A Randomized Phase III Double Blind Trial Evaluating Selective COX-2 Inhibition in COX-2 Expressing Advanced Non-Small Cell Lung Cancer

Inclusion Criteria

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