Gemcitabine Hydrochloride or Pemetrexed Disodium and Carboplatin With or Without Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell carcinoma of the lung, including the following cell types:

  • Adenocarcinoma
  • Large cell carcinoma
  • Squamous cell carcinoma
  • Mixture of these types
• A tissue block must be available at the time of registration
• Tumor expresses COX-2 (COX-2 index ≥ 2)

• Stage IIIB disease with malignant pleural effusion, supraclavicular node involvement, or contralateral hilar node involvement OR stage IV disease

  • Patients with stage IIIB disease who are eligible for clinical trials that involve combined chemotherapy and chest irradiation are not eligible for this study
• Patients with stage IV disease are eligible
• Patients with recurrent disease, not amenable to (or refusing) a potentially "curative therapy," are eligible

• Measurable or non-measurable disease

  • Measurable disease is defined as lesions that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 2 cm with conventional techniques or as ≥ 1 cm with spiral CT scan

  • Non-measurable disease is defined as all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly nonmeasurable lesions, including any of the following:

    • Bone lesions
    • Leptomeningeal disease
    • Ascites
    • Pleural/pericardial effusion
    • Inflammatory breast disease
    • Lymphangitis cutis/pulmonis
    • Abdominal masses that are not confirmed and followed by imaging techniques
    • Cystic lesions

• Patients with symptomatic CNS metastases are eligible provided they received prior therapy (e.g., surgery, radiotherapy, or gamma knife), are neurologically stable, and are off steroids for ≥ 14 days before study entry

  • Patients with asymptomatic CNS metastases without associated edema, shift, or requirement for steroids or antiseizure medications may be eligible after discussion with the Study Chair
  • Patients should be off steroids at least 7 days before preregistration
• No leptomeningeal disease or carcinomatous meningitis

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Granulocytes ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• Creatinine clearance ≥ 45 mL/min
• Bilirubin ≤ 1.5 mg/dL
• AST and ALT ≤ 2.0 times upper limit of normal (ULN) (≤ 5.0 times ULN if liver metastases are present)
• Serum albumin ≥ 2.5 mg/dL
• Not pregnant or nursing
• Negative pregnancy test

• No "currently active" second malignancy other than non-melanoma skin cancer

  • Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at < 30% risk of relapse
• No known hypersensitivity to aspirin, NSAIDs, or sulfonamides

• No active ulcer disease

  • No history of gastrointestinal bleeding within the past three years

• None of the following cardiovascular conditions within the past 6 months:

  • Myocardial infarction
  • Unstable angina
  • Symptomatic congestive heart failure
  • Serious uncontrolled cardiac arrhythmia
  • Cerebrovascular accident or transient ischemic attack
  • Pulmonary embolism
  • Symptomatic carotid artery or peripheral vascular disease
  • Deep vein thrombosis
  • Other significant thromboembolic event

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior chemotherapy, immunotherapy, or other systemic therapy for non-small cell lung cancer, including adjuvant therapy
• At least 2 weeks since prior surgery and recovered
• At least 7 days since prior radiotherapy

• At least 14 days since prior NSAIDs (other than low-dose aspirin [≤ 325 mg daily]), including any of the following:

  • Celecoxib
  • Choline Mg
  • Trisalicylate (Trilisate®)
  • Ibuprofen (Advil® or Motrin®)
  • Naproxen (Aleve®, Naprosyn® or Anaprox®)
  • Etodolac (Lodine®)
  • Oxaprozin (Daypro®)
  • Diflunisal (Dolobid®)
  • Nabumetone (Relafen®)
  • Tolmetin (Tolectin®)
  • Valdecoxib (Bextra®)

• No chronic use of NSAIDs (i.e., > 4 weeks of daily use)

  • Patients on low-dose aspirin are eligible
• No other concurrent chemotherapy or hormonal therapy (other than megestrol acetate [Megace] for appetite stimulation)
• No other concurrent investigational therapy