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A Randomized Phase III Trial of Carboplatin, Paclitaxel and Thoracic Radiotherapy, With or Without Thalidomide, in Patients With Stage III Non-Small Cell Lung Cancer (NSCLC)


Phase 3
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

A Randomized Phase III Trial of Carboplatin, Paclitaxel and Thoracic Radiotherapy, With or Without Thalidomide, in Patients With Stage III Non-Small Cell Lung Cancer (NSCLC)


OBJECTIVES:

I. Compare the survival and time to progression of patients with stage IIIA or IIIB
non-small cell lung cancer when treated with carboplatin, paclitaxel, and chemoradiotherapy
with or without thalidomide.

II. Evaluate the toxicity of the thalidomide-containing regimen and compare response rates
of the two groups.

III. Determine whether the inactivation of p16, Death-associated protein kinase
(DAP-kinase), O6-methylguanine-DNA methyltransferase (MGMT) gene, or tissue-inhibitor of
metalloproteinase 3 (TIMP-3) genes can be used to predict survival in these patients treated
with this regimen.

IV. Determine whether the detection of a methylation biomarker in serum can be used to
predict survival in these patients treated with this regimen.

OUTLINE: This is a randomized study. Patients are stratified according to disease histology
(squamous vs nonsquamous), performance status (0 vs 1), disease stage (IIIA vs IIIB), and
time of randomization (before addition of chemoradiotherapy vs after). Patients are
randomized to one of two treatment arms.

ARM A: Patients receive paclitaxel intravenously (IV) over 3 hours immediately followed by
carboplatin IV over 15-30 minutes on days 1 and 22. Treatment continues every 22 days in the
absence of unacceptable toxicity or disease progression.

ARM B: Patients receive paclitaxel and carboplatin as in arm A. Patients also receive oral
thalidomide and oral low-dose aspirin daily beginning on day 1 for up to 24 months in the
absence of disease progression.

Beginning between days 43-50, patients in both arms with stable or responding disease
receive chemoradiotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 15-30
minutes once weekly for 6 weeks and radiotherapy (RT) 5 days a week for 6 weeks. Arm B
patients continue oral thalidomide.

Patients are followed every 2 months for 2 years and then every 6 months for 3 years.


Inclusion Criteria:



- Histologically confirmed newly diagnosed non-small cell bronchogenic carcinoma

- Squamous cell

- Adenocarcinoma

- Large cell undifferentiated

- Bronchoalveolar

- Non-small cell carcinoma not otherwise stated

- Unresectable stage IIIA

- Mediastinal lymph node enlargement of at least 1 cm but less than 2 cm on
computed tomography (CT) scans must have mediastinotomy or thoracoscopy to rule
out resectability

OR

- Stage IIIB disease without significant pleural effusion

- Seen on CT scan only (not seen on chest x-ray) or does not reaccumulate after 1
thoracentesis and is cytologically negative

- Metastases to contralateral, mediastinal, or supraclavicular nodes allowed

- Bidimensionally measurable or evaluable disease

- 18 and over

- ECOG performance status 0-1

- Adequate hematopoietic, hepatic, and renal function obtained <=4 weeks prior to
registration:

- Platelet count at least 100,000/mm^3

- White Blood Cell (WBC) count at least 4,000/mm^3 OR absolute neutrophil count at
least 2,000/mm^3

- Bilirubin normal

- Serum glutamic oxaloacetic transaminase (SGOT) no greater than 2.5 times upper
limit of normal

- Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min

- Fertile patients must use 2 methods of effective contraception for 4 weeks prior to,
during, and for 4 weeks after study therapy

- Concurrent filgrastim (G-CSF) allowed for persistent neutropenia

Exclusion Criteria:

- Positive pregnancy test,pregnant or nursing

- Uncontrolled high blood pressure, unstable angina, congestive heart failure, or
myocardial infarction within the prior year

- Serious cardiac arrhythmias requiring medication

- Prior radiotherapy to only area of measurable or active tumor

- Less than 5 years since prior chemotherapy

- Other active malignancies

- Serious uncontrolled active infection

- Evidence of greater than grade 1 neuropathy by history or physical examination

- History of seizure disorders

- Contraindication to daily low-dose (81 mg/day) aspirin

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival Time

Outcome Description:

Survival time is defined as time from study entry to death from any cause

Outcome Time Frame:

every other month until 24 months from study entry, then every 3 months for year 3, every 4 months for year 4 and every 6 months for year 5

Safety Issue:

No

Principal Investigator

Joan H. Schiller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02943

NCT ID:

NCT00004859

Start Date:

January 2000

Completion Date:

May 2011

Related Keywords:

  • Lung Cancer
  • squamous cell lung cancer
  • large cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • adenocarcinoma of the lung
  • adenosquamous cell lung cancer
  • bronchoalveolar cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Akron City HospitalAkron, Ohio  44304
Hurley Medical CenterFlint, Michigan  48503
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
Aurora Presbyterian HospitalAurora, Colorado  80012
Boulder Community HospitalBoulder, Colorado  80301-9019
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical CenterGrand Junction, Colorado  81502
Sky Ridge Medical CenterLone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United HospitalLongmont, Colorado  80502
North Suburban Medical CenterThornton, Colorado  80229
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Tufts-NEMC Cancer CenterBoston, Massachusetts  02111
Baystate Regional Cancer Program at D'Amour Center for Cancer CareSpringfield, Massachusetts  01199
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Foote HospitalJackson, Michigan  49201
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
Seton Cancer Institute - SaginawSaginaw, Michigan  48601
St. John Macomb HospitalWarren, Michigan  48093
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
CCOP - DuluthDuluth, Minnesota  55805
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
St. Rita's Medical CenterLima, Ohio  45801
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Dean Medical Center - MadisonMadison, Wisconsin  53717
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Mercy Hospital Cancer Center - ScrantonScranton, Pennsylvania  18501
Grand View HospitalSellersville, Pennsylvania  18960
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
CCOP - GreenvilleGreenville, South Carolina  29615
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
MetroHealth's Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44106
CCOP - Scott and White HospitalTemple, Texas  76508
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Medical Center of Central GeorgiaMacon, Georgia  31201
St. Vincent Mercy Medical CenterToledo, Ohio  43608
CCOP - Colorado Cancer Research Program, IncorporatedDenver, Colorado  80224
Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15236
Great Falls ClinicGreat Falls, Montana  59405
Overlook HospitalSummit, New Jersey  07902-0220
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Carol G. Simon Cancer Center at Morristown Memorial HospitalMorristown, New Jersey  07962
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
Cancer Institute of New Jersey at HamiltonHamilton, New Jersey  08690
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Toledo HospitalToledo, Ohio  43606
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston DivisionCharleston, West Virginia  25302
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Aultman Hospital Cancer Center at Aultman Health FoundationCanton, Ohio  44710-1799
St. Mary's - Duluth Clinic Cancer CenterDuluth, Minnesota  55805
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
Hunterdon Regional Cancer Center at Hunterdon Medical CenterFlemington, New Jersey  08822
Warren HospitalPhillipsburg, New Jersey  08865
Our Lady of Mercy Medical Center Comprehensive Cancer CenterBronx, New York  10466
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
Lewistown HospitalLewistown, Pennsylvania  17044
Mount Nittany Medical CenterState College, Pennsylvania  16803
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa  52722
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
Big Sky OncologyGreat Falls, Montana  59405
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grant Riverside Cancer ServicesColumbus, Ohio  43215
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Lakeland Cancer Care Center at Lakeland Hospital - St. JosephSaint Joseph, Michigan  49085
MBCCOP - Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3730
Swedish-American Regional Cancer CenterRockford, Illinois  61104-2315
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Elkhart General HospitalElkhart, Indiana  46515
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
Joan Karnell Cancer Center at Pennsylvania HospitalPhiladelphia, Pennsylvania  19107
Jennersville Regional HospitalWest Grove, Pennsylvania  19390-9499
Memorial Medical Center Cancer ServicesModesto, California  95355
Salinas Valley Memorial HospitalSalinas, California  93901
Memorial HospitalColorado Springs, Colorado  80909
St. Mary-Corwin Regional Medical CenterPueblo, Colorado  81004
Swedish Covenant HospitalChicago, Illinois  60625
Mercy Hospital and Medical CenterChicago, Illinois  60616
Midwest Center for Hematology/OncologyJoliet, Illinois  60432
Trinity Medical Center - EastMoline, Illinois  61265
Hematology/Oncology of the North Shore at Gross Point Medical CenterSkokie, Illinois  60076
Howard Community Hospital at Howard Regional Health SystemKokomo, Indiana  46904
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Reid Hospital & Health Care Services, IncorporatedRichmond, Indiana  47374
St. Luke's HospitalCedar Rapids, Iowa  52402
Mercy Regional Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
Genesis Regional Cancer Center at Genesis Medical CenterDavenport, Iowa  52803
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
St. Joseph Mercy Cancer Center at St. Joseph Mercy HospitalAnn Arbor, Michigan  48106-0995
Green Bay Oncology, Limited - Iron MountainIron Mountain, Michigan  49801
Mercy Memorial Hospital SystemMonroe, Michigan  48162
Alexandria, Minnesota  56308
Virginia Piper Cancer Institute at Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Medical CenterRobbinsdale, Minnesota  55422-2900
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Park Nicollet Health ServicesSt. Louis Park, Minnesota  55416
Immanuel Medical CenterOmaha, Nebraska  68122
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Mountainside Hospital Cancer CenterMontclair, New Jersey  07042
Booker Cancer Center at Riverview Medical CenterRed Bank, New Jersey  07701
Wilson Medical CenterWilson, North Carolina  27893-3428
Cancer Care Center at Medcenter One HospitalBismarck, North Dakota  58501
Bismarck Cancer CenterBismarck, North Dakota  58501
St. Alexius Medical CenterBismarck, North Dakota  58502
Mid Dakota Clinic, P. C.Bismarck, North Dakota  58501
Samaritan North Cancer Care CenterDayton, Ohio  45415
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Fremont Memorial HospitalFremont, Ohio  43420
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Lima Memorial HospitalLima, Ohio  45804
St. Luke's HospitalMaumee, Ohio  43537
Northwest Ohio Oncology CenterMaumee, Ohio  43537
St. Charles Mercy HospitalOregon, Ohio  43616
Firelands Regional Medical CenterSandusky, Ohio  44870
Mercy Medical CenterSpringfield, Ohio  45504
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Fulton County Health CenterWauseon, Ohio  43567
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Hematology and Oncology AssociatesScranton, Pennsylvania  18510
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical CenterKingsport, Tennessee  37662
Danville Regional Medical CenterDanville, Virginia  24541
Southwest Virginia Regional Cancer CenterNorton, Virginia  24273
Green Bay Oncology, Limited at St. Vincent HospitalGreen Bay, Wisconsin  54301-3526
DeCesaris Cancer Institute at Anne Arundel Medical CenterAnnapolis, Maryland  21401
William W. Backus HospitalNorwich, Connecticut  06360
Morton Hospital & Medical CenterTaunton, Massachusetts  02780
Miller-Dwan Medical CenterDuluth, Minnesota  55805
Lancaster General HospitalLancaster, Pennsylvania  17604-3555
Pottstown Memorial Regional Cancer CenterPottstown, Pennsylvania  19464
Hembree Mercy Cancer Center at St. Edward Mercy Medical CenterFt. Smith, Arkansas  72903
Pearlman Comprehensive Cancer Center at South Georgia Medical CenterValdosta, Georgia  31603
Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins CountyMadisonville, Kentucky  42431
Saint Francis Cancer CenterShakopee, Minnesota  55379
St. Joseph's HospitalSt Paul, Minnesota  55102
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Allegheny Cancer Center at Allegheny General HospitalPittsburgh, Pennsylvania  15212
All Saints Cancer Center at All Saints HealthcareRacine, Wisconsin  53405
Praxair Cancer Center at Danbury HospitalDanbury, Connecticut  06810
Haematology-Oncology Associates of Ohio and Michigan, PCLambertville, Michigan  48144
Alegant Health Cancer Center at Bergan Mercy Medical CenterOmaha, Nebraska  68124
Flower Hospital Cancer CenterSylvania, Ohio  43560
Stanford Comprehensive Cancer Center at Stanford University Medical CenterStanford, California  94305
Easton Regional Cancer Center at Easton HospitalEaston, Pennsylvania  18042
MedCentral - Mansfield HospitalMansfield, Ohio  44903
MBCCOP - Meharry Medical College - NashvilleNashville, Tennessee  37208-3599
University of Virginia Cancer Center at UV Health SystemCharlottesville, Virginia  22908
Great Falls, Montana  59405
Sletten Regional Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
PinnacleHealth Regional Cancer Center at Polyclinic HospitalHarrisburg, Pennsylvania  17105
Cancer Care Institute of Carolina at Aiken Regional Medical CentersAiken, South Carolina  29801
Lipson Cancer and Blood Center at Rochester General HospitalRochester, New York  14621
Halifax Medical Center - Daytona BeachDaytona Beach, Florida  32115
Veterans Affairs Medical Center - AugustaAugusta, Georgia  30904
Newton-Wellesley HospitalNewton, Massachusetts  02462
Woodwinds Health CampusWoodbury, Minnesota  55125
Shore Memorial Hospital - Somers PointSomers Point, New Jersey  08244
Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer CenterDubois, Pennsylvania  15801
Cancer Center at Phoenixville HospitalPhoenixville, Pennsylvania  19460
Marshall University Medical CenterHuntington, West Virginia  25701