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Chemotherapy and Radiation Therapy with or without Metformin Hydrochloride in Treating Patients with Stage III Non-small Cell Lung Cancer

Trial Status: Closed to Accrual and Intervention

This randomized phase II trial studies how well chemotherapy and radiation therapy given with or without metformin hydrochloride works in treating patients with stage III non-small cell lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Metformin hydrochloride may shrink tumors and keep them from coming back. It is not yet known whether chemotherapy and radiation therapy is more effective when given with or without metformin hydrochloride in treating stage III non-small cell lung cancer.

Inclusion Criteria

  • Pathologically (histologically or cytologically) proven diagnosis of stage IIIA or IIIB non-small cell lung cancer within 84 days of registration; eligible histologies include adenocarcinoma, adenosquamous, large cell carcinoma, squamous carcinoma, non-lobar and non-diffuse bronchoalveolar cell carcinoma or non-small cell lung cancer not otherwise specified [NOS])
  • Patients must have measurable disease
  • Patients must have unresectable disease, be medically inoperable, or unwilling to undergo surgical management
  • Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup: * History/physical examination, including documentation of height, weight, body surface area [BSA], and vital signs, within 30 days prior to registration * Computed tomography (CT) with IV contrast or magnetic resonance imaging (MRI) imaging (if CT scan with contrast is medically contraindicated) of the lung and upper abdomen through the adrenal glands, required within 45 days prior to registration (recommended within 30 days prior to registration * MRI of the brain with contrast (or CT with contrast if MRI is medically contraindicated) within 45 days prior to registration; note: the use of intravenous contrast is required for the MRI or CT; an MRI without contrast is only permitted if the patient has a contrast allergy * Whole-body fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)/CT required within 45 days prior to registration (recommended within 30 days prior to registration; note: patients do not need to have a separate CT of the chest and upper abdomen with contrast if PET/CT imaging includes a high quality CT with contrast
  • Zubrod performance status 0-1
  • Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (obtained within 14 days prior to registration on study)
  • Platelets >= 100,000 cells/mm^3 (obtained within 14 days prior to registration on study)
  • Hemoglobin >= 8.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable) (obtained within 14 days prior to registration on study)
  • Serum creatinine within normal institutional limits or creatinine clearance must be at least 60 ml/min (obtained within 14 days prior to registration on study)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for the institution (obtained within 14 days prior to registration on study)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN for the institution (obtained within 14 days prior to registration on study)
  • Alkaline phosphatase =< 2.5 x ULN for the institution (obtained within 14 days prior to registration on study)
  • Fasting blood glucose =< 125 mg/dL within 14 days prior to registration
  • Serum albumin > 3.0 g/dl within 14 days prior to registration
  • For women of childbearing potential, a serum pregnancy test within 72 hours prior to registration
  • Patients with post-obstructive pneumonia are eligible provided they no longer require intravenous antibiotics at registration
  • Patients must be at least 3 weeks from prior thoracotomy (if performed)
  • If a pleural effusion is present, the following criteria must be met at registration to exclude malignant involvement (incurable M1a disease): * When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative * Effusions that are minimal (i.e. not visible under ultrasound guidance) and that are too small to safely tap are eligible
  • Women of childbearing potential and male participants must practice adequate contraception throughout the study
  • Patient must provide study specific informed consent prior to study entry

Exclusion Criteria

  • Patients with mixed small cell and non-small cell histologies
  • Patients with distant metastasis
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Patients currently using metformin (metformin hydrochloride), other oral hypoglycemic agents or insulin
  • Patients with any history of allergic reaction to paclitaxel or other taxanes or carboplatin
  • Patients with a history of chronic kidney disease or lactic acidosis
  • Patients with >= 10% weight loss within the past month
  • Severe, active co-morbidity, defined as follows: * Diagnosis of type I or type II diabetes mellitus * Uncontrolled neuropathy >= grade 2 regardless of cause * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration * Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease * Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol * End-stage renal disease (ie, on dialysis or dialysis has been recommended)
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception

Alabama

Tuscaloosa
Lewis and Faye Manderson Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: James Curtis Tucker
Phone: 800-338-2948

Arizona

Tucson
Banner University Medical Center - Tucson
Status: CLOSED_TO_ACCRUAL
Contact: Sun K Yi
Phone: 520-626-9008

California

Auburn
Sutter Cancer Centers Radiation Oncology Services-Auburn
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Uwe Jones
Phone: 415-209-2686
Cameron Park
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Uwe Jones
Phone: 415-209-2686
Castro Valley
Eden Hospital Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Uwe Jones
Phone: 415-209-2686
La Jolla
UC San Diego Moores Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: James John Urbanic
Phone: 858-822-5354
Modesto
Memorial Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Uwe Jones
Phone: 415-209-2686
Oakland
Kaiser Permanente Oakland-Broadway
Status: CLOSED_TO_ACCRUAL
Contact: Samantha Andrews Seaward
Phone: 626-564-3455
Rancho Cordova
Kaiser Permanente-Rancho Cordova Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Samantha Andrews Seaward
Phone: 626-564-3455
Rohnert Park
Rohnert Park Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Samantha Andrews Seaward
Phone: 626-564-3455
Roseville
Sutter Cancer Centers Radiation Oncology Services-Roseville
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Uwe Jones
Phone: 415-209-2686
The Permanente Medical Group-Roseville Radiation Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Samantha Andrews Seaward
Phone: 626-564-3455
Sacramento
South Sacramento Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Samantha Andrews Seaward
Phone: 626-564-3455
Sutter Medical Center Sacramento
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Uwe Jones
Phone: 415-209-2686
San Francisco
UCSF Medical Center-Mount Zion
Status: CLOSED_TO_ACCRUAL
Contact: Adam Garsa
Phone: 877-827-3222
South San Francisco
Kaiser Permanente Cancer Treatment Center
Status: CLOSED_TO_ACCRUAL
Contact: Samantha Andrews Seaward
Phone: 626-564-3455
Vacaville
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Status: CLOSED_TO_ACCRUAL
Contact: Christopher Uwe Jones
Phone: 415-209-2686

Colorado

Aurora
University of Colorado Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Brian Dennis Kavanagh
Phone: 720-848-0650
Colorado Springs
Penrose-Saint Francis Healthcare
Status: CLOSED_TO_ACCRUAL
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
UCHealth Memorial Hospital Central
Status: CLOSED_TO_ACCRUAL
Contact: Brian Dennis Kavanagh
Phone: 720-848-0650
Englewood
Swedish Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Keren Sturtz
Phone: 303-777-2663
Greeley
North Colorado Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Keren Sturtz
Phone: 303-777-2663
Loveland
McKee Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Keren Sturtz
Phone: 303-777-2663
Wheat Ridge
SCL Health Lutheran Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Keren Sturtz
Phone: 303-777-2663

Delaware

Newark
Christiana Care Health System-Christiana Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Gregory Andrew Masters
Phone: 302-733-6227

Florida

Orlando
Orlando Health Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Justin M Rineer
Phone: 321-841-7246
Palatka
Cancer Center of Putnam
Status: CLOSED_TO_ACCRUAL
Contact: Anand Mathai Kuruvilla
Phone: 904-861-8574

Georgia

Atlanta
Piedmont Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Adam Wayne Nowlan
Phone: 404-425-7943
Columbus
John B Amos Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Andrew W. Pippas
Phone: 706-660-6404
Decatur
Dekalb Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Sharad Anant Ghamande
Phone: 706-721-1663
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: CLOSED_TO_ACCRUAL
Contact: Howard A. Zaren
Phone: 800-622-6877
Memorial Health University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Harvey Charles Lebos
Phone: 912-354-6187

Hawaii

Aiea
The Cancer Center of Hawaii-Pali Momi
Status: CLOSED_TO_ACCRUAL
Contact: Kenneth N.M. Sumida
Phone: 808-524-6115
Honolulu
Queen's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Kenneth N.M. Sumida
Phone: 808-524-6115
The Cancer Center of Hawaii-Liliha
Status: CLOSED_TO_ACCRUAL
Contact: Kenneth N.M. Sumida
Phone: 808-524-6115

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: CLOSED_TO_ACCRUAL
Contact: Philip J. Stella
Phone: 734-712-4673
Post Falls
Kootenai Clinic Cancer Services - Post Falls
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin T. Marchello
Phone: 800-648-6274
Twin Falls
Saint Luke's Cancer Institute - Twin Falls
Status: CLOSED_TO_ACCRUAL
Contact: Paul G. Montgomery
Phone: 208-381-3376

Illinois

Arlington Heights
Northwest Community Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Stephen Schaeffer Nigh
Phone: 847-618-4968
Chicago
John H Stroger Jr Hospital of Cook County
Status: CLOSED_TO_ACCRUAL
Contact: Thomas E. Lad
Phone: 312-864-6000
Rush University Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Gaurav Marwaha
Phone: 312-942-5498
Decatur
Decatur Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: James Lloyd Wade
Phone: 217-876-4740
Mount Vernon
Good Samaritan Regional Health Center
Status: CLOSED_TO_ACCRUAL
Contact: Jay W. Carlson
Phone: 800-821-7532
Pekin
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Status: CLOSED_TO_ACCRUAL
Contact: James Lloyd Wade
Phone: 217-876-4740
Peoria
Methodist Medical Center of Illinois
Status: CLOSED_TO_ACCRUAL
Contact: James Lloyd Wade
Phone: 217-876-4740
OSF Saint Francis Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: James Lloyd Wade
Phone: 217-876-4740
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: James Lloyd Wade
Phone: 217-876-4740
Springfield
Memorial Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: James Lloyd Wade
Phone: 217-876-4740
Urbana
Carle Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Vamsi Krishna Vasireddy
Phone: 800-446-5532

Indiana

Bloomington
IU Health Bloomington
Status: CLOSED_TO_ACCRUAL
Contact: Jeffrey Paul Allerton
Phone: 812-353-2831
Fort Wayne
Parkview Hospital Randallia
Status: CLOSED_TO_ACCRUAL
Contact: Brian K. Chang
Phone: 260-373-8888
Radiation Oncology Associates PC
Status: CLOSED_TO_ACCRUAL
Contact: Brian K. Chang
Phone: 260-373-8888
Indianapolis
Franciscan Health Indianapolis
Status: CLOSED_TO_ACCRUAL
Contact: Michael Scott-Soon Eaton
Phone: 317-851-2555

Iowa

Cedar Rapids
Mercy Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Deborah Weil Wilbur
Phone: 515-241-3305

Kansas

Kansas City
University of Kansas Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Joshua Matthew Varghis Mammen
Phone: 913-945-7552
Lawrence
Lawrence Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Shaker R. Dakhil
Phone: 316-268-5374
Overland Park
University of Kansas Cancer Center-Overland Park
Status: CLOSED_TO_ACCRUAL
Contact: Joshua Matthew Varghis Mammen
Phone: 913-945-7552
Wichita
Ascension Via Christi Hospitals Wichita
Status: CLOSED_TO_ACCRUAL
Contact: Shaker R. Dakhil
Phone: 316-268-5374
Wesley Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Shaker R. Dakhil
Phone: 316-268-5374

Kentucky

Elizabethtown
Baptist Health Hardin
Status: CLOSED_TO_ACCRUAL
Contact: Amy Schell
Phone: 859-260-6425
Lexington
Baptist Health Lexington
Status: CLOSED_TO_ACCRUAL
Contact: Amy Schell
Phone: 859-260-6425
University of Kentucky / Markey Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Ronald Charles McGarry
Phone: 859-257-3379

Louisiana

Baton Rouge
LSU Health Baton Rouge-North Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Augusto C. Ochoa
Phone: 504-568-2428
Louisiana Hematology Oncology Associates LLC
Status: CLOSED_TO_ACCRUAL
Contact: Augusto C. Ochoa
Phone: 504-568-2428
Mary Bird Perkins Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Augusto C. Ochoa
Phone: 504-568-2428
Our Lady of the Lake Physicians Group - Medical Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Augusto C. Ochoa
Phone: 504-568-2428
Covington
Mary Bird Perkins Cancer Center - Covington
Status: CLOSED_TO_ACCRUAL
Contact: Augusto C. Ochoa
Phone: 504-568-2428
Houma
Mary Bird Perkins Cancer Center - Houma
Status: CLOSED_TO_ACCRUAL
Contact: Augusto C. Ochoa
Phone: 504-568-2428

Maine

Scarborough
Maine Medical Center- Scarborough Campus
Status: CLOSED_TO_ACCRUAL
Contact: Ian Jared Bristol
Phone: 207-396-8090

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Steven J. Feigenberg
Phone: 800-888-8823
Bel Air
UM Upper Chesapeake Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Mark V. Mishra
Phone: 443-643-3010
Glen Burnie
UM Baltimore Washington Medical Center / Tate Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Steven J. Feigenberg
Phone: 800-888-8823
Salisbury
TidalHealth Peninsula Regional
Status: CLOSED_TO_ACCRUAL
Contact: John Romeo Mansueti
Phone: 866-922-6237

Massachusetts

Boston
Boston Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Timothy Patrick Cooley
Phone: 617-638-8265
Lowell
Lowell General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Blair Ardman
Phone: 978-788-7084

Michigan

Detroit
Henry Ford Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Eleanor M. Walker
Phone: 313-916-1784
Flint
McLaren Cancer Institute-Flint
Status: CLOSED_TO_ACCRUAL
Contact: Kiran Devisetty
Phone: 313-576-9363
Grand Rapids
Mercy Health Saint Mary's
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Spectrum Health at Butterworth Campus
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Kalamazoo
West Michigan Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Lapeer
McLaren Cancer Institute-Lapeer Region
Status: CLOSED_TO_ACCRUAL
Contact: Kiran Devisetty
Phone: 313-576-9363
Mount Clemens
McLaren Cancer Institute-Macomb
Status: CLOSED_TO_ACCRUAL
Contact: Kiran Devisetty
Phone: 313-576-9363
Mount Pleasant
McLaren Cancer Institute-Central Michigan
Status: CLOSED_TO_ACCRUAL
Contact: Kiran Devisetty
Phone: 313-576-9363
Muskegon
Mercy Health Mercy Campus
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Owosso
McLaren Cancer Institute-Owosso
Status: CLOSED_TO_ACCRUAL
Contact: Kiran Devisetty
Phone: 313-576-9363
Petoskey
McLaren Cancer Institute-Northern Michigan
Status: CLOSED_TO_ACCRUAL
Contact: Kiran Devisetty
Phone: 313-576-9363
Pontiac
Saint Joseph Mercy Oakland
Status: CLOSED_TO_ACCRUAL
Contact: Philip J. Stella
Phone: 734-712-4673
Royal Oak
William Beaumont Hospital-Royal Oak
Status: CLOSED_TO_ACCRUAL
Contact: Joseph Mark Anderson
Phone: 248-551-7695
Saint Joseph
Lakeland Medical Center Saint Joseph
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Troy
William Beaumont Hospital - Troy
Status: CLOSED_TO_ACCRUAL
Contact: Joseph Mark Anderson
Phone: 248-551-7695

Minnesota

Bemidji
Sanford Joe Lueken Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Preston D. Steen
Phone: 701-234-6161
Coon Rapids
Mercy Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517
Duluth
Saint Luke's Hospital of Duluth
Status: CLOSED_TO_ACCRUAL
Contact: Basem Said Goueli
Phone: 218-249-7825
Edina
Fairview Southdale Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517
Minneapolis
Abbott-Northwestern Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517
Hennepin County Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517
Saint Paul
Regions Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517
United Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517
Willmar
Rice Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517

Mississippi

Jackson
University of Mississippi Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Jennifer Thomas Eubanks
Phone: 601-815-6700

Missouri

Cape Girardeau
Saint Francis Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: James Lloyd Wade
Phone: 217-876-4740
Southeast Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: James Lloyd Wade
Phone: 217-876-4740
Kansas City
North Kansas City Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Joshua Matthew Varghis Mammen
Phone: 913-945-7552
The University of Kansas Cancer Center-South
Status: CLOSED_TO_ACCRUAL
Contact: Joshua Matthew Varghis Mammen
Phone: 913-945-7552
University of Kansas Cancer Center - North
Status: CLOSED_TO_ACCRUAL
Contact: Joshua Matthew Varghis Mammen
Phone: 913-945-7552
Lee's Summit
University of Kansas Cancer Center - Lee's Summit
Status: CLOSED_TO_ACCRUAL
Contact: Joshua Matthew Varghis Mammen
Phone: 913-945-7552
Rolla
Delbert Day Cancer Institute at PCRMC
Status: CLOSED_TO_ACCRUAL
Contact: Jay W. Carlson
Phone: 800-821-7532
Saint Louis
Mercy Hospital Saint Louis
Status: CLOSED_TO_ACCRUAL
Contact: Jay W. Carlson
Phone: 800-821-7532
Missouri Baptist Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: James Lloyd Wade
Phone: 217-876-4740
Springfield
CoxHealth South Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Jay W. Carlson
Phone: 800-821-7532

Montana

Billings
Billings Clinic Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin T. Marchello
Phone: 800-648-6274
Missoula
Community Medical Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Benjamin T. Marchello
Phone: 800-648-6274

Nebraska

Grand Island
CHI Health Saint Francis
Status: CLOSED_TO_ACCRUAL
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
Kearney
CHI Health Good Samaritan
Status: CLOSED_TO_ACCRUAL
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
Omaha
Nebraska Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Tien-Shew William Huang
Phone: 402-354-5144
University of Nebraska Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Weining Zhen
Phone: 402-559-8555

New Hampshire

Dover
Wentworth-Douglass Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Barbara Shea Civiello
Phone: 603-740-2150
Lebanon
Dartmouth Hitchcock Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Alan Charles Hartford
Phone: 800-639-6918

New Jersey

Mount Holly
Virtua Memorial
Status: CLOSED_TO_ACCRUAL
Contact: Lemuel S. Ariaratnam
Phone: 609-914-6762
Toms River
Community Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: David J. D'Ambrosio
Phone: 732-818-3882
Voorhees
Virtua Voorhees
Status: CLOSED_TO_ACCRUAL
Contact: Lemuel S. Ariaratnam
Phone: 609-914-6762

New Mexico

Albuquerque
New Mexico Oncology Hematology Consultants
Status: CLOSED_TO_ACCRUAL
Contact: Thomas McNeil Schroeder
Phone: 505-925-0366
University of New Mexico Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Thomas McNeil Schroeder
Phone: 505-925-0366

New York

Brooklyn
New York-Presbyterian / Brooklyn Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Sameer Rafla-Demetrious
Phone: 718-780-5240
Rochester
University of Rochester
Status: CLOSED_TO_ACCRUAL
Contact: Yuhchyau Chen
Phone: 585-275-5830

North Carolina

Belmont
Gaston Hematology and Oncology Associates-Belmont
Status: CLOSED_TO_ACCRUAL
Contact: William J. Charles
Phone: 704-865-5210
Gastonia
CaroMont Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: William J. Charles
Phone: 704-865-5210
Gaston Hematology and Oncology Associates
Status: CLOSED_TO_ACCRUAL
Contact: William J. Charles
Phone: 704-865-5210
Pinehurst
FirstHealth of the Carolinas-Moore Regional Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Charles S. Kuzma
Phone: 910-715-2200

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Preston D. Steen
Phone: 701-234-6161
Fargo
Sanford Roger Maris Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Preston D. Steen
Phone: 701-234-6161

