Cetuximab and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: cetuximab; radiation therapy
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer

Summary:

      RATIONALE: 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 stop the growth
      of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses
      high-energy x-rays to kill tumor cells. Giving cetuximab together with radiation therapy may
      kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving cetuximab together with radiation
      therapy works in treating patients with stage III non-small cell lung cancer.
    

Eligibility 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

          -  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