Irinotecan and Carboplatin in Treating Patients With Newly Diagnosed Extensive-Stage Small Cell Lung Cancer

OBJECTIVES:

Primary

• Determine the response rate in patients with newly diagnosed, previously untreated extensive stage small cell lung cancer treated with irinotecan and carboplatin.

Secondary

• Determine the progression-free and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive irinotecan IV and carboplatin IV on days 1 and 8. Treatment repeats every 21 days for 6 courses.

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

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed small cell lung cancer

• Extensive stage disease
• Newly diagnosed, treatment-naive disease
• At least 1 unidimensionally measurable lesion
• No massive pleural or pericardial effusion by chest CT scan

• Manageable effusions allowed

PATIENT CHARACTERISTICS:

Age

• Over 18

Performance status

• ECOG 0-2

Life expectancy

• More than 3 months

Hematopoietic

• WBC ≥ 3,000/mm^3
• Absolute granulocyte count ≥ 1,500/mm^3
• Hemoglobin ≥ 9.0 g/dL

Hepatic

• ALT or AST ≤ 2 times upper limit of normal
• Bilirubin ≤ 1.5 mg/dL

Renal

• Creatinine normal

Cardiovascular

• No myocardial infarction within the past year
• No uncontrolled hypertension
• No unstable angina
• No congestive heart failure
• No ventricular arrhythmia requiring medical intervention
• No other serious cardiovascular disease

Pulmonary

• Arterial oxygen pressure (Pa O_2) ≥ 70 mm Hg
• No interstitial pneumonitis or pulmonary fibrosis by chest x-ray

Other

• Not pregnant or nursing
• No uncontrolled diabetes
• No severe infection
• No paralytic or obstructive ileus
• No serious diarrhea
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix that is in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy to the chest

• Other prior radiotherapy allowed

Surgery

• At least 2 weeks since prior surgery and recovered