Ohio

Beachwood
UHHS-Chagrin Highlands Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Mitchell Machtay
Phone: 800-641-2422
Canton
Aultman Health Foundation
Status: CLOSED_TO_ACCRUAL
Contact: Shruti Trehan
Phone: 330-363-6891
Cleveland Clinic Mercy Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Mitchell Haut
Phone: 888-293-4673
Chardon
Geauga Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Mitchell Machtay
Phone: 800-641-2422
Chillicothe
Adena Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Timothy David Moore
Phone: 614-488-2745
Cincinnati
University of Cincinnati Cancer Center-UC Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Kevin Patrick Redmond
Phone: 513-558-4553
Cleveland
Case Western Reserve University
Status: CLOSED_TO_ACCRUAL
Contact: Mitchell Machtay
Phone: 800-641-2422
Cleveland Clinic Cancer Center / Fairview Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Gregory M. M. Videtic
Phone: 866-223-8100
Cleveland Clinic Foundation
Status: CLOSED_TO_ACCRUAL
Contact: Gregory M. M. Videtic
Phone: 866-223-8100
Columbus
Mount Carmel Health Center West
Status: CLOSED_TO_ACCRUAL
Contact: Timothy David Moore
Phone: 614-488-2745
Ohio State University Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Jose Gilberto Bazan
Phone: 800-293-5066
Riverside Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Timothy David Moore
Phone: 614-488-2745
The Mark H Zangmeister Center
Status: CLOSED_TO_ACCRUAL
Contact: Timothy David Moore
Phone: 614-488-2745
Dayton
Good Samaritan Hospital - Dayton
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Elyria
Mercy Cancer Center-Elyria
Status: CLOSED_TO_ACCRUAL
Contact: Mitchell Machtay
Phone: 800-641-2422
Independence
Cleveland Clinic Cancer Center Independence
Status: CLOSED_TO_ACCRUAL
Contact: Gregory M. M. Videtic
Phone: 866-223-8100
Kettering
Kettering Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Howard M. Gross
Phone: 937-775-1350
Mayfield Heights
Hillcrest Hospital Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Gregory M. M. Videtic
Phone: 866-223-8100
Mentor
UH Seidman Cancer Center at Lake Health Mentor Campus
Status: CLOSED_TO_ACCRUAL
Contact: Mitchell Machtay
Phone: 800-641-2422
Middleburg Heights
UH Seidman Cancer Center at Southwest General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Mitchell Machtay
Phone: 800-641-2422
Newark
Newark Radiation Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Timothy David Moore
Phone: 614-488-2745
Parma
University Hospitals Parma Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Mitchell Machtay
Phone: 800-641-2422
Portsmouth
Southern Ohio Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Timothy David Moore
Phone: 614-488-2745
Sandusky
North Coast Cancer Care
Status: CLOSED_TO_ACCRUAL
Contact: Gregory M. M. Videtic
Phone: 866-223-8100
UH Seidman Cancer Center at Firelands Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Mitchell Machtay
Phone: 800-641-2422
Strongsville
Cleveland Clinic Cancer Center Strongsville
Status: CLOSED_TO_ACCRUAL
Contact: Gregory M. M. Videtic
Phone: 866-223-8100
West Chester
University of Cincinnati Cancer Center-West Chester
Status: CLOSED_TO_ACCRUAL
Contact: Kevin Patrick Redmond
Phone: 513-558-4553
Westlake
UHHS-Westlake Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Mitchell Machtay
Phone: 800-641-2422
Wooster
Cleveland Clinic Wooster Family Health and Surgery Center
Status: CLOSED_TO_ACCRUAL
Contact: Gregory M. M. Videtic
Phone: 866-223-8100
Zanesville
Genesis Healthcare System Cancer Care Center
Status: CLOSED_TO_ACCRUAL
Contact: Timothy David Moore
Phone: 614-488-2745

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: CLOSED_TO_ACCRUAL
Contact: Terence S. Herman
Phone: 405-271-8777

Pennsylvania

Abington
Jefferson Abington Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Wayne H. Pinover
Phone: 215-481-2402
Danville
Geisinger Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Rajiv Panikkar
Phone: 570-271-5251
Dunmore
Northeast Radiation Oncology Center
Status: CLOSED_TO_ACCRUAL
Contact: Bo Lu
Phone: 215-955-6084
Erie
UPMC Hillman Cancer Center Erie
Status: CLOSED_TO_ACCRUAL
Contact: Jan M. Rothman
Phone: 814-838-0448
Philadelphia
Thomas Jefferson University Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Bo Lu
Phone: 215-955-6084
Pittsburgh
UPMC-Shadyside Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Brian J. Karlovits
Phone: 412-621-2334
West Reading
Reading Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Terrence Paul Cescon
Phone: 610-988-9323
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Rajiv Panikkar
Phone: 570-271-5251
Wynnewood
Lankenau Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Albert S. DeNittis
Phone: 484-476-2649

South Carolina

Anderson
AnMed Health Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: John Eric Doster
Phone: 864-512-1000
Boiling Springs
Prisma Health Cancer Institute - Spartanburg
Status: CLOSED_TO_ACCRUAL
Contact: Jeffrey Kent Giguere
Phone: 864-241-6251
Greenville
Prisma Health Cancer Institute - Eastside
Status: CLOSED_TO_ACCRUAL
Contact: Jeffrey Kent Giguere
Phone: 864-241-6251
Prisma Health Cancer Institute - Faris
Status: CLOSED_TO_ACCRUAL
Contact: Jeffrey Kent Giguere
Phone: 864-241-6251
Saint Francis Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Robert D. Siegel
Phone: 864-255-1713
Greenwood
Self Regional Healthcare
Status: CLOSED_TO_ACCRUAL
Contact: Carolyn Dolores Britten
Phone: 843-792-9321
Greer
Gibbs Cancer Center-Pelham
Status: CLOSED_TO_ACCRUAL
Contact: Patricia C. Griffin
Phone: 800-486-5941
Prisma Health Cancer Institute - Greer
Status: CLOSED_TO_ACCRUAL
Contact: Jeffrey Kent Giguere
Phone: 864-241-6251
Seneca
Prisma Health Cancer Institute - Seneca
Status: CLOSED_TO_ACCRUAL
Contact: Jeffrey Kent Giguere
Phone: 864-241-6251
Spartanburg
Spartanburg Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Patricia C. Griffin
Phone: 800-486-5941

South Dakota

Sioux Falls
Sanford USD Medical Center - Sioux Falls
Status: CLOSED_TO_ACCRUAL
Contact: Preston D. Steen
Phone: 701-234-6161

Texas

Conroe
MD Anderson in The Woodlands
Status: CLOSED_TO_ACCRUAL
Contact: Heath D. Skinner
Phone: 713-792-3245
Galveston
University of Texas Medical Branch
Status: CLOSED_TO_ACCRUAL
Contact: Todd Allen Swanson
Phone: 409-772-1950
Houston
Houston Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Eric Howard Bernicker
Phone: 713-790-2700
M D Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Heath D. Skinner
Phone: 713-792-3245
MD Anderson West Houston
Status: CLOSED_TO_ACCRUAL
Contact: Heath D. Skinner
Phone: 713-792-3245
League City
MD Anderson League City
Status: CLOSED_TO_ACCRUAL
Contact: Heath D. Skinner
Phone: 713-792-3245
UTMB Cancer Center at Victory Lakes
Status: CLOSED_TO_ACCRUAL
Contact: Todd Allen Swanson
Phone: 409-772-1950
Sugar Land
MD Anderson in Sugar Land
Status: CLOSED_TO_ACCRUAL
Contact: Heath D. Skinner
Phone: 713-792-3245

Utah

Murray
Intermountain Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: George M. Cannon
Phone: 801-507-3950

Vermont

Berlin
Central Vermont Medical Center / National Life Cancer Treatment
Status: CLOSED_TO_ACCRUAL
Contact: Christopher J. Anker
Phone: 802-656-4101
Burlington
University of Vermont Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Christopher J. Anker
Phone: 802-656-4101
Saint Johnsbury
Norris Cotton Cancer Center-North
Status: CLOSED_TO_ACCRUAL
Contact: Alan Charles Hartford
Phone: 800-639-6918

Virginia

Fishersville
Augusta Health Center for Cancer and Blood Disorders
Status: CLOSED_TO_ACCRUAL
Contact: Robert M. Kyler
Phone: 540-245-7106

Washington

Bremerton
Harrison Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
Longview
PeaceHealth Saint John Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Paul G. Montgomery
Phone: 208-381-3376
Vancouver
PeaceHealth Southwest Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Paul G. Montgomery
Phone: 208-381-3376

West Virginia

Wheeling
Wheeling Hospital / Schiffler Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Jondavid Pollock
Phone: 304-243-6442

