Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Sanofi
Genentech, Inc.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00153803
First received: September 7, 2005
Last updated: August 1, 2013
Last verified: July 2013
  Purpose

This is a national, randomized, web-based, double-blind study to determine whether erlotinib (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with inoperable, stage III NSCLC following concurrent docetaxel, carboplatin and thoracic radiotherapy. We hypothesize that the introduction of this orally active, well-tolerated agent following concurrent chemoradiation and prior to the emergence of drug resistance will prolong the progression-free survival by 40% (10 months → 14 months).


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Non-small Cell Lung Cancer
NSCLC
Drug: Erlotinib (tarceva)
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: survival ] [ Designated as safety issue: No ]
  • 2 year survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Assess the serious adverse event profile for erlotinib [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Assess molecular targets as potential markers of efficacy [ Time Frame: optional 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 380
Study Start Date: May 2005
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Tarceva 150mg
Drug: Erlotinib (tarceva)
Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 5 years of therapy.
Placebo Comparator: 2
Matched Placebo
Drug: Placebo
Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 5 years of therapy.

Detailed Description:

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153803

  Hide Study Locations
Locations
United States, Alabama
Birmingham Hematology and Oncology Associates, LLC
Birmingham, Alabama, United States, 35235
Oncology Specialties, P.C.
Huntsville, Alabama, United States, 35801
United States, Arkansas
Cooper Clinic
Fort Smith, Arkansas, United States, 72913
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913
United States, California
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States, 94704
Northstate Cancer Speciality
Redding, California, United States, 96001
Mercy General Hospital
Sacramento, California, United States, 95816
United States, Connecticut
St. Francis Hospital Cancer Center
Hartford, Connecticut, United States, 06105
Connecticut Oncology Group
Middletown, Connecticut, United States, 06457
George Bray Cancer Center/New Britain General Hospital
New Britain, Connecticut, United States, 06050
Oncology and Hematology Associates, PC
New London, Connecticut, United States, 06320
Whittingham Cancer Center at Norwalk Hospital
Norwalk, Connecticut, United States, 06856
Hematology/Oncology PC/Carl and Dorothy Bennet Cancer Center
Stamford, Connecticut, United States, 06902
United States, District of Columbia
Washington Cancer Institute
Washington, District of Columbia, United States, 20010
United States, Florida
Pasco Hernando Oncology Associates
Brooksville, Florida, United States, 34613
Florida Cancer Specialists
Fort Meyers, Florida, United States, 33901
Lee Cancer Clinic
Ft. Myers, Florida, United States, 33919
Jupiter Medical Center
Jupiter, Florida, United States, 33458
Cancer Care of North Florida
Lake City, Florida, United States, 32055
Pasco/Hernando Oncology
New Port Richey, Florida, United States, 34652
Mid Florida Oncology
Orange City, Florida, United States, 32763
MD Anderson
Orlando, Florida, United States, 32806
Oncology & Hematology Association of West Broward
Tamarac, Florida, United States, 33321
Palm Beach Cancer Institute
West Palm Beach, Florida, United States, 33410
United States, Illinois
Alexian Brothers Hospital Network
Elk Grove Village, Illinois, United States, 60007
Joliet Hematology Associates
Joliet, Illinois, United States, 60435
United States, Indiana
Investigative Clinical Research of Indiana LLC
Indianapolis, Indiana, United States, 46254
Howard Regional Health System
Kokomo, Indiana, United States, 46904
United States, Iowa
McFarland Clinic
Ames, Iowa, United States, 50010
United States, Kentucky
Kentucky Cancer Clinic
Hazard, Kentucky, United States, 41701
Western Hematology Oncology
Paducah, Kentucky, United States, 42003
United States, Maine
Maine Center for Cancer Medicine
Scarborough, Maine, United States, 04074
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Union Memorial Hospital
Baltimore, Maryland, United States, 21218
Harbor View Cancer Center
Baltimore, Maryland, United States, 21225
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
Frederick Smith, MD
Chevy Chase, Maryland, United States, 20815
Community Hematology Oncology
Olney, Maryland, United States, 20832
United States, Massachusetts
Lahey Clinic Medical Center
Burlington, Massachusetts, United States, 01805
Fallon Clinic Hematology/ Oncology
Worcester, Massachusetts, United States, 01608
United States, Michigan
Bay Medical Cancer Center
Bay City, Michigan, United States, 48706
United States, Nebraska
Southeast Nebraska Hematology/Oncology
Lincoln, Nebraska, United States, 68510
Methodist Cancer Center
Omaha, Nebraska, United States, 68114
United States, Nevada
Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Dartmouth-Hitchcock-Keene
Keene, New Hampshire, United States, 03431
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, United States, 00000
Sussex County Medical Associates
Newton, New Jersey, United States, 07860
United States, New York
Lincoln Hospital
Bronx, New York, United States, 10451
Queens Medical Associates
Fresh Meadows, New York, United States, 11365
Winthrop University Hospital
Mineola, New York, United States, 11501
Hematology Oncology Associates of Rockland, PC
New York City, New York, United States, 10956
United States, North Carolina
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States, 27534
United States, Ohio
Aultman Cancer Center
Canton, Ohio, United States, 44710
The Cleveland Clinic Foundation Hematology/Med Oncology
Cleveland, Ohio, United States, 44195
United States, Oregon
Legacy Good Samaritan
Portland, Oregon, United States, 97201
United States, South Carolina
SCOA-SC Onc Assoc
Columbia, South Carolina, United States, 29201
United States, Texas
VA Department of Hematology/Oncology
Houston, Texas, United States, 77030
Hope Oncology
Richardson, Texas, United States, 75080
Blood and Cancer Center of East Texas
Tyler, Texas, United States, 75701
Tyler Hematology/Oncology
Tyler, Texas, United States, 75701
United States, Vermont
Veterans Administration Medical Center
White River Junction, Vermont, United States, 05009
United States, Virginia
Virginia Oncology Associates Research Program
Newport News, Virginia, United States, 23606
United States, Washington
Olympic Hematology/Oncology
Bremerton, Washington, United States, 98310
United States, West Virginia
Morgantown Internal Medicine Group
Morgantown, West Virginia, United States, 26505
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Sanofi
Genentech, Inc.
Investigators
Study Chair: James R Rigas, MD Norris Cotton Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00153803     History of Changes
Other Study ID Numbers: D-0410
Study First Received: September 7, 2005
Last Updated: August 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Dartmouth-Hitchcock Medical Center:
Erlotinib
Tarceva
Web based
Stage III NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Erlotinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014