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

Phase II Study of Weekly Irinotecan and Carboplatin in Extensive-Stage Small-Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving irinotecan together with carboplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works 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