Clinical trial NCT00153803: Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Non-small Cell Lung Cancer
NSCLC
Keywords: Erlotinib
Tarceva
Web based
Stage III NSCLC
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Sanofi
name: Genentech, Inc.
First posted: 2005-09-12
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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-free survival time for these patients.

Eligibility 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: 5 years
Secondary outcomes:
measure: Overall Survival
timeFrame: From date of randomization until the date of death from any cause, assessed up to 50 months
measure: Percent of Participants Surviving 3 Years
timeFrame: 36 months
measure: Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Concurrent Chemoradiation
timeFrame: 18 months
measure: Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Erlotinib and Placebo
timeFrame: 18 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Hematology and Oncology Associates, LLC
state: Alabama
city: Huntsville
country: United States
facility: Oncology Specialties, P.C.
state: Alabama
city: Fort Smith
country: United States
facility: Cooper Clinic
state: Arkansas
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: Berkeley
country: United States
facility: Alta Bates Comprehensive Cancer Center
state: California
city: Redding
country: United States
facility: Northstate Cancer Speciality
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Hartford
country: United States
facility: St. Francis Hospital Cancer Center
state: Connecticut
city: Middletown
country: United States
facility: Connecticut Oncology Group
state: Connecticut
city: New Britain
country: United States
facility: George Bray Cancer Center/New Britain General Hospital
state: Connecticut
city: New London
country: United States
facility: Oncology and Hematology Associates, PC
state: Connecticut
city: Norwalk
country: United States
facility: Whittingham Cancer Center at Norwalk Hospital
state: Connecticut
city: Stamford
country: United States
facility: Hematology/Oncology PC/Carl and Dorothy Bennet Cancer Center
state: Connecticut
city: Washington
country: United States
facility: Washington Cancer Institute
state: District of Columbia
city: Brooksville
country: United States
facility: Pasco Hernando Oncology Associates
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Fort Myers
country: United States
facility: Lee Cancer Clinic
state: Florida
city: Jupiter
country: United States
facility: Jupiter Medical Center
state: Florida
city: Lake City
country: United States
facility: Cancer Care of North Florida
state: Florida
city: New Port Richey
country: United States
facility: Pasco/Hernando Oncology
state: Florida
city: Orange City
country: United States
facility: Mid Florida Oncology
state: Florida
city: Orlando
country: United States
facility: MD Anderson
state: Florida
city: Tamarac
country: United States
facility: Oncology & Hematology Association of West Broward
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: Elk Grove Village
country: United States
facility: Alexian Brothers Hospital Network
state: Illinois
city: Joliet
country: United States
facility: Joliet Hematology Associates
state: Illinois
city: Indianapolis
country: United States
facility: Investigative Clinical Research of Indiana LLC
state: Indiana
city: Kokomo
country: United States
facility: Howard Regional Health System
state: Indiana
city: Ames
country: United States
facility: McFarland Clinic
state: Iowa
city: Hazard
country: United States
facility: Kentucky Cancer Clinic
state: Kentucky
city: Paducah
country: United States
facility: Western Hematology Oncology
state: Kentucky
city: Scarborough
country: United States
facility: Maine Center for Cancer Medicine
state: Maine
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Union Memorial Hospital
state: Maryland
city: Baltimore
country: United States
facility: Harbor View Cancer Center
state: Maryland
city: Baltimore
country: United States
facility: Franklin Square Hospital Center
state: Maryland
city: Chevy Chase
country: United States
facility: Frederick Smith, MD
state: Maryland
city: Olney
country: United States
facility: Community Hematology Oncology
state: Maryland
city: Burlington
country: United States
facility: Lahey Clinic Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: Fallon Clinic Hematology/ Oncology
state: Massachusetts
city: Bay City
country: United States
facility: Bay Medical Cancer Center
state: Michigan
city: Lincoln
country: United States
facility: Southeast Nebraska Hematology/Oncology
state: Nebraska
city: Omaha
country: United States
facility: Methodist Cancer Center
state: Nebraska
city: Las Vegas
country: United States
facility: Nevada Cancer Research Foundation
state: Nevada
city: Keene
country: United States
facility: Dartmouth-Hitchcock-Keene
state: New Hampshire
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center
state: New Hampshire
city: Cherry Hill
country: United States
facility: The Center for Cancer and Hematologic Disease
state: New Jersey
city: Newton
country: United States
facility: Sussex County Medical Associates
state: New Jersey
city: Bronx
country: United States
facility: Lincoln Hospital
state: New York
city: Fresh Meadows
country: United States
facility: Queens Medical Associates
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New York
country: United States
facility: Hematology Oncology Associates of Rockland, PC
state: New York
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center
state: North Carolina
city: Canton
country: United States
facility: Aultman Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation Hematology/Med Oncology
state: Ohio
city: Portland
country: United States
facility: Legacy Good Samaritan
state: Oregon
city: Columbia
country: United States
facility: SCOA-SC Onc Assoc
state: South Carolina
city: Houston
country: United States
facility: VA Department of Hematology/Oncology
state: Texas
city: Richardson
country: United States
facility: Hope Oncology
state: Texas
city: Tyler
country: United States
facility: Blood and Cancer Center of East Texas
state: Texas
city: Tyler
country: United States
facility: Tyler Hematology/Oncology
state: Texas
city: White River Junction
country: United States
facility: Veterans Administration Medical Center
state: Vermont
city: Newport News
country: United States
facility: Virginia Oncology Associates Research Program
state: Virginia
city: Bremerton
country: United States
facility: Olympic Hematology/Oncology
state: Washington
city: Morgantown
country: United States
facility: Morgantown Internal Medicine Group
state: West Virginia
Study officials:
affiliation: Norris Cotton Cancer Center
name: James R Rigas, MD
role: STUDY_CHAIR
References: