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Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Patients With Stage III Non-small Cell Lung Cancer

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: NCT00004859
Recruitment Status : Terminated (Trial was stopped early for futility)
First Posted : January 27, 2003
Results First Posted : March 22, 2012
Last Update Posted : June 2, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This randomized phase III trial is studying carboplatin, paclitaxel, radiation therapy, and thalidomide to see how well they work compared to carboplatin, paclitaxel, and radiation therapy alone in treating patients with newly diagnosed stage III non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of non-small cell lung cancer by stopping blood flow to the tumor. It is not yet known if combination chemotherapy plus radiation therapy is more effective with or without thalidomide.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: carboplatin Drug: paclitaxel Drug: thalidomide Radiation: radiation therapy Phase 3

Detailed Description:

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 589 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : January 2000
Actual Primary Completion Date : December 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Active Comparator: Arm A (Paclitaxel + Carboplatin + RT)

Induction chemotherapy dosing: Paclitaxel, 225 mg/m² (3 hour infusion) Day 1. Carboplatin, area under the plasma drug concentration versus time curve (AUC) =6.0, 15-30 min IV infusion immediately following paclitaxel, Day 1

Concurrent chemotherapy / radiotherapy dosing: Paclitaxel, 45 mg/m2, administered weekly during radiotherapy over one hour. Carboplatin, AUC=2, 15- 30 minutes IV infusion immediately following paclitaxel; administered weekly during radiotherapy

Radiation therapy started between days 43-50 from day 1 of cycle 1. The primary tumor and areas of known nodal disease received 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks to the post chemotherapy tumor volume as seen on computed tomography (CT). The initial 50 Gy was delivered to target volume (TV). The final 10 Gy was delivered to a reduced volume targeting defined by TV

Drug: carboplatin
Induction Chemotherapy dosing: AUC=6.0, 15-30 min IV infusion immediately following paclitaxel, Day 1 and Day 22. Concurrent Chemotherapy / Radiotherapy dosing, AUC=2; 15- 30 minutes IV infusion immediately following paclitaxel; administered weekly during radiotherapy
Other Names:
  • CBDCA
  • Paraplatin
  • JM-8
  • NSC 241240

Drug: paclitaxel
Induction chemotherapy dosing: 225 mg/m² (3 hour infusion) Day 1 and Day 22. Concurrent Chemotherapy / Radiotherapy dosing: 45 mg/m2; administered weekly during radiotherapy over one hour
Other Names:
  • Taxol
  • NSC 125973

Radiation: radiation therapy
Radiation therapy started between days 43-50 from day 1 of cycle 1. The primary tumor and areas of known nodal disease received 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks to the post chemotherapy tumor volume as seen on computed tomography (CT). The initial 50 Gy was delivered to target volume (TV). The final 10 Gy was delivered to a reduced volume targeting defined by TV
Other Name: thoracic radiotherapy

Experimental: Arm B (Paclitaxel + Carboplatin + RT+ Thalidomide)

paclitaxel, carboplatin, and radiotherapy are same as those in Arm A.

thalidomide: Induction chemotherapy dosing, oral daily, starting Day 1 for 24 months or until disease progression. Concurrent chemotherapy / radiotherapy dosing, oral daily, begin with 200 mg thalidomide as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg.

Drug: carboplatin
Induction Chemotherapy dosing: AUC=6.0, 15-30 min IV infusion immediately following paclitaxel, Day 1 and Day 22. Concurrent Chemotherapy / Radiotherapy dosing, AUC=2; 15- 30 minutes IV infusion immediately following paclitaxel; administered weekly during radiotherapy
Other Names:
  • CBDCA
  • Paraplatin
  • JM-8
  • NSC 241240

Drug: paclitaxel
Induction chemotherapy dosing: 225 mg/m² (3 hour infusion) Day 1 and Day 22. Concurrent Chemotherapy / Radiotherapy dosing: 45 mg/m2; administered weekly during radiotherapy over one hour
Other Names:
  • Taxol
  • NSC 125973

Drug: thalidomide
Induction Chemotherapy dosing: oral daily, starting Day 1 for 24 months or until disease progression. Concurrent Chemotherapy / Radiotherapy dosing: oral daily, begin with 200 mg thalidomide as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg.
Other Names:
  • (d,1)-N phthalidoglutarimide
  • Thalomid
  • NSC #66847
  • IND # 48832

Radiation: radiation therapy
Radiation therapy started between days 43-50 from day 1 of cycle 1. The primary tumor and areas of known nodal disease received 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks to the post chemotherapy tumor volume as seen on computed tomography (CT). The initial 50 Gy was delivered to target volume (TV). The final 10 Gy was delivered to a reduced volume targeting defined by TV
Other Name: thoracic radiotherapy




Primary Outcome Measures :
  1. Overall Survival Time [ 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 ]
    Survival time is defined as time from study entry to death from any cause


Secondary Outcome Measures :
  1. Time to Disease Progression [ Time Frame: every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year ]
    Time to disease progression is defined as the time from randomization to documented disease progression or to death without progression. Patients without documented progression or death reported were censored at the time of the last documented disease evaluation. Progression is defined, using the Response Evaluation Criteria In Solid Tumors (RECIST), as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.

  2. Response Rate at Best Response to Treatment [ Time Frame: every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year ]
    Proportion of patients with complete or partial response using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.0. Complete response is defined as the complete disappearance of all clinically detectable malignant disease for at least 4 weeks. Partial response is defined as greater than or equal to 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease.



Information from the National Library of Medicine

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

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

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): NCT00004859


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Locations
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United States, Arkansas
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Ft. Smith, Arkansas, United States, 72903
United States, California
Memorial Medical Center Cancer Services
Modesto, California, United States, 95355
Salinas Valley Memorial Hospital
Salinas, California, United States, 93901
Stanford Comprehensive Cancer Center at Stanford University Medical Center
Stanford, California, United States, 94305
United States, Colorado
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
Memorial Hospital
Colorado Springs, Colorado, United States, 80909
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
St. Joseph Hospital
Denver, Colorado, United States, 80218
Rose Medical Center
Denver, Colorado, United States, 80220
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States, 80224-2522
Swedish Medical Center
Englewood, Colorado, United States, 80110
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States, 80502
St. Mary-Corwin Regional Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thornton, Colorado, United States, 80229
United States, Connecticut
Praxair Cancer Center at Danbury Hospital
Danbury, Connecticut, United States, 06810
William W. Backus Hospital
Norwich, Connecticut, United States, 06360
United States, Florida
Halifax Medical Center - Daytona Beach
Daytona Beach, Florida, United States, 32115
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
United States, Georgia
Veterans Affairs Medical Center - Augusta
Augusta, Georgia, United States, 30904
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States, 30033
Medical Center of Central Georgia
Macon, Georgia, United States, 31208
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
Valdosta, Georgia, United States, 31603
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Mercy Hospital and Medical Center
Chicago, Illinois, United States, 60616
Swedish Covenant Hospital
Chicago, Illinois, United States, 60625
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States, 60521
Midwest Center for Hematology/Oncology
Joliet, Illinois, United States, 60432
Trinity Medical Center - East
Moline, Illinois, United States, 61265
Swedish-American Regional Cancer Center
Rockford, Illinois, United States, 61104-2315
Hematology/Oncology of the North Shore at Gross Point Medical Center
Skokie, Illinois, United States, 60076
United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Howard Community Hospital at Howard Regional Health System
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Reid Hospital & Health Care Services, Incorporated
Richmond, Indiana, United States, 47374
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
United States, Iowa
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States, 52722
St. Luke's Hospital
Cedar Rapids, Iowa, United States, 52402
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States, 52403
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, United States, 52803
Mercy Capitol Hospital
Des Moines, Iowa, United States, 50307
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316-2301
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines, Iowa, United States, 50266
United States, Kentucky
Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
Madisonville, Kentucky, United States, 42431
United States, Maryland
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
United States, Massachusetts
Tufts-NEMC Cancer Center
Boston, Massachusetts, United States, 02111
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield, Massachusetts, United States, 01199
Morton Hospital & Medical Center
Taunton, Massachusetts, United States, 02780
United States, Michigan
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Hurley Medical Center
Flint, Michigan, United States, 48503
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Green Bay Oncology, Limited - Iron Mountain
Iron Mountain, Michigan, United States, 49801
Foote Hospital
Jackson, Michigan, United States, 49201
Borgess Medical Center
Kalamazooaa, Michigan, United States, 49001
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, United States, 48144
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48909
Mercy Memorial Hospital System
Monroe, Michigan, United States, 48162
Seton Cancer Institute - Saginaw
Saginaw, Michigan, United States, 48601
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
St. Joseph, Michigan, United States, 49085
St. John Macomb Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Miller-Dwan Medical Center
Duluth, Minnesota, United States, 55805
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, United States, 55805
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Fergus Falls, Minnesota, United States, 56537
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Meeker County Memorial Hospital
Lichfield, Minnesota, United States, 55355
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, United States, 55422-2900
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Saint Francis Cancer Center
Shakopee, Minnesota, United States, 55379
St. Joseph's Hospital
St Paul, Minnesota, United States, 55102
CentraCare Clinic - River Campus
St. Cloud, Minnesota, United States, 56303
Park Nicollet Health Services
St. Louis Park, Minnesota, United States, 55416
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
United Hospital
St. Paul, Minnesota, United States, 55102
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Woodwinds Health Campus
Woodbury, Minnesota, United States, 55125
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
Missouri Baptist Cancer Center
St. Louis, Missouri, United States, 63131
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Deaconess Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Big Sky Oncology
Great Falls, Montana, United States, 59405
Great Falls Clinic
Great Falls, Montana, United States, 59405
Sletten Regional Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States, 59405
Great Falls, Montana, United States, 59405
United States, Nebraska
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States, 68510
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Creighton University Medical Center
Omaha, Nebraska, United States, 68131-2197
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07018-1095
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington, New Jersey, United States, 08822
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States, 08053
Mountainside Hospital Cancer Center
Montclair, New Jersey, United States, 07042
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Warren Hospital
Phillipsburg, New Jersey, United States, 08865
Booker Cancer Center at Riverview Medical Center
Red Bank, New Jersey, United States, 07701
Shore Memorial Hospital - Somers Point
Somers Point, New Jersey, United States, 08244
Overlook Hospital
Summit, New Jersey, United States, 07902
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees, New Jersey, United States, 08043
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Our Lady of Mercy Medical Center Comprehensive Cancer Center
Bronx, New York, United States, 10466
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States, 14215
Lipson Cancer and Blood Center at Rochester General Hospital
Rochester, New York, United States, 14621
CCOP - Hematology-Oncology Associates of Central New York
Syracuse, New York, United States, 13057
United States, North Carolina
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Wilson Medical Center
Wilson, North Carolina, United States, 27893-3428
United States, North Dakota
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
Cancer Care Center at Medcenter One Hospital
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic, P. C.
Bismarck, North Dakota, United States, 58501
St. Alexius Medical Center
Bismarck, North Dakota, United States, 58502
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44309-2090
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, United States, 44710-1799
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
CCOP - Columbus
Columbus, Ohio, United States, 43215
Grant Riverside Cancer Services
Columbus, Ohio, United States, 43215
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Fremont Memorial Hospital
Fremont, Ohio, United States, 43420
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
St. Rita's Medical Center
Lima, Ohio, United States, 45801
Lima Memorial Hospital
Lima, Ohio, United States, 45804
MedCentral - Mansfield Hospital
Mansfield, Ohio, United States, 44903
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
St. Luke's Hospital
Maumee, Ohio, United States, 43537
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43623
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
Firelands Regional Medical Center
Sandusky, Ohio, United States, 44870
Mercy Medical Center
Springfield, Ohio, United States, 45504
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
Toledo Hospital
Toledo, Ohio, United States, 43606
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Fulton County Health Center
Wauseon, Ohio, United States, 43567
United States, Pennsylvania
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States, 18105
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-0001
Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center
Dubois, Pennsylvania, United States, 15801
Easton Regional Cancer Center at Easton Hospital
Easton, Pennsylvania, United States, 18042
PinnacleHealth Regional Cancer Center at Polyclinic Hospital
Harrisburg, Pennsylvania, United States, 17105
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
Joan Karnell Cancer Center at Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
Cancer Center at Phoenixville Hospital
Phoenixville, Pennsylvania, United States, 19460
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
Pottstown Memorial Regional Cancer Center
Pottstown, Pennsylvania, United States, 19464
Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States, 18501
Hematology and Oncology Associates
Scranton, Pennsylvania, United States, 18510
Grand View Hospital
Sellersville, Pennsylvania, United States, 18960
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Jennersville Regional Hospital
West Grove, Pennsylvania, United States, 19390-9499
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
United States, South Carolina
Cancer Care Institute of Carolina at Aiken Regional Medical Centers
Aiken, South Carolina, United States, 29801
CCOP - Greenville
Greenville, South Carolina, United States, 29615
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States, 37662
MBCCOP - Meharry Medical College - Nashville
Nashville, Tennessee, United States, 37208-3599
United States, Texas
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Virginia
University of Virginia Cancer Center at UV Health System
Charlottesville, Virginia, United States, 22908
Danville Regional Medical Center
Danville, Virginia, United States, 24541
Southwest Virginia Regional Cancer Center
Norton, Virginia, United States, 24273
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
United States, West Virginia
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
Charleston, West Virginia, United States, 25304
Marshall University Medical Center
Huntington, West Virginia, United States, 25701
United States, Wisconsin
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Dean Medical Center - Madison
Madison, Wisconsin, United States, 53717
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
All Saints Cancer Center at All Saints Healthcare
Racine, Wisconsin, United States, 53405
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
South Africa
Pretoria Academic Hospital
Pretoria, South Africa, 0001
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Study Chair: Joan H. Schiller, MD Simmons Cancer Center

Publications of Results:
Belinsky SA, Grimes M, Johnson D, et al.: Predicting gene promoter methylation in lung tumors through examination of sputum and serum. [Abstract] J Clin Oncol 24 (Suppl 18): A-7208, 416s, 2006.

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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004859     History of Changes
Other Study ID Numbers: NCI-2012-02943
U10CA021115 ( U.S. NIH Grant/Contract )
E3598 ( Other Identifier: Eastern Cooperative Oncology Group (ECOG) )
CDR0000067510 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Results First Posted: March 22, 2012
Last Update Posted: June 2, 2014
Last Verified: February 2013
Keywords provided by National Cancer Institute (NCI):
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
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
Thalidomide
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors