A Phase II Trial of Carboplatin and Irinotecan (CPT-11) as First-Line Therapy for 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: