Phase II Trial of Irinotecan Plus Paclitaxel in Patients With Advanced Nonsmall Cell Lung Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic non-small cell lung cancer for which no curative
therapy exists

- Stage IIIB with pleural effusion allowed

- Measurable or evaluable disease

- CNS metastases allowed if disease stable at least 4 weeks following completion of
surgery and/or radiotherapy and no anticonvulsant required

PATIENT CHARACTERISTICS:

Age:

- Over 18

Performance status:

- ECOG 0-2

Life expectancy:

- At least 3 months

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic:

- Bilirubin less than 2.0 mg/dL

- SGOT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN
if tumor involves liver)

Renal:

- Creatinine clearance at least 70 mL/min

Other:

- No other malignancies within past 3 years except nonmelanomatous skin cancer and
carcinoma in situ of the cervix

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective birth control

- No active infection

- No concurrent medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior systemic chemotherapy for lung cancer

- No prior irinotecan or paclitaxel

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- At least 4 weeks since prior wide field radiotherapy

- No prior radiotherapy to greater than 20% of bone marrow allowed

Surgery:

- See Disease Characteristics

- Recovered from prior surgery