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

Date de début de l'étude : 1 mars 1999

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