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Metformin in Non Small Cell Lung Cancer (NSCLC)

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Metformin
Placebo
Stereotactic body Radiotherapy (SBRT)
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Lung Cancer, Non small cell lung cancer, Stereotactic body radiotherapy, SBRT, XRT, Radiation therapy, Metformin, Metformin ER, Placebo, Sugar pill, Lung adenocarcinoma, Genotypes, Genetic mutations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with pathologic diagnosis of lung NSCLC or squamous cell carcinoma.
  2. Patients are to be treated with hypofractionated RT.
  3. Patient is not a surgical candidate due to medical comorbidities determined by a thoracic surgeon or patient refusal
  4. Patient plans to receive treatment at MD Anderson
  5. Patients must sign informed consent
  6. Patient must have adequate renal function within 30 days prior to registration, defined as serum creatinine within normal institutional limits or creatinine clearance at least 60 ml/min

Exclusion Criteria:

  1. Patient has: random glucose >200 mg/dl or is taking an oral hypoglycemic agent or insulin at the time of study entry
  2. Patient has a history of lactic acidosis, chronic kidney disease or a creatinine >/= 1.2 mg/dl
  3. Women who are pregnant or breast feeding, as treatment involves unforeseeable risks to the participant, embryo, fetus, or nursing infant
  4. Patients with history of allergic reaction to metformin

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Stereotactic body Radiotherapy (SBRT) + Metformin

Stereotactic Body Radiotherapy (SBRT) + Placebo

Arm Description

Participants randomized to Metformin treatment receive Metformin for 3 weeks prior to SBRT treatment and for 1 week during SBRT treatment. Metformin administered at a dose of 2000 mg by mouth in divided dose daily (500 mg am, 1000 mg noon, 500 mg pm). To reduce GI toxicity, participants start Metformin at 1000 mg daily in a divided dose (500mg am, 500 mg pm) for 1 week. SBRTdelivered per standard of care practice.

Participants randomized to placebo treatment 3 weeks prior to SBRT treatment and for 1 week during SBRT treatment. Placebo administered by mouth three times a day. SBRT delivered per standard of care practice.

Outcomes

Primary Outcome Measures

RECIST and PERCIST Tumor Response
The primary objective is the effect of metformin on response in NSCLC patients treated with hypofractionated RT. All patients will receive FDG-PET/CT scan at baseline (prior to metformin start), prior to RT and at 6 months (+/- 30 days) following RT. PET/CT imaging using [18F]-2-fluoro-2-deoxyglucose positron emission tomography (18F-FDG), using a standard approved radiopharmaceutical dose and administration selected by the nuclear medicine physician (120 min). Response will be determined at 6 months post-treatment via relative change from pre-treatment tumor by Response Evaluation Criteria in Solid Tumor (RECIST) by complete response (CR), partial response (PR) and stable disease (SD) and PET Response Criteria in Solid Tumors (PERCIST) by stable metabolic disease (SMD), progressive metabolic disease (PMD) and complete metabolic response(CMR).

Secondary Outcome Measures

Full Information

First Posted
November 5, 2014
Last Updated
December 17, 2019
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02285855
Brief Title
Metformin in Non Small Cell Lung Cancer (NSCLC)
Official Title
Tumor Mutation Status Will Predict Metabolic Response to Metformin in Non Small Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Poor Accrual
Study Start Date
February 20, 2015 (Actual)
Primary Completion Date
January 5, 2019 (Actual)
Study Completion Date
January 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical research study is to learn if giving metformin in combination with radiation therapy is more effective than radiation therapy alone. In this study, participants will receive either metformin or a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect. This is an investigational study. Metformin is FDA approved for the treatment of diabetes. Its use in this study to be given with radiation therapy to treat lung cancer is investigational. The study doctor can explain how the study drug is designed to work. Up to 70 participants will be enrolled in this study. All will take part at MD Anderson.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung Cancer, Non small cell lung cancer, Stereotactic body radiotherapy, SBRT, XRT, Radiation therapy, Metformin, Metformin ER, Placebo, Sugar pill, Lung adenocarcinoma, Genotypes, Genetic mutations

