Lung cancer is the leading cause of cancer deaths in both males and females in the United States. Approximately 178,100 new cases of lung cancer will be identified in the U.S. in 1997 and approximately 20-25% of these patients will have small cell cancer (SCLC). Histologically distinct from other cell types, SCLC displays a unique biological behavior with rapid tumor proliferation, abrupt clinical presentation and a median survival of less than three months if left untreated. Combination chemotherapy produces high response rates and improved survival in SCLC. Approximately 20% of patients with limited stage disease achieve a five-year survival when treated with chemotherapy and irradiation. In contrast, patients with extensive disease have complete response of less than 30% and median survival duration of 7-11 months with almost all patients expiring within two years. A search for new drug combinations is clearly indicated for patients with extensive SCLC. The control arm in the present study will utilize the combination regimen of cisplatin 80 mg/m2/day IV over three hours on Day 1 of each 21-day cycle, and etoposide 80 mg/m2/day IV Days l-3 of each 21-day cycle. The experimental arm of the study will utilize doses used in the pilot studies with paclitaxel 175 mg/m2 IV over three hours on Day 1 followed by cisplatin 80 mg/m2 IV on Day 1 and etoposide 80 mg/m2/day IV Days 1-3, with 5 Lg/kg of G-CSF Days 4-18 of each 21-day cycle. The paclitaxel will be given on Day 1 immediately followed by the administration of cisplatin. The cisplatin and etoposide two-drug regimen will be compared with the three-drug combination including paclitaxel for differences in toxicities, response, and survival.
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