Cetuximab and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Biological: cetuximabRadiation: radiation therapy
- Registration Number
- NCT00124618
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with radiation therapy works in treating patients with stage III non-small cell lung cancer.
- Detailed Description
OBJECTIVES:
Primary
\* Determine the 11 month survival rate in older and/or poor performance status patients with stage IIIA or stage IIIB non-small cell lung cancer treated with cetuximab and radiotherapy.
Secondary
* Determine the tumor response rate, overall survival, and time to disease progression in patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
* Determine whether fear of death is less severe in the oldest of patients treated with this regimen.
* Determine whether fear of death predicts survival of patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, and 43. Beginning on day 8, patients receive concurrent radiotherapy once daily on days 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed within 1 week, at 1 and 4 months, and then every 3 months for up to 3 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 20 months
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description cetuximab/Radiation radiation therapy Cetuximab (C225) and Radiation cetuximab/Radiation cetuximab Cetuximab (C225) and Radiation
- Primary Outcome Measures
Name Time Method 11-month Survival Rate From baseline to 11 months. Eleven-month survival was chosen as the survival endpoint in this trial because it represents an improvement over the median survival that is observed with radiation alone. 11-month survival will be considered synonymous with "success", unless specified otherwise. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. All evaluable patients will be followed from the time of protocol enrollment until death or a minimum of 11 months.
- Secondary Outcome Measures
Name Time Method Survival Time From baseline to up to 3 years Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time to Disease Progression From Baseline to up to 3 years Time to disease progression is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death.
Tumor Response (Complete and Partial) Baseline, 1 month and 4 months after completion of treatment and then every 3 months until Progressive Disease (PD) or up to a maximum of 3 years from registration A confirmed tumor response is defined to be a Complete Response (CR) or Partial Response (PR) noted as the objective status on 2 consecutive evaluations at least 3 months apart. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.
Trial Locations
- Locations (174)
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Medical X-Ray Center, PC
🇺🇸Sioux Falls, South Dakota, United States
Memorial Cancer Institute at Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
InterCommunity Cancer Center of Western Illinois
🇺🇸Galesburg, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Mercy and Unity Cancer Center at Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Minnesota Oncology Hematology, PA - Woodbury
🇺🇸Woodbury, Minnesota, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Medcenter One Hospital Cancer Care Center
🇺🇸Bismarck, North Dakota, United States
St. Luke's Hospital
🇺🇸Maumee, Ohio, United States
Altru Cancer Center at Altru Hospital
🇺🇸Grand Forks, North Dakota, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Medical University of Ohio Cancer Center
🇺🇸Toledo, Ohio, United States
Fredericksburg Oncology, Incorporated
🇺🇸Fredericksburg, Virginia, United States
Hennepin County Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Sanford Cancer Center at Sanford USD Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Franciscan Skemp Healthcare - La Crosse Campus
🇺🇸La Crosse, Wisconsin, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
🇺🇸Ottawa, Illinois, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
McFarland Clinic, PC
🇺🇸Ames, Iowa, United States
St. Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
🇺🇸Lambertville, Michigan, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
Mercy Memorial Hospital - Monroe
🇺🇸Monroe, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw
🇺🇸Saginaw, Michigan, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
HealthEast Cancer Care at St. Joseph's Hospital
🇺🇸St Paul, Minnesota, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
Billings Clinic Cancer Center
🇺🇸Billings, Montana, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Big Sky Oncology
🇺🇸Great Falls, Montana, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Sletten Cancer Institute at Benefis Healthcare
🇺🇸Great Falls, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Guardian Oncology and Center for Wellness
🇺🇸Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Immanuel Medical Center
🇺🇸Omaha, Nebraska, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
St. Alexius Medical Center Cancer Center
🇺🇸Bismarck, North Dakota, United States
Wood County Oncology Center
🇺🇸Bowling Green, Ohio, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Northwest Ohio Oncology Center
🇺🇸Maumee, Ohio, United States
Fremont Memorial Hospital
🇺🇸Fremont, Ohio, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
Lima Memorial Hospital
🇺🇸Lima, Ohio, United States
Middletown Regional Hospital
🇺🇸Middletown, Ohio, United States
Firelands Regional Medical Center
🇺🇸Sandusky, Ohio, United States
St. Charles Mercy Hospital
🇺🇸Oregon, Ohio, United States
Toledo Clinic - Oregon
🇺🇸Oregon, Ohio, United States
North Coast Cancer Care, Incorporated
🇺🇸Sandusky, Ohio, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
🇺🇸Toledo, Ohio, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
United States Air Force Medical Center - Wright-Patterson
🇺🇸Wright-Patterson Afb, Ohio, United States
Fulton County Health Center
🇺🇸Wauseon, Ohio, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
🇺🇸Allentown, Pennsylvania, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Geisinger Medical Group - Scenery Park
🇺🇸State College, Pennsylvania, United States
Geisinger Cancer Institute at Geisinger Health
🇺🇸Danville, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
AnMed Cancer Center
🇺🇸Anderson, South Carolina, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Regions Hospital Cancer Care Center
🇺🇸St. Paul, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
🇺🇸Robbinsdale, Minnesota, United States
HealthEast Cancer Care at Woodwinds Health Campus
🇺🇸Woodbury, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital
🇺🇸Fridley, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center
🇺🇸Shakopee, Minnesota, United States
Park Nicollet Cancer Center
🇺🇸St. Louis Park, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital
🇺🇸Maplewood, Minnesota, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States
Meeker County Memorial Hospital
🇺🇸Lichfield, Minnesota, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Minnesota Oncology Hematology, PA - Maplewood
🇺🇸Maplewood, Minnesota, United States
Willmar Cancer Center at Rice Memorial Hospital
🇺🇸Willmar, Minnesota, United States
Mid Dakota Clinic, PC
🇺🇸Bismarck, North Dakota, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Bismarck Cancer Center
🇺🇸Bismarck, North Dakota, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
🇺🇸Omaha, Nebraska, United States
Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
Saint Joseph Mercy Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
St. Anthony's Memorial Hospital
🇺🇸Effingham, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
Valley Cancer Center
🇺🇸Spring Valley, Illinois, United States
Galesburg Clinic, PC
🇺🇸Galesburg, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
St. Mary Mercy Hospital
🇺🇸Livonia, Michigan, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Reid Hospital & Health Care Services
🇺🇸Richmond, Indiana, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸Peoria, Illinois, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
Cedar Rapids Oncology Associates
🇺🇸Cedar Rapids, Iowa, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Hickman Cancer Center at Bixby Medical Center
🇺🇸Adrian, Michigan, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Foote Memorial Hospital
🇺🇸Jackson, Michigan, United States
Community Cancer Center of Monroe
🇺🇸Monroe, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital
🇺🇸Port Huron, Michigan, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
CentraCare Clinic - River Campus
🇺🇸St. Cloud, Minnesota, United States
United Hospital
🇺🇸St. Paul, Minnesota, United States
Flower Hospital Cancer Center
🇺🇸Sylvania, Ohio, United States
Mercy Hospital of Tiffin
🇺🇸Tiffin, Ohio, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Mercy Capitol Hospital
🇺🇸Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
🇺🇸Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States