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Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Treating Patients With Stage III Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
First Received: March 7, 2000   Last Updated: February 6, 2009   History of Changes
Sponsor: Eastern Cooperative Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004859
  Purpose

RATIONALE: 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.

PURPOSE: 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.


Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: paclitaxel
Drug: thalidomide
Radiation: radiation therapy
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Phase III Trial of Carboplatin, Paclitaxel and Thoracic Radiotherapy, With or Without Thalidomide, in Patients With Stage III NSCLC

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Survival at median [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression at median [ Designated as safety issue: No ]
  • Response rate at best response to treatment [ Designated as safety issue: No ]

Estimated Enrollment: 588
Study Start Date: January 2000
Detailed Description:

OBJECTIVES:

  • 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.
  • Evaluate the toxicity of the thalidomide-containing regimen and compare response rates of the two groups.
  • Determine whether the inactivation of p16, DAP-kinase, MGMT, or TIMP-3 genes can be used to predict survival in these patients treated with this regimen.
  • 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 I: Patients receive paclitaxel 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 II: Patients receive paclitaxel and carboplatin as in arm I. 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 5 days a week for 6 weeks. Arm II patients continue oral thalidomide.

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

PROJECTED ACCRUAL: A total of 588 patients will be accrued for this study within 7 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Platelet count at least 100,000/mm^3
  • WBC at least 4,000/mm^3 OR
  • Absolute neutrophil count at least 2,000/mm^3

Hepatic:

  • Bilirubin normal
  • SGOT no greater than 2.5 times upper limit of normal

Renal:

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

Cardiovascular:

  • No uncontrolled high blood pressure, unstable angina, congestive heart failure, or myocardial infarction within the prior year
  • No serious cardiac arrhythmias requiring medication

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 methods of effective contraception for 4 weeks prior to, during, and for 4 weeks after study therapy
  • No other active malignancies
  • No serious uncontrolled active infection
  • No evidence of greater than grade 1 neuropathy by history or physical examination
  • No history of seizure disorders
  • No contraindication to daily low-dose (81 mg/day) aspirin

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • At least 5 years since prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy to only area of measurable or active tumor

Surgery:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004859

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

Additional Information:
Publications:
Belinsky SA, Grimes MJ, Casas E, Stidley CA, Franklin WA, Bocklage TJ, Johnson DH, Schiller JH. Predicting gene promoter methylation in non-small-cell lung cancer by evaluating sputum and serum. Br J Cancer. 2007 Apr 23;96(8):1278-83. Epub 2007 Apr 3.
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.

Study ID Numbers: CDR0000067510, ECOG-3598
Study First Received: March 7, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00004859     History of Changes
Health Authority: United States: Food and Drug Administration

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:
Thoracic Neoplasms
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Thalidomide
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Anti-Bacterial Agents
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Growth Substances
Mitosis Modulators
Antimitotic Agents
Carboplatin
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Paclitaxel
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung

ClinicalTrials.gov processed this record on November 27, 2009