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A National Web-Based Randomized Phase III Study of Erlotinib or Placebo Following Concurrent Docetaxel, Carboplatin, and Thoracic Radiotherapy in Patients With Inoperable Stage III Non-Small Cell Lung Cancer (D0410).


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Non-Small-Cell Lung, Non-small Cell Lung Cancer, NSCLC

Thank you

Trial Information

A National Web-Based Randomized Phase III Study of Erlotinib or Placebo Following Concurrent Docetaxel, Carboplatin, and Thoracic Radiotherapy in Patients With Inoperable Stage III Non-Small Cell Lung Cancer (D0410).


The promising activity of erlotinib as a single agent in advanced refractory NSCLC along
with its oral administration and favorable adverse event profile makes this agent an
excellent candidate to incorporate into combined modality therapy in the early stages of
lung cancer. Based on these data, erlotinib is an attractive novel approach to maintenance
therapy in unresectable stage III NSCLC following completion of concomitant chemoradiation.
Although, a subset of patients with unresectable stage III NSCLC will be long-term survivors
following chemotherapy and thoracic radiation therapy, the vast majority relapse within the
first year following therapy and eventually die from chemotherapy refractory disease. We
hypothesize that the introduction of an potent tyrosine kinase inhibitor to the epidermal
growth factor receptor following effective concomitant chemoradiotherapy with docetaxel and
carboplatin will prolong the progression-three survival time for these patients.


Inclusion Criteria:



- Unresectable, stage IIIA or IIIB NSCLC (measurable disease is not required)

- No evidence of metastatic disease

- No prior treatment

- Adequate organ function

- Adequate pulmonary function (FEV >= 1.0L or predicted FEV >0.8L)

Exclusion Criteria:

- Metastasis

- Prior treatment

- Malignant pleural or pericardial effusion

- Peripheral neuropathy >= grade 2

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

James R Rigas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Norris Cotton Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

D-0410

NCT ID:

NCT00153803

Start Date:

May 2005

Completion Date:

July 2013

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Non-Small Cell Lung Cancer
  • NSCLC
  • Erlotinib
  • Tarceva
  • Web based
  • Stage III NSCLC
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
Franklin Square Hospital CenterBaltimore, Maryland  21237
Aultman Cancer CenterCanton, Ohio  44710
Nevada Cancer Research FoundationLas Vegas, Nevada  89109
Winthrop University HospitalMineola, New York  11501
Florida Cancer SpecialistsFort Myers, Florida  33901
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
Washington Cancer InstituteWashington, District of Columbia  20010
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
Southeastern Medical Oncology CenterGoldsboro, North Carolina  27534
Whittingham Cancer Center at Norwalk HospitalNorwalk, Connecticut  06856
Genesis Cancer CenterHot Springs, Arkansas  71913
Morgantown Internal Medicine GroupMorgantown, West Virginia  26505
Union Memorial HospitalBaltimore, Maryland  21218
Mercy General HospitalSacramento, California  95819
The Center for Cancer and Hematologic DiseaseCherry Hill, New Jersey  08003
Methodist Cancer CenterOmaha, Nebraska  68114
Pasco Hernando Oncology AssociatesNew Port Richey, Florida  34652
Hope OncologyRichardson, Texas  75080
Kentucky Cancer ClinicPikeville, Kentucky  41501
Connecticut Oncology GroupMiddletown, Connecticut  06457
McFarland ClinicAmes, Iowa  50010
Queens Medical AssociatesFresh Meadows, New York  11365
Birmingham Hematology and Oncology Associates, LLCBirmingham, Alabama  35235
Maine Center for Cancer MedicineScarborough, Maine  04074
Blood and Cancer Center of East TexasTyler, Texas  75701
Jupiter Medical CenterJupiter, Florida  33458
Lee Cancer ClinicFort Myers, Florida  33919
Oncology Specialties, P.C.Huntsville, Alabama  35801
Cooper ClinicFort Smith, Arkansas  72913
Northstate Cancer SpecialityRedding, California  96001
St. Francis Hospital Cancer CenterHartford, Connecticut  06105
George Bray Cancer Center/New Britain General HospitalNew Britain, Connecticut  06050
Oncology and Hematology Associates, PCNew London, Connecticut  06320
Hematology/Oncology PC/Carl and Dorothy Bennet Cancer CenterStamford, Connecticut  06902
Cancer Care of North FloridaLake City, Florida  32055
Pasco/Hernando OncologyNew Port Richey, Florida  34652
Mid Florida OncologyOrange City, Florida  32763
MD AndersonOrlando, Florida  32806
Oncology & Hematology Association of West BrowardTamarac, Florida  33321
Alexian Brothers Hospital NetworkElk Grove Village, Illinois  60007
Joliet Hematology AssociatesJoliet, Illinois  60435
Investigative Clinical Research of Indiana LLCIndianapolis, Indiana  46254
Howard Regional Health SystemKokomo, Indiana  46904
Western Hematology OncologyPaducah, Kentucky  42003
Harbor View Cancer CenterBaltimore, Maryland  21225
Frederick Smith, MDChevy Chase, Maryland  20815
Community Hematology OncologyOlney, Maryland  20832
Lahey Clinic Medical CenterBurlington, Massachusetts  01805
Fallon Clinic Hematology/ OncologyWorcester, Massachusetts  01608
Bay Medical Cancer CenterBay City, Michigan  48706
Southeast Nebraska Hematology/OncologyLincoln, Nebraska  68510
Dartmouth-Hitchcock-KeeneKeene, New Hampshire  03431
Sussex County Medical AssociatesNewton, New Jersey  07860
Lincoln HospitalBronx, New York  10451
Hematology Oncology Associates of Rockland, PCNew York City, New York  10956
The Cleveland Clinic Foundation Hematology/Med OncologyCleveland, Ohio  44195
Legacy Good SamaritanPortland, Oregon  97201
SCOA-SC Onc AssocColumbia, South Carolina  29201
VA Department of Hematology/OncologyHouston, Texas  77030
Tyler Hematology/OncologyTyler, Texas  75701
Veterans Administration Medical CenterWhite River Junction, Vermont  05009
Virginia Oncology Associates Research ProgramNewport News, Virginia  23606
Olympic Hematology/OncologyBremerton, Washington  98310