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Metformin in Non Small Cell Lung Cancer (NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02285855
Recruitment Status : Terminated (Poor Accrual)
First Posted : November 7, 2014
Results First Posted : January 6, 2020
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.


Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Metformin Other: Placebo Radiation: Stereotactic body Radiotherapy (SBRT) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Tumor Mutation Status Will Predict Metabolic Response to Metformin in Non Small Cell Lung Cancer (NSCLC)
Actual Study Start Date : February 20, 2015
Actual Primary Completion Date : January 5, 2019
Actual Study Completion Date : January 5, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Stereotactic body Radiotherapy (SBRT) + Metformin
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.
Drug: Metformin
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.
Other Name: Metformin ER

Radiation: Stereotactic body Radiotherapy (SBRT)
SBRT delivered per standard of care practice as determined by participant's physician.
Other Names:
  • SBRT
  • XRT

Placebo Comparator: Stereotactic Body Radiotherapy (SBRT) + Placebo
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.
Other: Placebo
Placebo treatment given 3 weeks prior to SBRT treatment and for 1 week during SBRT treatment. Placebo administered by mouth three times a day.
Other Name: Sugar pill

Radiation: Stereotactic body Radiotherapy (SBRT)
SBRT delivered per standard of care practice as determined by participant's physician.
Other Names:
  • SBRT
  • XRT




Primary Outcome Measures :
  1. RECIST and PERCIST Tumor Response [ Time Frame: From baseline (prior to metformin start) to Post-Radiotherapy (RT) Treatment, assessed up to 6 months ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285855


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Stephen G. Chun, MD M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:
Study Protocol  [PDF] January 26, 2017
Statistical Analysis Plan  [PDF] January 26, 2017

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02285855    
Other Study ID Numbers: 2014-0255
NCI-2015-00287 ( Registry Identifier: NCI CTRP )
First Posted: November 7, 2014    Key Record Dates
Results First Posted: January 6, 2020
Last Update Posted: January 6, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
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
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs