Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer
This study is currently recruiting participants.
Verified November 2012 by Mayo Clinic
Sponsor:
Mayo Clinic
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: November 4, 2012
Last verified: November 2012
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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 Number of Participants Enrolled [ 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 2014 |
| Estimated Primary Completion Date: | November 2013 (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 90 days 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
- 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
Exclusion Criteria
- Prior neoadjuvant therapy
- Existing untreated or prior cancer <5 years from diagnosis
- Diabetic
- 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
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: | November 4, 2012 |
| 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 May 16, 2013