Irinotecan and Carboplatin as First-Line Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Inclusion Criteria:

Histologically or cytologically confirmed small cell lung cancer (SCLC)

Extensive stage small cell lung cancer

Must have ≥ 1 unidimensionally measurable lesion (longest diameter to be recorded) ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan

Lesion cannot be from a previously irradiated area

Lesions that are considered nonmeasurable include the following:

Bone lesions
Leptomeningeal disease
Ascites
Pleural/pericardial effusion
Lymphangitis cutis/pulmonis
Abdominal masses not confirmed and followed by imaging techniques
Cystic lesions
Tumor lesions in a previously irradiated area
No brain metastasis or carcinomatous meningitis unless stable and asymptomatic

PATIENT CHARACTERISTICS

ECOG performance status 0-2
Life expectancy ≥ 3 months
ANC ≥ 1,500/mm³
Platelet count > 100,000/mm³
Serum bilirubin ≤ 1.5 mg/dL
AST/SGOT ≤ 2.5 times upper limit of normal (ULN) (or ≤ 5 times ULN if liver metastases present)
Serum creatinine ≤ 2.0 mg/dl
Hemoglobin ≥ 9.0 g/dl

Exclusion Criteria:

CNS metastasis excluded unless: stable and asymptomatic
Coexisting medical condition that would preclude study compliance
Patients with Gilbert's disease
Uncontrolled diabetes mellitus, defined as random blood sugar ≥ 300 mg/dl or > 16.6 mmol/L
Patients who do not discontinue phenytoin, phenobarbitol, carbamazipine, or other enzyme-inducing anticonvulsant drugs at least 7 days prior to first treatment dose on study. Gabapentin is permitted
Patients who do not discontinue St. John's Wort prior to first treatment dose on study.
Patients who are pregnant or breast feeding
Concomitant second active malignancy except for any in situ cancer or adequately treated basal cell or squamous cell skin cancer or any cancer from which the patients has been disease-free for at least 2 years
No administration of any prior systemic anticancer therapy for extensive stage SCLC such as: chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy, cytokine therapy, or other experimental agents. Concurrent use of other anticancer therapy including inhibitors of vascular endothelial or epidermal growth factor pathways is prohibited. Prior radiation is allowed
Symptomatic brain metastasis or carcinomatous meningitis

PRIOR CONCURRENT THERAPY: