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.
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
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
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There are 135 Locations for this study
Scottsdale Arizona, 85259, United States
Hollywood Florida, 33021, United States
Jacksonville Florida, 32224, United States
Aurora Illinois, 60507, United States
Canton Illinois, 61520, United States
Carthage Illinois, 62321, United States
Effingham Illinois, 62401, United States
Eureka Illinois, 61530, United States
Galesburg Illinois, 61401, United States
Galesburg Illinois, 61401, United States
Galesburg Illinois, 61401, United States
Havana Illinois, 62644, United States
Hopedale Illinois, 61747, United States
Joliet Illinois, 60435, United States
Macomb Illinois, 61455, United States
Normal Illinois, 61761, United States
Normal Illinois, 61761, United States
Ottawa Illinois, 61350, United States
Ottawa Illinois, 61350, United States
Pekin Illinois, 61554, United States
Peoria Illinois, 61614, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61636, United States
Peru Illinois, 61354, United States
Princeton Illinois, 61356, United States
Spring Valley Illinois, 61362, United States
Spring Valley Illinois, 61362, United States
Urbana Illinois, 61801, United States
Urbana Illinois, 61801, United States
Beech Grove Indiana, 46107, United States
Michigan City Indiana, 46360, United States
Richmond Indiana, 47374, United States
Ames Iowa, 50010, United States
Cedar Rapids Iowa, 52403, United States
Des Moines Iowa, 50307, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50316, United States
Sioux City Iowa, 51101, United States
Sioux City Iowa, 51104, United States
Sioux City Iowa, 51104, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Kingman Kansas, 67068, United States
Liberal Kansas, 67901, United States
Newton Kansas, 67114, United States
Parsons Kansas, 67357, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67042, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67203, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Adrian Michigan, 49221, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48106, United States
Dearborn Michigan, 48123, United States
Flint Michigan, 48503, United States
Flint Michigan, 48503, United States
Grosse Pointe Woods Michigan, 48236, United States
Jackson Michigan, 49201, United States
Lambertville Michigan, 48144, United States
Lansing Michigan, 48912, United States
Livonia Michigan, 48154, United States
Monroe Michigan, 48162, United States
Monroe Michigan, 48162, United States
Pontiac Michigan, 48341, United States
Port Huron Michigan, 48060, United States
Saginaw Michigan, 48601, United States
Warren Michigan, 48093, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Hutchinson Minnesota, 55350, United States
Lichfield Minnesota, 55355, United States
Maplewood Minnesota, 55109, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
Robbinsdale Minnesota, 55422, United States
Rochester Minnesota, 55905, United States
Saint Louis Park Minnesota, 55416, United States
Shakopee Minnesota, 55379, United States
St Paul Minnesota, 55102, United States
St. Cloud Minnesota, 56303, United States
St. Louis Park Minnesota, 55416, United States
St. Paul Minnesota, 55101, United States
St. Paul Minnesota, 55102, United States
Waconia Minnesota, 55387, United States
Willmar Minnesota, 56201, United States
Woodbury Minnesota, 55125, United States
Woodbury Minnesota, 55125, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59107, United States
Billings Montana, 59107, United States
Bozeman Montana, 59715, United States
Butte Montana, 59701, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Helena Montana, 59601, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Missoula Montana, 59801, United States
Missoula Montana, 59804, United States
Missoula Montana, 59807, United States
Missoula Montana, 59807, United States
Omaha Nebraska, 68106, United States
Omaha Nebraska, 68122, United States
Omaha Nebraska, 68124, United States
Omaha Nebraska, 68131, United States
Rutherfordton North Carolina, 28139, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58502, United States
Grand Forks North Dakota, 58201, United States
Bowling Green Ohio, 43402, United States
Dayton Ohio, 45405, United States
Dayton Ohio, 45406, United States
Dayton Ohio, 45409, United States
Dayton Ohio, 45415, United States
Dayton Ohio, 45428, United States
Dayton Ohio, 45429, United States
Findlay Ohio, 45840, United States
Fremont Ohio, 43420, United States
Kettering Ohio, 45429, United States
Lima Ohio, 45804, United States
Maumee Ohio, 43537, United States
Maumee Ohio, 43537, United States
Middletown Ohio, 45044, United States
Oregon Ohio, 43616, United States
Oregon Ohio, 43616, United States
Sandusky Ohio, 44870, United States
Sandusky Ohio, 44870, United States
Sylvania Ohio, 43560, United States
Tiffin Ohio, 44883, United States
Toledo Ohio, 43606, United States
Toledo Ohio, 43608, United States
Toledo Ohio, 43614, United States
Toledo Ohio, 43617, United States
Toledo Ohio, 43623, United States
Troy Ohio, 45373, United States
Wauseon Ohio, 43567, United States
Wright-Patterson Afb Ohio, 45433, United States
Xenia Ohio, 45385, United States
Allentown Pennsylvania, 18105, United States
Danville Pennsylvania, 17822, United States
State College Pennsylvania, 16801, United States
Wilkes-Barre Pennsylvania, 18711, United States
Anderson South Carolina, 29621, United States
Spartanburg South Carolina, 29303, United States
Spartanburg South Carolina, 29303, United States
Rapid City South Dakota, 57701, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57117, United States
Fredericksburg Virginia, 22401, United States
La Crosse Wisconsin, 54601, United States
Sheridan Wyoming, 82801, United States
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