Randomized Phase II Study of Eicosanoid Pathway Modulators and Cytotoxic Chemotherapy in Advanced Non-Small Cell Lung Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of 1 of
the following cellular types:

- Adenocarcinoma

- Large cell

- Squamous cell

- Mixed

- Meets 1 of the following staging criteria:

- Stage IIIB disease with malignant pleural effusion, supraclavicular node
involvement, or contralateral hilar nodes

- Stage IIIB patients eligible for Cancer and Leukemia Group B protocols of
combined chemotherapy and chest irradiation are not allowed

- Stage IV disease

- Measurable or nonmeasurable disease

- Unidimensionally measurable lesions at least 20 mm by conventional techniques OR
at least 10 mm by spiral CT scan

- The following are considered nonmeasurable disease:

- Bone lesions

- Ascites

- Pleural/pericardial effusion

- Lymphangitis cutis/pulmonis

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- Small lesions

- No leptomeningeal disease

- Symptomatic CNS metastases must be treated (e.g., surgery, radiotherapy, or gamma
knife), neurologically stable, and off steroids

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin no greater than 1.5 mg/dL

- AST no greater than 2.0 times upper limit of normal

Renal

- Creatinine no greater than 1.5 mg/dL

Cardiovascular

- None of the following within the past 6 months:

- Myocardial infarction

- Unstable angina

- Symptomatic congestive heart failure

- Serious uncontrolled cardiac arrhythmia

- Cerebrovascular accident

- Transient ischemic attack

- Symptomatic carotid artery or peripheral vascular disease

- Deep vein thrombosis

- Significant thromboembolic event

Pulmonary

- No pulmonary embolism within the past 6 months

Gastrointestinal

- No history of gastrointestinal (GI) bleeding

- No history of peptic ulcer disease

- No active GI bleeding

Other

- Not pregnant or nursing

- No known hypersensitivity to aspirin, NSAIDs, or sulfonamides

- No currently active second malignancy other than nonmelanoma 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 less than 30%
risk of relapse

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior immunotherapy for NSCLC

Chemotherapy

- No prior chemotherapy for NSCLC

- No other concurrent chemotherapy

Endocrine therapy

- See Disease Characteristics

- No concurrent chronic oral steroids

- Concurrent episodic steroids for antiemetic purposes allowed

- No concurrent hormonal therapy

- Concurrent inhaled steroids allowed when medically indicated

- Concurrent megestrol for appetite stimulation is allowed

Radiotherapy

- See Disease Characteristics

- At least 2 weeks since prior radiotherapy and recovered

Surgery

- See Disease Characteristics

- At least 2 weeks since prior surgery and recovered

Other

- No prior systemic treatments for NSCLC

- No other concurrent investigational therapy

- At least 1 week since prior nonsteroidal anti-inflammatory drugs (NSAIDs), including
any of the following:

- Rofecoxib

- Choline magnesium trisalicylate

- Ibuprofen

- Naproxen

- Etodolac

- Oxaprozin

- Diflunisal

- Nabumetone

- Tolmetin

- Valdecoxib

- No concurrent NSAIDs

- No concurrent chronic aspirin

- Concurrent aspirin no greater than 325 mg/day is allowed

- No concurrent fluconazole

- No concurrent leukotriene antagonists (e.g., zafirlukast, montelukast, or pranlukast)