A Phase II Study of Irinotecan (CPT-11) and Docetaxel (Taxotere) in Patients With Recurrent Non-Small Cell Lung Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung
cancer (NSCLC) Reconfirmation of NSCLC required only if complete response for greater than
1 year Measurable or evaluable disease Tumor shrinkage or stability for at least 4 weeks
on initial chemotherapy CNS metastases allowed, if symptoms controlled for greater than 8
weeks after surgery or radiotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-1 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin normal AST no greater than 2 times upper limit of
normal (ULN) Renal: Creatinine no greater than 2.5 times ULN Cardiovascular: No New York
Heart Association class III or IV heart disease Other: No active infection At least 5
years since any other prior malignancy except curatively treated basal or squamous cell
skin cancer, carcinoma in situ, or other cancers No grade 2 or worse peripheral neuropathy
No uncontrolled diabetes mellitus No other serious underlying disease Not pregnant or
nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics No greater than 1 prior NSCLC chemotherapy regimen, excluding low dose
cisplatin as a radiosensitizer No prior irinotecan or docetaxel At least 4 weeks since
prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease
Characteristics At least 4 weeks since prior radiotherapy No prior radiotherapy to greater
than 25% of bone marrow Surgery: See Disease Characteristics Other: No concurrent
phenytoin, phenobarbital, or other anticonvulsants