Cetuximab (C225) and Radiation in Elderly and /or Poor Performance Status Patients With Locally Advanced Non-Small Cell Lung Cancer: A Phase II Study to Evaluate Survival and Toxicity
Cetuximab (C225) and Radiation in Elderly and /or Poor Performance Status Patients With Locally Advanced Non-Small Cell Lung Cancer: A Phase II Study to Evaluate Survival and Toxicity
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.
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
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
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
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
Life expectancy
* At least 12 weeks
Hematopoietic
Hepatic
Renal
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
Other
* No prior epidermal growth factor receptor inhibitors
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