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RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the
enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.
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 make tumor cells more
sensitive to radiation therapy. Giving pemetrexed disodium, carboplatin, and radiation
therapy together with cetuximab may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium and
carboplatin together with radiation therapy with or without cetuximab works in treating
patients with stage III non-small cell lung cancer that cannot be removed by surgery.
Ages:18 and older
DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following subtypes: - Squamous cell carcinoma - Adenocarcinoma (including bronchoalveolar cell carcinoma) - Large cell anaplastic carcinoma (including giant cell and clear cell carcinoma) - Stage IIIA OR selected stage IIIB disease* - Any T, N2-3, M0 disease - T3, N1-3, M0 disease allowed provided disease is unresectable - T4, any N, M0 disease allowed provided T4 status cannot be determined due to malignant effusion - No T3, N0, M0 disease NOTE: *If the largest mediastinal lymph node is < 2 cm in diameter by CT scan, a biopsy confirmation of mediastinal nodal involvement is required - Unresectable disease - Contralateral mediastinal disease (N3) allowed provided all gross disease can be encompassed within the radiation field in accordance with the homogeneity criteria - Measurable disease, defined as ≥ 1 one-dimensional measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan - The following are not considered measurable disease: - Bone lesions - Leptomeningeal disease - Ascites - Pleural or pericardial effusion - Abdominal masses not confirmed and followed by imaging techniques - Cystic lesions - Tumor lesions in a previously irradiated area - No exudative, bloody, or cytologically positive malignant effusion - Transudate, cytologically negative, non-bloody pleural effusion allowed provided the tumor can be encompassed within a reasonable field of radiotherapy - Pleural effusion detectable by chest CT scan but not by chest x-ray that is too small to tap - New pleural effusion appearing after thoracotomy or other invasive thoracic procedure allowed - No atelectasis of the entire lung - No direct invasion of the vertebral body - No scalene, supraclavicular, or contralateral hilar node involvement - No distant metastases (M1) by fludeoxyglucose F18 positron emission tomography PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Granulocyte count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 Hepatic - Bilirubin < 1.5 times upper limit of normal (ULN) - AST and ALT < 3 times ULN - Alkaline phosphatase < 3 times ULN Renal - Creatinine clearance ≥ 45 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Not pregnant or nursing - Weight loss ≤ 10% within the past 3 months - No other active* malignancy except nonmelanoma skin cancer - No ongoing or active infection - No other uncontrolled illness - No history of hypersensitivity to carboplatin, pemetrexed disodium, or a monoclonal antibody NOTE: *Malignancy is not considered active if the patient has completed treatment and has < 30% risk of relapse PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent filgrastim (G-CSF), pegfilgrastim, or sargramostim (GM-CSF) during thoracic radiotherapy or as prophylaxis for myelosuppression Chemotherapy - No prior chemotherapy for NSCLC - No other concurrent chemotherapy Endocrine therapy - No concurrent hormonal therapy except megestrol for appetite stimulation or dexamethasone to prevent rash from pemetrexed disodium Radiotherapy - No prior radiotherapy to the chest - No concurrent palliative radiotherapy - No concurrent intensity modulated radiotherapy Surgery - See Disease Characteristics - At least 2 weeks since prior formal exploratory thoracotomy Other - No prior therapy that directly targets the epidermal growth factor receptor pathway - No concurrent combination antiretroviral therapy for HIV-positive patients
Sponsor: Cancer and Leukemia Group B
Phase: Phase 2
Trial ID: NCT00117962
Not Accepting Healthy Volunteers