Cetuximab and Radiation Therapy 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

• 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

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