennis Wigle, M.D., Ph.D.
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Dennis Wigle, MD, PhD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., P.h.D.
Study Record Dates
First Submitted
October 25, 2012
First Posted
October 30, 2012
Study Start
October 1, 2012
Primary Completion
May 22, 2019
Study Completion
May 22, 2019
Last Updated
March 10, 2020
Results First Posted
June 19, 2019
Record last verified: 2020-03