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