Combination Chemotherapy and Exisulind in Treating Patients With Extensive-Stage Small Cell Lung Cancer

OBJECTIVES:

- Determine the percentage of patients with extensive stage small cell lung cancer who
live more than 12 months after treatment with carboplatin, etoposide, and exisulind.

- Determine the response rate of patients treated with this regimen.

- Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 30-60 minutes
on days 1-3. Patients also receive oral exisulind twice daily on days 1-21. Treatment
repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity.

Patients are followed every 2 months for 1 year and then every 4 months for 2 years.

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed small cell lung cancer

- At least 1 unidimensionally measurable lesion

- At least 20 mm by conventional techniques OR

- At least 10 mm by spiral CT scan

- Lesions considered nonmeasurable include:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

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

- Cystic lesions

- Tumor lesions situated in a previously irradiated area

- Must not be considered for combined chemotherapy and radiotherapy

- No active CNS metastases

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 normal

- AST no greater than 2 times ULN

- No clinically significant hepatic disease

Renal:

- Creatinine no greater than 2.0 mg/dL OR

- Creatinine clearance at least 60 mL/min

- No clinically significant renal disease

Cardiovascular:

- No clinically significant cardiac disease

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No concurrent uncontrolled illness

- No known sensitivity to sulindac

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

- No prior chemotherapy for small cell lung cancer

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent hormonal agents except:

- Steroids for adrenal failure

- Hormones for nondisease-related conditions (e.g., insulin for diabetes)

- Intermittent use of dexamethasone as an antiemetic

Radiotherapy:

- See Disease Characteristics

- At least 2 weeks since prior radiotherapy, including for palliation

- No concurrent radiotherapy

Surgery:

- Not specified

Other:

- More than 7 days since prior sulindac

- No concurrent sulindac