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

Inclusion 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

- 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

Surgery

- Not specified

Other

- No prior epidermal growth factor receptor inhibitors