Chemotherapy and Radiation Therapy With or Without Panitumumab in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIA non-small cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, large cell lung cancer, squamous cell lung cancer Read More

DISEASE CHARACTERISTICS:

• Histologically confirmed* non-small cell lung cancer (NSCLC), including any of the following histologies:

  • Adenocarcinoma
  • Adenosquamous
  • Large cell carcinoma
  • Squamous cell carcinoma
  • Non-lobar and non-diffuse bronchoalveolar cell carcinoma
  • NSCLC not otherwise specified NOTE: *Documentation of NSCLC may originate from the mediastinal node biopsy or aspiration

• Stage IIIA (T1-T3) disease with a single primary lung parenchymal lesion AND positive ipsilateral mediastinal node or nodes (N2) with or without positive ipsilateral hilar nodes (N1)

  • N2 nodes must be separate from primary tumor by either CT scan or surgical exploration
  • Maximum nodal diameter of involved N2 nodes cannot exceed 3.0 cm

  • N2 status must be pathologically confirmed to be positive by one of the following methods*:

    • Mediastinoscopy
    • Mediastinotomy (Chamberlain procedure)
    • Transesophageal needle biopsy using endoscopic ultrasound (EUS-TBNA)
    • Endobronchial ultrasound biopsy using endoscopic ultrasound guidance (EBUS-TBNA)
    • Thoracotomy
    • Video-assisted thoracoscopy
    • Transbronchial needle biopsy by Wang technique (TBNA)
    • Fine-needle aspiration under CT guidance NOTE: *PET positivity in the ipsilateral mediastinal lymph nodes is not sufficient to establish N2 nodal status

  • Ipsilateral mediastinal nodes associated with right-sided tumor must be biopsied unless all of the following are true:

    • Tumor is left sided
    • Paralyzed left true vocal cord documented by bronchoscopy or indirect laryngoscopy
    • Nodes visible in the anterior/posterior (level 5) region on CT scan
    • Distinct primary tumor separate from nodes visible on CT scan
    • Histologic (biopsy) or cytologic (needle aspiration or sputum) proof of non-small cell histology from the primary tumor
  • If lymph nodes in the contralateral mediastinum and neck are visible on contrast CT scan of the chest and are > 1.0 cm in short axis or if contralateral involvement is suggested by PET scan, then the nodes must be confirmed to be negative

• Measurable disease as determined by contrast-enhanced CT scan

  • Primary lung tumor distinct from mediastinal lymph nodes

• If a pleural effusion is present, the following criteria must be met to exclude malignant involvement (incurable M1a disease):

  • When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative.
  • Exudative pleural effusions are excluded, regardless of cytology;
  • Effusions that are minimal (i.e. not visible under ultrasound guidance) that are too small to safely tap are eligible.
• No palpable lymph nodes in the supraclavicular areas or higher in the neck, unless proven to be benign by fine-needle aspiration or biopsy
• No distant metastases

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-1
• Absolute neutrophil count (ANC) ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10.0 g/dL (transfusion allowed)
• Creatinine clearance ≥ 60 mL/min
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Serum albumin > 3.0 g/dL
• Serum magnesium normal (supplementation allowed)
• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after completion of treatment
• Forced expiratory volume at one second (FEV1) ≥ 2.0 L OR predicted post-resection FEV1 ≥ 0.8 L
• Diffusion capacity ≥ 50% predicted
• No other invasive malignancy within the past 3 years, except nonmelanoma skin cancer or carcinoma in situ of the breast, oral cavity, or cervix

• No severe, active co-morbidity, including any of the following:

  • Current uncontrolled cardiac disease (e.g., uncontrolled hypertension, unstable angina, myocardial infarction within the past 6 months, uncontrolled congestive heart failure, or cardiomyopathy with decreased ejection fraction (<50%)
  • Acute bacterial or fungal infection requiring IV antibiotics
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or that would preclude study therapy within the past 4 weeks
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • AIDS or known HIV positivity
• No unintentional weight loss ≥ 5% of body weight within the past 6 months
• No prior severe infusion reaction to a monoclonal antibody
• No pre-existing peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

• No prior systemic chemotherapy or biological therapy (including erlotinib hydrochloride or similar agents) for the study cancer

  • Prior chemotherapy for a different cancer allowed
• No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
• No prior therapy that specifically and directly targets the EGFR pathway