Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer

OBJECTIVES:

- Determine the 18-month survival rate in patients with advanced non-small cell lung
cancer treated with carboplatin, gemcitabine, and exisulind.

- Determine the feasibility and toxicity of this regimen in these patients.

- Determine the response rate, progression-free survival, and overall median survival of
patients treated with this regimen.

OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV
over 30 minutes on day 1. Chemotherapy repeats every 21 days for up to 6 courses. Patients
also receive oral exisulind twice daily beginning on day 1 of course 1 and continuing until
disease progression or unacceptable toxicity occurs.

Patients are followed every 3 months for 2 years and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 6 months.

DISEASE CHARACTERISTICS:

- Histologically confirmed non-small cell lung cancer (NSCLC)

- Unresectable stage IIIB (e.g., pleural effusion) not suitable for combined
modality therapy OR

- Stage IV

- Prior brain metastases are allowed provided the following are true:

- Patient completed radiotherapy and/or surgery at least 3 weeks prior to study

- Objective evidence of resolution or significant improvement of brain lesions
exists on follow-up CT scan or MRI

- Patient is neurologically improved or stable

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Absolute granulocyte count at least 1,500/mm^3

- WBC at least 3,000/mm^3

- Hemoglobin at least 9 g/L

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

Hepatic:

- Bilirubin no greater than 1.25 mg/dL

- SGOT no greater than 1.5 times upper limit of normal

Renal:

- Creatinine no greater than 2.0 mg/dL OR

- Creatinine clearance at least 50 mL/min

Cardiovascular:

- No prior uncontrolled cardiovascular disease

- No hospitalization for acute myocardial infarction, arrhythmia, or congestive heart
failure within the past 3 months

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective nonhormonal contraception

- No serious active infection

- No dementia or active psychoses

- No other prior malignancy except nonmetastatic nonmelanoma skin cancer, carcinoma in
situ of the cervix, or cancer curatively treated with surgery or small-field
radiotherapy within the past 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy

Surgery:

- See Disease Characteristics

Other:

- At least 1 month since prior investigational agents

- More than 7 days since prior aspirin, sulindac, cyclo-oxygenase-2 (COX-2) inhibitors,
or nonsteroidal anti-inflammatory drugs (except ibuprofen or naproxen)

- No concurrent sulindac or COX-2 inhibitors