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic body Radiotherapy (SBRT) + Metformin
Arm Type
Experimental
Arm Description
Participants randomized to Metformin treatment receive Metformin for 3 weeks prior to SBRT treatment and for 1 week during SBRT treatment. Metformin administered at a dose of 2000 mg by mouth in divided dose daily (500 mg am, 1000 mg noon, 500 mg pm). To reduce GI toxicity, participants start Metformin at 1000 mg daily in a divided dose (500mg am, 500 mg pm) for 1 week. SBRTdelivered per standard of care practice.
Arm Title
Stereotactic Body Radiotherapy (SBRT) + Placebo
Arm Type
Placebo Comparator
Arm Description
Participants randomized to placebo treatment 3 weeks prior to SBRT treatment and for 1 week during SBRT treatment. Placebo administered by mouth three times a day. SBRT delivered per standard of care practice.
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Metformin ER
Intervention Description
Metformin treatment given at a dose of 2000 mg by mouth in divided dose daily (500 mg am, 1000 mg noon, 500 mg pm). To reduce GI toxicity, participants start Metformin at 1000 mg daily in a divided dose (500mg am, 500 mg pm) for 1 week.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
Placebo treatment given 3 weeks prior to SBRT treatment and for 1 week during SBRT treatment. Placebo administered by mouth three times a day.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic body Radiotherapy (SBRT)
Other Intervention Name(s)
SBRT, XRT
Intervention Description
SBRT delivered per standard of care practice as determined by participant's physician.
Primary Outcome Measure Information:
Title
RECIST and PERCIST Tumor Response
Description
The primary objective is the effect of metformin on response in NSCLC patients treated with hypofractionated RT. All patients will receive FDG-PET/CT scan at baseline (prior to metformin start), prior to RT and at 6 months (+/- 30 days) following RT. PET/CT imaging using [18F]-2-fluoro-2-deoxyglucose positron emission tomography (18F-FDG), using a standard approved radiopharmaceutical dose and administration selected by the nuclear medicine physician (120 min). Response will be determined at 6 months post-treatment via relative change from pre-treatment tumor by Response Evaluation Criteria in Solid Tumor (RECIST) by complete response (CR), partial response (PR) and stable disease (SD) and PET Response Criteria in Solid Tumors (PERCIST) by stable metabolic disease (SMD), progressive metabolic disease (PMD) and complete metabolic response(CMR).
Time Frame
From baseline (prior to metformin start) to Post-Radiotherapy (RT) Treatment, assessed up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with pathologic diagnosis of lung NSCLC or squamous cell carcinoma. Patients are to be treated with hypofractionated RT. Patient is not a surgical candidate due to medical comorbidities determined by a thoracic surgeon or patient refusal Patient plans to receive treatment at MD Anderson Patients must sign informed consent Patient must have adequate renal function within 30 days prior to registration, defined as serum creatinine within normal institutional limits or creatinine clearance at least 60 ml/min Exclusion Criteria: Patient has: random glucose >200 mg/dl or is taking an oral hypoglycemic agent or insulin at the time of study entry Patient has a history of lactic acidosis, chronic kidney disease or a creatinine >/= 1.2 mg/dl Women who are pregnant or breast feeding, as treatment involves unforeseeable risks to the participant, embryo, fetus, or nursing infant Patients with history of allergic reaction to metformin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen G. Chun, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31990759
Citation
Chun SG, Liao Z, Jeter MD, Chang JY, Lin SH, Komaki RU, Guerrero TM, Mayo RC, Korah BM, Koshy SM, Heymach JV, Koong AC, Skinner HD. Metabolic Responses to Metformin in Inoperable Early-stage Non-Small Cell Lung Cancer Treated With Stereotactic Radiotherapy: Results of a Randomized Phase II Clinical Trial. Am J Clin Oncol. 2020 Apr;43(4):231-235. doi: 10.1097/COC.0000000000000632.
Results Reference
derived
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

Learn more about this trial

Metformin in Non Small Cell Lung Cancer (NSCLC)

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