Phase II Selection Design Trial Of Concurrent Chemotherapy + Cetuximab Vs. Chemotherapy Followed By Cetuximab In Advanced Non-Small Cell Lung Cancer (NSCLC)

Date de début de l'étude : 1 juillet 2004

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of one of the following stages: * Newly diagnosed selected stage IIIB disease (T4 lesion due to malignant pleural effusion, any N, M0) * Newly diagnosed stage IV disease (any T, any N, M1) * Recurrent stage IV disease after prior surgery or radiotherapy * The following subtypes are eligible: * Adenocarcinoma * Squamous cell carcinoma * Large cell carcinoma * Unspecified * Measurable disease by CT scan, MRI, x-ray, or physical exam * Pleural effusions, ascites, or laboratory parameters are not acceptable as the only evidence of disease * Not within prior radiotherapy field unless a new lesion is present * Not within area of prior surgical resection * No known brain metastases by CT scan or MRI 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 mg/dL Hepatic * Bilirubin ≤ 2 times upper limit of normal (ULN) * SGOT or SGPT ≤ 2 times ULN * Alkaline phosphatase ≤ 2 times ULN * No known acute hepatitis Renal * Creatinine ≤ ULN * Creatinine clearance ≥ 50 mL/min Cardiovascular * No significant cardiac disease * No uncontrolled hypertension * No unstable angina * No congestive heart failure Other * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission * No active or uncontrolled infection * No sensory neuropathy ≥ grade 2 * No known human anti-mouse antibodies * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No prior biologic therapy for NSCLC * No prior chimeric or murine monoclonal antibody therapy * No prior cetuximab Chemotherapy * No prior systemic chemotherapy for NSCLC Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 3 weeks since prior radiotherapy and recovered Surgery * See Disease Characteristics * At least 2 weeks since prior thoracic or major surgery and recovered Other * No prior gefitinib or other investigational agents that target the epidermal growth factor receptor pathway