Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Carcinoma, Non-Small-Cell LungNon-small Cell Lung CancerNSCLC
- Interventions
- Drug: Placebo
- Registration Number
- NCT00153803
- Lead Sponsor
- Dartmouth-Hitchcock Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 245
- 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)
- Metastasis
- Prior treatment
- Malignant pleural or pericardial effusion
- Peripheral neuropathy >= grade 2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Erlotinib (tarceva) Erlotinib (Tarceva) 150mg: 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 3 years of therapy. 2 Placebo Matched 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 3 years of therapy.
- Primary Outcome Measures
Name Time Method Progression Free Survival 5 years Progression Free Survival is defined as time from randomization until documented disease progression or death from any cause. The Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.0) was used to determine disease progression. Irradiated target lesions were considered non-measurable disease. Symptomatic radiographic changes of irradiated non-measurable disease required pathologically confirmation or positive FDG-PET scan 6 months following completion of concurrent chemoradiation to be considered locoregional disease progression. Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression was considered distant disease progression.
- Secondary Outcome Measures
Name Time Method Overall Survival From date of randomization until the date of death from any cause, assessed up to 50 months Percent of Participants Surviving 3 Years 36 months Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Concurrent Chemoradiation 18 months Number of participants with treatment-related serious adverse events (SAEs) observed in each SAE category for each arm relating to death, disability, life-threatening, hospitalization, and impairment/damage is reported. For participants with multiple SAEs, the SAE report having the strongest relationship to study drug is summarized.
Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Erlotinib and Placebo 18 months Number of participants with treatment-related serious adverse events (SAEs) observed in each SAE category for each arm relating to death, disability, life-threatening, hospitalization, and impairment/damage is reported. For participants with multiple SAEs, the SAE report having the strongest relationship to study drug is summarized.
Trial Locations
- Locations (65)
Mercy General Hospital
🇺🇸Sacramento, California, United States
MD Anderson
🇺🇸Orlando, Florida, United States
Lincoln Hospital
🇺🇸Bronx, New York, United States
Cooper Clinic
🇺🇸Fort Smith, Arkansas, United States
George Bray Cancer Center/New Britain General Hospital
🇺🇸New Britain, Connecticut, United States
Whittingham Cancer Center at Norwalk Hospital
🇺🇸Norwalk, Connecticut, United States
Hematology/Oncology PC/Carl and Dorothy Bennet Cancer Center
🇺🇸Stamford, Connecticut, United States
Palm Beach Cancer Institute
🇺🇸West Palm Beach, Florida, United States
Fallon Clinic Hematology/ Oncology
🇺🇸Worcester, Massachusetts, United States
Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States
Queens Medical Associates
🇺🇸Fresh Meadows, New York, United States
SCOA-SC Onc Assoc
🇺🇸Columbia, South Carolina, United States
Morgantown Internal Medicine Group
🇺🇸Morgantown, West Virginia, United States
Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Birmingham Hematology and Oncology Associates, LLC
🇺🇸Birmingham, Alabama, United States
VA Department of Hematology/Oncology
🇺🇸Houston, Texas, United States
Methodist Cancer Center
🇺🇸Omaha, Nebraska, United States
St. Francis Hospital Cancer Center
🇺🇸Hartford, Connecticut, United States
Lee Cancer Clinic
🇺🇸Fort Myers, Florida, United States
Investigative Clinical Research of Indiana LLC
🇺🇸Indianapolis, Indiana, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Veterans Administration Medical Center
🇺🇸White River Junction, Vermont, United States
Pasco/Hernando Oncology
🇺🇸New Port Richey, Florida, United States
Bay Medical Cancer Center
🇺🇸Bay City, Michigan, United States
Northstate Cancer Speciality
🇺🇸Redding, California, United States
Oncology Specialties, P.C.
🇺🇸Huntsville, Alabama, United States
Genesis Cancer Center
🇺🇸Hot Springs, Arkansas, United States
Connecticut Oncology Group
🇺🇸Middletown, Connecticut, United States
Pasco Hernando Oncology Associates
🇺🇸Brooksville, Florida, United States
Jupiter Medical Center
🇺🇸Jupiter, Florida, United States
Oncology & Hematology Association of West Broward
🇺🇸Tamarac, Florida, United States
Mid Florida Oncology
🇺🇸Orange City, Florida, United States
Joliet Hematology Associates
🇺🇸Joliet, Illinois, United States
McFarland Clinic
🇺🇸Ames, Iowa, United States
Howard Regional Health System
🇺🇸Kokomo, Indiana, United States
Maine Center for Cancer Medicine
🇺🇸Scarborough, Maine, United States
Kentucky Cancer Clinic
🇺🇸Hazard, Kentucky, United States
Union Memorial Hospital
🇺🇸Baltimore, Maryland, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Harbor View Cancer Center
🇺🇸Baltimore, Maryland, United States
Franklin Square Hospital Center
🇺🇸Baltimore, Maryland, United States
Community Hematology Oncology
🇺🇸Olney, Maryland, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Frederick Smith, MD
🇺🇸Chevy Chase, Maryland, United States
Southeast Nebraska Hematology/Oncology
🇺🇸Lincoln, Nebraska, United States
Dartmouth-Hitchcock-Keene
🇺🇸Keene, New Hampshire, United States
The Center for Cancer and Hematologic Disease
🇺🇸Cherry Hill, New Jersey, United States
Sussex County Medical Associates
🇺🇸Newton, New Jersey, United States
Hematology Oncology Associates of Rockland, PC
🇺🇸New York, New York, United States
Southeastern Medical Oncology Center
🇺🇸Goldsboro, North Carolina, United States
Aultman Cancer Center
🇺🇸Canton, Ohio, United States
The Cleveland Clinic Foundation Hematology/Med Oncology
🇺🇸Cleveland, Ohio, United States
Legacy Good Samaritan
🇺🇸Portland, Oregon, United States
Hope Oncology
🇺🇸Richardson, Texas, United States
Tyler Hematology/Oncology
🇺🇸Tyler, Texas, United States
Western Hematology Oncology
🇺🇸Paducah, Kentucky, United States
Olympic Hematology/Oncology
🇺🇸Bremerton, Washington, United States
Alta Bates Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Washington Cancer Institute
🇺🇸Washington, District of Columbia, United States
Oncology and Hematology Associates, PC
🇺🇸New London, Connecticut, United States
Virginia Oncology Associates Research Program
🇺🇸Newport News, Virginia, United States
Cancer Care of North Florida
🇺🇸Lake City, Florida, United States
Alexian Brothers Hospital Network
🇺🇸Elk Grove Village, Illinois, United States
Blood and Cancer Center of East Texas
🇺🇸Tyler, Texas, United States
Lahey Clinic Medical Center
🇺🇸Burlington, Massachusetts, United States