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



Status:Active, not recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/22/2019
Start Date:August 2014
End Date:April 16, 2024

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Randomized Phase II Trial of Concurrent Chemoradiotherapy +/- Metformin HCL in Locally Advanced NSCLC

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.

PRIMARY OBJECTIVES:

I. To determine whether metformin hydrochloride (MET) 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.

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

- Platelets >= 100,000 cells/mm^3

- Hemoglobin >= 8.0 g/dl (note: the use of transfusion or other intervention to achieve
hemoglobin [Hgb] >= 8.0 g/dl is acceptable)

- Serum creatinine within normal institutional limits or creatinine clearance must be at
least 60 ml/min

- Total bilirubin =< 1.5 x upper limit of normal (ULN) for the institution

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN for
the institution

- Alkaline phosphatase =< 2.5 x ULN for the institution

- 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
We found this trial at
221
sites
211 Saint Francis Drive
Cape Girardeau, Missouri 63703
573-331-3000
Principal Investigator: James L. Wade
Phone: 217-876-4740
Saint Francis Medical Center Saint Francis Medical Center is a 282-bed facility serving more than...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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Bremerton, Washington 98310
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
Principal Investigator: Todd A. Swanson
Phone: 409-772-1950
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
Principal Investigator: Sunil Nagpal
Phone: 269-373-7458
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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2226 Liliha Street
'Aiea, Hawaii 96701
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Albuquerque, New Mexico 87109
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2000 E Greenville St
Anderson, South Carolina 29621
(864) 512-4640
Principal Investigator: John E. Doster
Phone: 864-512-1000
AnMedical Health Cancer Center Cancer is the general term for a group of more than...
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Arlington Heights, Illinois 60005
Principal Investigator: Stephen S. Nigh
Phone: 847-618-4968
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1968 Peachtree Rd NW
Atlanta, Georgia 30309
(404) 605-5000
Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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Baton Rouge, Louisiana 70805
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Baton Rouge, Louisiana 70809
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Baton Rouge, Louisiana 70809
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4950 Essen Lane
Baton Rouge, Louisiana 70809
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Bel Air, Maryland 21014
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1300 Anne Street NW
Bemidji, Minnesota 56601
(218) 751-5430
Principal Investigator: Preston D. Steen
Phone: 701-234-6161
Sanford Clinic North-Bemidgi Sanford Health is a voluntary, not-for-profit health care organization. Through its entities,...
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Billings, Montana 59101
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300 N. Seventh St.
Bismarck, North Dakota 58501
(701) 323-6000
Principal Investigator: Preston D. Steen
Phone: 701-234-6161
Sanford Bismarck Medical Center Whether your stay in our hospital is one day for same...
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963 East 7th Street
Bloomington, Indiana 47402
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Boise, Idaho 83706
Principal Investigator: Philip J. Stella
Phone: 734-712-4673
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Boston, Massachusetts 02118
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263 7th Avenue
Brooklyn, New York 11215
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Burlington, Vermont 05405
Principal Investigator: Christopher J. Anker
Phone: 802-656-4101
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Canton, Ohio 44708
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2600 Sixth St. SW
Canton, Ohio 44710
330.363.4908
Aultman Health Foundation The Aultman Foundation will raise and administer funds in order to support...
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789 Mt Auburn Rd
Cape Girardeau, Missouri 63703
(573) 519-4725
Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
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Castro Valley, California 94546
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Cedar Rapids, Iowa 52403
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Chardon, Ohio 44024
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1969 W Ogden Ave
Chicago, Illinois 60612
(312) 864-6000
John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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272 Hospital Rd
Chillicothe, Ohio 45601
740-779-7500
Principal Investigator: John P. Kuebler
Phone: 614-488-2745
Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
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18101 Lorain Avenue
Cleveland, Ohio 44111
216.476.7000
Principal Investigator: Gregory M. M. Videtic
Phone: 866-223-8100
Cleveland Clinic Cancer Center at Fairview Hospital Fairview Hospital is a 488-bed hospital located at...
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Gregory M. M. Videtic
Phone: 866-223-8100
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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6001 E Woodmen Rd
Colorado Springs, Colorado 80923
(719) 776-5000
Penrose-Saint Francis Healthcare Founded by the Sisters of St. Francis and the Sisters of Charity,...
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1400 East Boulder Street
Colorado Springs, Colorado 80909
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1831 Fifth Avenue
Columbus, Georgia 31904
(706) 320-8700
John B. Amos Cancer Center The John B. Amos Cancer Center located in Columbus, Georgia,...
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Columbus, Ohio 43210
Principal Investigator: Jose G. Bazan
Phone: 800-293-5066
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3100 Plaza Properties Blvd
Columbus, Ohio 43219
(614) 383-6000
Principal Investigator: John P. Kuebler
Phone: 614-488-2745
The Mark H. Zangmeister Center At The Zangmeister Center, we appreciate that our patients have...
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Columbus, Ohio 43222
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
(763) 236-6000
Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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2222 Philadelphia Dr
Dayton, Ohio 45406
(937) 734-2612
Good Samaritan Hospital - Dayton Good Samaritan Hospital (GSH) is passionate about providing the most...
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Decatur, Georgia 30033
Principal Investigator: Jayanthi Srinivasiah
Phone: 404-501-3279
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
Principal Investigator: James L. Wade
Phone: 217-876-4740
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Dover, New Hampshire 03820
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Duluth, Minnesota 55805
Principal Investigator: Basem S. Goueli
Phone: 888-823-5923
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Dunmore, Pennsylvania 18512
Principal Investigator: Bo Lu
Phone: 215-955-6084
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6401 France Ave S
Edina, Minnesota 55435
(952) 924-5000
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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913 North Dixie Highway
Elizabethtown, Kentucky 42701
Principal Investigator: Amy Schell
Phone: 859-260-6425
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Elyria, Ohio 44035
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501 E. Hampden Ave.
Englewood, Colorado 80113
303-788-5000
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Erie, Pennsylvania 16505
Principal Investigator: Jan M. Rothman
Phone: 814-838-0448
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820 4th St N
Fargo, North Dakota 58102
(701) 234-6161
Principal Investigator: Preston D. Steen
Phone: 701-234-6161
Roger Maris Cancer Center Sanford Health is an integrated health system headquartered in the Dakotas...
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Fishersville, Virginia 22939
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Flint, Michigan 48532
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2200 Randallia Drive
Fort Wayne, Indiana 46805
Principal Investigator: Brian K. Chang
Phone: 260-373-8888
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Fort Wayne, Indiana 46804
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Gastonia, North Carolina 28054
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Gastonia, North Carolina 28054
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Glen Burnie, Maryland 21061
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Grafton, Wisconsin 53024
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Grand Island, Nebraska 68803
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100 Michigan St NE
Grand Rapids, Michigan 49503
(616) 391-1774
Principal Investigator: Gilbert D. Padula
Phone: 616-685-5225
Spectrum Health at Butterworth Campus Butterworth Hospital is one of four facilities that make up...
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Grand Rapids, Michigan 49503
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1801 16th St
Greeley, Colorado 80631
(970) 352-4121
North Colorado Medical Center NCMC is a fully accredited, private, non-profit facility licensed to operate...
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2845 Greenbrier Rd
Green Bay, Wisconsin 54311
(920) 288-8000
Aurora BayCare Medical Center Aurora BayCare Medical Center is a 167-bed, full-service hospital serving the...
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Greenville, South Carolina 29605
Principal Investigator: Jeffrey K. Giguere
Phone: 864-241-6251
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Greenville, South Carolina 29615
Principal Investigator: Jeffrey K. Giguere
Phone: 864-241-6251
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Greenville, South Carolina 29607
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Greenwood, South Carolina 29646
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Greer, South Carolina 29650
Principal Investigator: Jeffrey K. Giguere
Phone: 864-241-6251
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Greer, South Carolina 29651
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1301 Punchbowl St
Honolulu, Hawaii 96813
(808) 538-9011
Principal Investigator: Kenneth N. Sumida
Phone: 808-586-2979
Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
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Honolulu, Hawaii 96817
Principal Investigator: Kenneth N. Sumida
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Houston, Texas 77030
Principal Investigator: Eric H. Bernicker
Phone: 713-790-2700
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Houston, Texas 77030
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Independence, Ohio 44131
Principal Investigator: Gregory M. M. Videtic
Phone: 866-223-8100
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8111 South Emerson Avenue
Indianapolis, Indiana 46237
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Kansas City, Kansas 66160
Principal Investigator: Parvesh Kumar
Phone: 913-945-7552
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Kansas City, Missouri 64131
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Kansas City, Missouri 64154
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2800 Clay Edwards Dr
Kansas City, Missouri 64116
(816) 691-2000
North Kansas City Hospital Generations of Northlanders have considered North Kansas City Hospital as their...
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Kearney, Nebraska 68847
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