Lung Cancer
Conditions
Keywords
stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving paclitaxel together with irinotecan works in treating patients with advanced non-small cell lung cancer.
Detailed description
OBJECTIVES: * Determine the antitumor activity and toxicities of irinotecan and paclitaxel in patients with advanced non-small cell lung cancer. OUTLINE: Patients receive paclitaxel IV over 1 hour followed immediately by irinotecan IV over 30 minutes. Treatment continues weekly for 2 weeks followed by one week of rest. Courses are repeated every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, then every 6 months thereafter. PROJECTED ACCRUAL: A total of 11-22 patients will be accrued for this study over 12 months.
Interventions
DRUGirinotecan hydrochloride
DRUGpaclitaxel
Sponsors
National Cancer Institute (NCI)
Yale University
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed