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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Survival Time
Survival time is defined as time from study entry to death from any cause
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
No
Joan H. Schiller, MD
Study Chair
Simmons Cancer Center
United States: Food and Drug Administration
NCI-2012-02943
NCT00004859
January 2000
May 2011
Name | Location |
---|---|
Akron City Hospital | Akron, Ohio 44304 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
Aurora Presbyterian Hospital | Aurora, Colorado 80012 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Presbyterian - St. Luke's Medical Center | Denver, Colorado 80218 |
St. Joseph Hospital | Denver, Colorado 80218 |
Rose Medical Center | Denver, Colorado 80220 |
Swedish Medical Center | Englewood, Colorado 80110 |
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction, Colorado 81502 |
Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
Hope Cancer Care Center at Longmont United Hospital | Longmont, Colorado 80502 |
North Suburban Medical Center | Thornton, Colorado 80229 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Tufts-NEMC Cancer Center | Boston, Massachusetts 02111 |
Baystate Regional Cancer Program at D'Amour Center for Cancer Care | Springfield, Massachusetts 01199 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Foote Hospital | Jackson, Michigan 49201 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
Seton Cancer Institute - Saginaw | Saginaw, Michigan 48601 |
St. John Macomb Hospital | Warren, Michigan 48093 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
Meeker County Memorial Hospital | Lichfield, Minnesota 55355 |
HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
St. Rita's Medical Center | Lima, Ohio 45801 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
Dean Medical Center - Madison | Madison, Wisconsin 53717 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Columbus | Columbus, Ohio 43206 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Mercy Hospital Cancer Center - Scranton | Scranton, Pennsylvania 18501 |
Grand View Hospital | Sellersville, Pennsylvania 18960 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
CCOP - Greenville | Greenville, South Carolina 29615 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44106 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Medical Center of Central Georgia | Macon, Georgia 31201 |
St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
CCOP - Colorado Cancer Research Program, Incorporated | Denver, Colorado 80224 |
Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15236 |
Great Falls Clinic | Great Falls, Montana 59405 |
Overlook Hospital | Summit, New Jersey 07902-0220 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Carol G. Simon Cancer Center at Morristown Memorial Hospital | Morristown, New Jersey 07962 |
Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
Cancer Institute of New Jersey at Hamilton | Hamilton, New Jersey 08690 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx, New York 10461 |
Medical University of Ohio Cancer Center | Toledo, Ohio 43614 |
Toledo Hospital | Toledo, Ohio 43606 |
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division | Charleston, West Virginia 25302 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
Aultman Hospital Cancer Center at Aultman Health Foundation | Canton, Ohio 44710-1799 |
St. Mary's - Duluth Clinic Cancer Center | Duluth, Minnesota 55805 |
Green Bay Oncology, Limited - Escanaba | Escanaba, Michigan 49431 |
Hunterdon Regional Cancer Center at Hunterdon Medical Center | Flemington, New Jersey 08822 |
Warren Hospital | Phillipsburg, New Jersey 08865 |
Our Lady of Mercy Medical Center Comprehensive Cancer Center | Bronx, New York 10466 |
CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
Lewistown Hospital | Lewistown, Pennsylvania 17044 |
Mount Nittany Medical Center | State College, Pennsylvania 16803 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
Green Bay Oncology, Limited - Oconto Falls | Oconto Falls, Wisconsin 54154 |
Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
Hematology Oncology Associates of the Quad Cities | Bettendorf, Iowa 52722 |
Baptist Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Deaconess Billings Clinic - Downtown | Billings, Montana 59101 |
Big Sky Oncology | Great Falls, Montana 59405 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Grant Riverside Cancer Services | Columbus, Ohio 43215 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | Saint Joseph, Michigan 49085 |
MBCCOP - Medical College of Georgia Cancer Center | Augusta, Georgia 30912-3730 |
Swedish-American Regional Cancer Center | Rockford, Illinois 61104-2315 |
CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees, New Jersey 08043 |
Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
Joan Karnell Cancer Center at Pennsylvania Hospital | Philadelphia, Pennsylvania 19107 |
Jennersville Regional Hospital | West Grove, Pennsylvania 19390-9499 |
Memorial Medical Center Cancer Services | Modesto, California 95355 |
Salinas Valley Memorial Hospital | Salinas, California 93901 |
Memorial Hospital | Colorado Springs, Colorado 80909 |
St. Mary-Corwin Regional Medical Center | Pueblo, Colorado 81004 |
Swedish Covenant Hospital | Chicago, Illinois 60625 |
Mercy Hospital and Medical Center | Chicago, Illinois 60616 |
Midwest Center for Hematology/Oncology | Joliet, Illinois 60432 |
Trinity Medical Center - East | Moline, Illinois 61265 |
Hematology/Oncology of the North Shore at Gross Point Medical Center | Skokie, Illinois 60076 |
Howard Community Hospital at Howard Regional Health System | Kokomo, Indiana 46904 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
Reid Hospital & Health Care Services, Incorporated | Richmond, Indiana 47374 |
St. Luke's Hospital | Cedar Rapids, Iowa 52402 |
Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
Genesis Regional Cancer Center at Genesis Medical Center | Davenport, Iowa 52803 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Mercy Capitol Hospital | Des Moines, Iowa 50307 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | Ann Arbor, Michigan 48106-0995 |
Green Bay Oncology, Limited - Iron Mountain | Iron Mountain, Michigan 49801 |
Mercy Memorial Hospital System | Monroe, Michigan 48162 |
Alexandria, Minnesota 56308 | |
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale, Minnesota 55422-2900 |
CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
Park Nicollet Health Services | St. Louis Park, Minnesota 55416 |
Immanuel Medical Center | Omaha, Nebraska 68122 |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
Mountainside Hospital Cancer Center | Montclair, New Jersey 07042 |
Booker Cancer Center at Riverview Medical Center | Red Bank, New Jersey 07701 |
Wilson Medical Center | Wilson, North Carolina 27893-3428 |
Cancer Care Center at Medcenter One Hospital | Bismarck, North Dakota 58501 |
Bismarck Cancer Center | Bismarck, North Dakota 58501 |
St. Alexius Medical Center | Bismarck, North Dakota 58502 |
Mid Dakota Clinic, P. C. | Bismarck, North Dakota 58501 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Fremont Memorial Hospital | Fremont, Ohio 43420 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Lima Memorial Hospital | Lima, Ohio 45804 |
St. Luke's Hospital | Maumee, Ohio 43537 |
Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
St. Charles Mercy Hospital | Oregon, Ohio 43616 |
Firelands Regional Medical Center | Sandusky, Ohio 44870 |
Mercy Medical Center | Springfield, Ohio 45504 |
Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
Toledo Clinic, Incorporated - Main Clinic | Toledo, Ohio 43623 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Fulton County Health Center | Wauseon, Ohio 43567 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Hematology and Oncology Associates | Scranton, Pennsylvania 18510 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport, Tennessee 37662 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Southwest Virginia Regional Cancer Center | Norton, Virginia 24273 |
Green Bay Oncology, Limited at St. Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
DeCesaris Cancer Institute at Anne Arundel Medical Center | Annapolis, Maryland 21401 |
William W. Backus Hospital | Norwich, Connecticut 06360 |
Morton Hospital & Medical Center | Taunton, Massachusetts 02780 |
Miller-Dwan Medical Center | Duluth, Minnesota 55805 |
Lancaster General Hospital | Lancaster, Pennsylvania 17604-3555 |
Pottstown Memorial Regional Cancer Center | Pottstown, Pennsylvania 19464 |
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center | Ft. Smith, Arkansas 72903 |
Pearlman Comprehensive Cancer Center at South Georgia Medical Center | Valdosta, Georgia 31603 |
Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County | Madisonville, Kentucky 42431 |
Saint Francis Cancer Center | Shakopee, Minnesota 55379 |
St. Joseph's Hospital | St Paul, Minnesota 55102 |
Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh, Pennsylvania 15212 |
All Saints Cancer Center at All Saints Healthcare | Racine, Wisconsin 53405 |
Praxair Cancer Center at Danbury Hospital | Danbury, Connecticut 06810 |
Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville, Michigan 48144 |
Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
Stanford Comprehensive Cancer Center at Stanford University Medical Center | Stanford, California 94305 |
Easton Regional Cancer Center at Easton Hospital | Easton, Pennsylvania 18042 |
MedCentral - Mansfield Hospital | Mansfield, Ohio 44903 |
MBCCOP - Meharry Medical College - Nashville | Nashville, Tennessee 37208-3599 |
University of Virginia Cancer Center at UV Health System | Charlottesville, Virginia 22908 |
Great Falls, Montana 59405 | |
Sletten Regional Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
PinnacleHealth Regional Cancer Center at Polyclinic Hospital | Harrisburg, Pennsylvania 17105 |
Cancer Care Institute of Carolina at Aiken Regional Medical Centers | Aiken, South Carolina 29801 |
Lipson Cancer and Blood Center at Rochester General Hospital | Rochester, New York 14621 |
Halifax Medical Center - Daytona Beach | Daytona Beach, Florida 32115 |
Veterans Affairs Medical Center - Augusta | Augusta, Georgia 30904 |
Newton-Wellesley Hospital | Newton, Massachusetts 02462 |
Woodwinds Health Campus | Woodbury, Minnesota 55125 |
Shore Memorial Hospital - Somers Point | Somers Point, New Jersey 08244 |
Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center | Dubois, Pennsylvania 15801 |
Cancer Center at Phoenixville Hospital | Phoenixville, Pennsylvania 19460 |
Marshall University Medical Center | Huntington, West Virginia 25701 |