Lung Cancer Clinical Trial

Cetuximab and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

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.

View Full Description

Full 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

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

Stage IIIA or IIIB disease
Must be a candidate for curative radiotherapy
Not a candidate for other concurrent chemotherapy and radiotherapy
No surgical treatment available
No pleural effusion suspected or proven to be malignant
No stage IV disease by bone scan or positron emission tomography scan, CT scan or MRI of the brain, and CT scan of the chest within the past 30 days

PATIENT CHARACTERISTICS:

Age * 18 and over

Performance status

Eastern Cooperative Oncology Group (ECOG) 0-2 (age ≥ 65 years)
ECOG 2 (age 18 to 64 years)

Life expectancy

* At least 12 weeks

Hematopoietic

Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 9 g/dL

Hepatic

Bilirubin ≤ 2 times upper limit of normal (ULN)
AST ≤ 3 times ULN

Renal

Creatinine ≤ 1.5 times ULN

Pulmonary

FEV_1 ≥ 1 L
No idiopathic pulmonary fibrosis

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Magnesium normal
No uncontrolled infection
No other severe underlying disease that would preclude study entry
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma
No major psychiatric illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

See Disease Characteristics
No prior chemotherapy for NSCLC

Endocrine therapy

* Not specified

Radiotherapy

No prior therapeutic radiotherapy to the chest
No concurrent intensity modulated radiotherapy

Other

* No prior epidermal growth factor receptor inhibitors

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

58

Study ID:

NCT00124618

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 135 Locations for this study

See Locations Near You

Mayo Clinic Scottsdale
Scottsdale Arizona, 85259, United States
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood Florida, 33021, United States
Mayo Clinic - Jacksonville
Jacksonville Florida, 32224, United States
Rush-Copley Cancer Care Center
Aurora Illinois, 60507, United States
Graham Hospital
Canton Illinois, 61520, United States
Memorial Hospital
Carthage Illinois, 62321, United States
St. Anthony's Memorial Hospital
Effingham Illinois, 62401, United States
Eureka Community Hospital
Eureka Illinois, 61530, United States
Galesburg Clinic, PC
Galesburg Illinois, 61401, United States
Galesburg Cottage Hospital
Galesburg Illinois, 61401, United States
InterCommunity Cancer Center of Western Illinois
Galesburg Illinois, 61401, United States
Mason District Hospital
Havana Illinois, 62644, United States
Hopedale Medical Complex
Hopedale Illinois, 61747, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet Illinois, 60435, United States
McDonough District Hospital
Macomb Illinois, 61455, United States
BroMenn Regional Medical Center
Normal Illinois, 61761, United States
Community Cancer Center
Normal Illinois, 61761, United States
Community Hospital of Ottawa
Ottawa Illinois, 61350, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa Illinois, 61350, United States
Cancer Treatment Center at Pekin Hospital
Pekin Illinois, 61554, United States
Proctor Hospital
Peoria Illinois, 61614, United States
CCOP - Illinois Oncology Research Association
Peoria Illinois, 61615, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria Illinois, 61636, United States
Illinois Valley Community Hospital
Peru Illinois, 61354, United States
Perry Memorial Hospital
Princeton Illinois, 61356, United States
St. Margaret's Hospital
Spring Valley Illinois, 61362, United States
Valley Cancer Center
Spring Valley Illinois, 61362, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove Indiana, 46107, United States
Saint Anthony Memorial Health Centers
Michigan City Indiana, 46360, United States
Reid Hospital & Health Care Services
Richmond Indiana, 47374, United States
McFarland Clinic, PC
Ames Iowa, 50010, United States
Cedar Rapids Oncology Associates
Cedar Rapids Iowa, 52403, United States
Mercy Capitol Hospital
Des Moines Iowa, 50307, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines Iowa, 50316, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City Iowa, 51104, United States
Cancer Center of Kansas, PA - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado Kansas, 67042, United States
Cancer Center of Kansas, PA - Kingman
Kingman Kansas, 67068, United States
Southwest Medical Center
Liberal Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina Kansas, 67042, United States
Cancer Center of Kansas, PA - Wellington
Wellington Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita Kansas, 67203, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita Kansas, 67214, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Wesley Medical Center
Wichita Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield Kansas, 67156, United States
Hickman Cancer Center at Bixby Medical Center
Adrian Michigan, 49221, United States
Saint Joseph Mercy Cancer Center
Ann Arbor Michigan, 48106, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan, 48106, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn Michigan, 48123, United States
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States
Hurley Medical Center
Flint Michigan, 48503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods Michigan, 48236, United States
Foote Memorial Hospital
Jackson Michigan, 49201, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville Michigan, 48144, United States
Sparrow Regional Cancer Center
Lansing Michigan, 48912, United States
St. Mary Mercy Hospital
Livonia Michigan, 48154, United States
Community Cancer Center of Monroe
Monroe Michigan, 48162, United States
Mercy Memorial Hospital - Monroe
Monroe Michigan, 48162, United States
St. Joseph Mercy Oakland
Pontiac Michigan, 48341, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron Michigan, 48060, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw Michigan, 48601, United States
St. John Macomb Hospital
Warren Michigan, 48093, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson Minnesota, 55350, United States
Meeker County Memorial Hospital
Lichfield Minnesota, 55355, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood Minnesota, 55109, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis Minnesota, 55415, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale Minnesota, 55422, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee Minnesota, 55379, United States
HealthEast Cancer Care at St. Joseph's Hospital
St Paul Minnesota, 55102, United States
CentraCare Clinic - River Campus
St. Cloud Minnesota, 56303, United States
Park Nicollet Cancer Center
St. Louis Park Minnesota, 55416, United States
Regions Hospital Cancer Care Center
St. Paul Minnesota, 55101, United States
United Hospital
St. Paul Minnesota, 55102, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
Willmar Cancer Center at Rice Memorial Hospital
Willmar Minnesota, 56201, United States
HealthEast Cancer Care at Woodwinds Health Campus
Woodbury Minnesota, 55125, United States
Minnesota Oncology Hematology, PA - Woodbury
Woodbury Minnesota, 55125, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings Montana, 59101, United States
St. Vincent Healthcare Cancer Care Services
Billings Montana, 59101, United States
Billings Clinic Cancer Center
Billings Montana, 59107, United States
Billings Clinic - Downtown
Billings Montana, 59107, United States
Bozeman Deaconess Cancer Center
Bozeman Montana, 59715, United States
St. James Healthcare Cancer Care
Butte Montana, 59701, United States
Big Sky Oncology
Great Falls Montana, 59405, United States
Great Falls Clinic - Main Facility
Great Falls Montana, 59405, United States
Sletten Cancer Institute at Benefis Healthcare
Great Falls Montana, 59405, United States

Great Falls Montana, 59405, United States
St. Peter's Hospital
Helena Montana, 59601, United States
Glacier Oncology, PLLC
Kalispell Montana, 59901, United States
Kalispell Medical Oncology at KRMC
Kalispell Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States
Community Medical Center
Missoula Montana, 59801, United States
Guardian Oncology and Center for Wellness
Missoula Montana, 59804, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula Montana, 59807, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula Montana, 59807, United States
CCOP - Missouri Valley Cancer Consortium
Omaha Nebraska, 68106, United States
Immanuel Medical Center
Omaha Nebraska, 68122, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha Nebraska, 68124, United States
Creighton University Medical Center
Omaha Nebraska, 68131, United States
Rutherford Hospital
Rutherfordton North Carolina, 28139, United States
Bismarck Cancer Center
Bismarck North Dakota, 58501, United States
Medcenter One Hospital Cancer Care Center
Bismarck North Dakota, 58501, United States
Mid Dakota Clinic, PC
Bismarck North Dakota, 58501, United States
St. Alexius Medical Center Cancer Center
Bismarck North Dakota, 58502, United States
Altru Cancer Center at Altru Hospital
Grand Forks North Dakota, 58201, United States
Wood County Oncology Center
Bowling Green Ohio, 43402, United States
Grandview Hospital
Dayton Ohio, 45405, United States
Good Samaritan Hospital
Dayton Ohio, 45406, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton Ohio, 45409, United States
Samaritan North Cancer Care Center
Dayton Ohio, 45415, United States
Veterans Affairs Medical Center - Dayton
Dayton Ohio, 45428, United States
CCOP - Dayton
Dayton Ohio, 45429, United States
Blanchard Valley Medical Associates
Findlay Ohio, 45840, United States
Fremont Memorial Hospital
Fremont Ohio, 43420, United States
Charles F. Kettering Memorial Hospital
Kettering Ohio, 45429, United States
Lima Memorial Hospital
Lima Ohio, 45804, United States
Northwest Ohio Oncology Center
Maumee Ohio, 43537, United States
St. Luke's Hospital
Maumee Ohio, 43537, United States
Middletown Regional Hospital
Middletown Ohio, 45044, United States
St. Charles Mercy Hospital
Oregon Ohio, 43616, United States
Toledo Clinic - Oregon
Oregon Ohio, 43616, United States
Firelands Regional Medical Center
Sandusky Ohio, 44870, United States
North Coast Cancer Care, Incorporated
Sandusky Ohio, 44870, United States
Flower Hospital Cancer Center
Sylvania Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin Ohio, 44883, United States
Toledo Hospital
Toledo Ohio, 43606, United States
St. Vincent Mercy Medical Center
Toledo Ohio, 43608, United States
Medical University of Ohio Cancer Center
Toledo Ohio, 43614, United States
CCOP - Toledo Community Hospital
Toledo Ohio, 43617, United States
Toledo Clinic, Incorporated - Main Clinic
Toledo Ohio, 43623, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy Ohio, 45373, United States
Fulton County Health Center
Wauseon Ohio, 43567, United States
United States Air Force Medical Center - Wright-Patterson
Wright-Patterson Afb Ohio, 45433, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia Ohio, 45385, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown Pennsylvania, 18105, United States
Geisinger Cancer Institute at Geisinger Health
Danville Pennsylvania, 17822, United States
Geisinger Medical Group - Scenery Park
State College Pennsylvania, 16801, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre Pennsylvania, 18711, United States
AnMed Cancer Center
Anderson South Carolina, 29621, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg South Carolina, 29303, United States
Rapid City Regional Hospital
Rapid City South Dakota, 57701, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Medical X-Ray Center, PC
Sioux Falls South Dakota, 57105, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls South Dakota, 57117, United States
Fredericksburg Oncology, Incorporated
Fredericksburg Virginia, 22401, United States
Franciscan Skemp Healthcare - La Crosse Campus
La Crosse Wisconsin, 54601, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan Wyoming, 82801, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

58

Study ID:

NCT00124618

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

How clear is this clinincal trial information?

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