A Phase II Study Of Cetuximab (C225) In Combination With Chemoradiation In Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)

Study start date: March 1, 2004

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of 1 of the following subtypes: Squamous cell carcinoma Adenocarcinoma (including bronchoalveolar cell) Large cell anaplastic carcinoma (including giant and clear cell carcinomas) Poorly differentiated/not otherwise specified NSCLC Stage IIIA (T1-2, N2, M0 or T3, N1-2, M0) or IIIB (T4, any N, M0 or any T, N2-3, M0) If the largest mediastinal node is < 2.0 cm in diameter and this is the basis for stage III disease, then at least 1 of the nodes must be cytologically or histologically positive Unresectable disease No totally resected tumors Tumors adjacent to a vertebral body allowed provided all gross disease can be encompassed in the radiation boost field and the boost volume is limited to < 50% of the ipsilateral lung volume Measurable disease Transudate, cytologically negative, non-bloody pleural effusions allowed provided the tumor can be encompassed within a reasonable field of radiotherapy Pleural effusions seen on a chest CT scan are allowed provided they are not visible on a chest x-ray and are too small to tap No asymptomatic or symptomatic brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9 g/dL (transfusion independent) Hepatic Bilirubin ≤ 1.5 mg/dL SGOT (serum glutamic oxaloacetic transaminase) or SGPT (serum glutamate pyruvate transaminase) ≤ 3 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2.5 times ULN Renal Creatinine ≤ 2.0 mg/dL Cardiovascular No significant history of cardiac disease No uncontrolled hypertension No unstable angina No uncompensated congestive heart failure No myocardial infarction within the past year No cardiac ventricular arrhythmias requiring medication LVEF (left ventricular ejection fraction) normal by MUGA (multi-gated acquisition) scan or echocardiogram Pulmonary No history of interstitial pneumonitis No history of severe chronic obstructive pulmonary disease requiring 3 or more hospitalizations within the past year FEV_1 ≥ 1,200 cc No active pulmonary infection unresponsive to conventional antibiotics Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 4 weeks after study therapy Glucose ≤ 2 times ULN No more than 5% weight loss within the past 3 months No known allergy to murine proteins or Cremophor EL No neuropathy grade 2 or greater No other malignancy within the past 2 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other in situ cancers PRIOR CONCURRENT THERAPY: Biologic therapy No prior drugs that target the epidermal growth factor receptor pathway No prior chimerized monoclonal antibody therapy No other concurrent immunotherapy No concurrent colony-stimulating factors (i.e., filgrastim [G-CSF] and sargramostim [GM-CSF]) Concurrent epoetin alfa allowed Chemotherapy No prior systemic chemotherapy No other concurrent chemotherapy Endocrine therapy No concurrent hormonal therapy except hormones for non-disease-related conditions (e.g., insulin for diabetes) or steroids for acute symptom management, adrenal failure, septic shock, or as antiemetics Radiotherapy No prior thoracic or neck radiotherapy No concurrent intensity-modulated radiotherapy Surgery Recovered from prior exploratory thoracotomy No prior surgical resection of the present cancer Other More than 30 days since prior participation in another clinical trial No concurrent participation in another clinical trial No other concurrent anticancer therapy No amifostine during or for 3 months after study radiotherapy