Wisconsin

Grafton
Aurora Cancer Care-Grafton
Status: CLOSED_TO_ACCRUAL
Contact: Rubina Qamar
Phone: 888-709-2080
Green Bay
Aurora BayCare Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Rubina Qamar
Phone: 888-709-2080
Kenosha
Aurora Cancer Care-Kenosha South
Status: CLOSED_TO_ACCRUAL
Contact: Rubina Qamar
Phone: 888-709-2080
Marinette
Bay Area Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Rubina Qamar
Phone: 888-709-2080
Marshfield
Marshfield Medical Center-Marshfield
Status: CLOSED_TO_ACCRUAL
Contact: Bilal H. Naqvi
Phone: 800-839-3956
Menomonee Falls
Froedtert Menomonee Falls Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Elizabeth M. Gore
Phone: 414-805-4380
Mequon
Ascension Columbia Saint Mary's Hospital Ozaukee
Status: CLOSED_TO_ACCRUAL
Contact: Craig Allan Schulz
Phone: 414-326-2675
Milwaukee
Ascension Columbia Saint Mary's Hospital - Milwaukee
Status: CLOSED_TO_ACCRUAL
Contact: Craig Allan Schulz
Phone: 414-326-2675
Aurora Saint Luke's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Rubina Qamar
Phone: 888-709-2080
Medical College of Wisconsin
Status: CLOSED_TO_ACCRUAL
Contact: Elizabeth M. Gore
Phone: 414-805-4380
Zablocki Veterans Administration Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Elizabeth M. Gore
Phone: 414-805-4380
Minocqua
Marshfield Clinic-Minocqua Center
Status: CLOSED_TO_ACCRUAL
Contact: Bilal H. Naqvi
Phone: 800-839-3956
New Richmond
Cancer Center of Western Wisconsin
Status: CLOSED_TO_ACCRUAL
Contact: Paul W. Sperduto
Phone: 952-993-1517
Rice Lake
Marshfield Medical Center-Rice Lake
Status: CLOSED_TO_ACCRUAL
Contact: Bilal H. Naqvi
Phone: 800-839-3956
Stevens Point
Ascension Saint Michael's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Bilal H. Naqvi
Phone: 800-839-3956
Summit
Aurora Medical Center in Summit
Status: CLOSED_TO_ACCRUAL
Contact: Rubina Qamar
Phone: 888-709-2080
Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Status: CLOSED_TO_ACCRUAL
Contact: Rubina Qamar
Phone: 888-709-2080
West Allis
Aurora West Allis Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Rubina Qamar
Phone: 888-709-2080
West Bend
Froedtert West Bend Hospital / Kraemer Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Elizabeth M. Gore
Phone: 414-805-4380
Weston
Diagnostic and Treatment Center
Status: CLOSED_TO_ACCRUAL
Contact: Bilal H. Naqvi
Phone: 800-839-3956
Wisconsin Rapids
Aspirus Cancer Care - Wisconsin Rapids
Status: CLOSED_TO_ACCRUAL
Contact: Anna Kathryn Olson
Phone: 877-405-6866

Quebec

Montreal
Jewish General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Khalil Sultanem
Phone: 514-340-8222ext8248

Saskatchewan

Regina
Allan Blair Cancer Centre
Status: CLOSED_TO_ACCRUAL
Contact: Michelle Joanne Ferguson
Phone: 306-766-2213
Saskatoon
Saskatoon Cancer Centre
Status: CLOSED_TO_ACCRUAL
Contact: Bryan Laurent Brunet
Phone: 306-655-2914

Israel

Tel Hashomer
Chaim Sheba Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Tatiana Rabin
Phone: 972 3 530-5943

PRIMARY OBJECTIVES:

I. To determine whether MET (metformin hydrochloride) added to chemoradiotherapy can improve progression-free survival (PFS) in patients with locally advanced non-small cell lung cancer (NSCLC).

SECONDARY OBJECTIVES:

I. Determine the effects of MET on overall survival (OS), time to local-regional progression (LRP), and time to distant metastasis (DM).

II. Evaluate the effect of MET on chemoradiotherapy toxicity (Common Terminology Criteria for Adverse Events, version 4 [CTCAE, v. 4]) within 1 year of completion of all treatment.

III. Collect biospecimens to develop biomarkers of MET activity.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive paclitaxel intravenously (IV) over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36 and undergo radiation therapy (3-dimensional conformal radiation therapy [3D-CRT] or intensity modulated radiation therapy [IMRT]) once daily (QD) 5 days a week for 6 weeks. Beginning 28-42 days after completion of radiation therapy, patients receive consolidation chemotherapy comprising paclitaxel IV and carboplatin IV on days 1 and 22. Treatment with consolidation chemotherapy repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive metformin hydrochloride orally (PO) twice daily (BID) or thrice daily (TID) for 14 days. Beginning on day 15, patients undergo radiation therapy and receive paclitaxel and carboplatin as in Arm I, and receive metformin hydrochloride BID or TID for 6 weeks. Beginning 28-42 days after completion of radiation therapy, patients receive consolidation chemotherapy as in Arm I and metformin hydrochloride PO BID or TID for 10 weeks.

After completion of study treatment, patients are followed up at 4-6 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
NRG Oncology

Principal Investigator
Theodoros Tsakiridis

  • Primary ID NRG-LU001
  • Secondary IDs NCI-2014-01071, PNRG-LU001_A01PAMDREVW01
  • Clinicaltrials.gov ID NCT02186847