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

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of carboplatin, gemcitabine, and exisulind in treating patients who have 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.

Eligibility Criteria:
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