An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin As Treatment For Chemotherapy-Naive Patients With Extensive Disease - Small Cell Lung

Brief Summary

Detailed Description

OBJECTIVES: * Compare the overall survival of patients with chemotherapy-naive extensive stage small cell lung cancer treated with cisplatin and oral topotecan vs cisplatin and etoposide. * Compare the response rates, response duration, and time to progression in patients treated with these regimens. * Compare the tolerability of these regimens in these patients. * Compare the patient-perceived disease status and well being in patients treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to gender, ECOG performance status (0 vs 1 vs 2), lactate dehydrogenase (less than 1.5 times upper limit of normal (ULN) vs 1.5 times ULN or greater), and country. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral topotecan once daily on days 1-5 and cisplatin IV on day 5. * Arm II: Patients receive cisplatin IV on day 1 and etoposide IV over at least 30 minutes on days 1-3. Treatment in both arms repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, prior to each course, at 4 weeks after study, and then every 4 weeks for 16 weeks. Patients are followed at 4 weeks, every 4 weeks for 16 weeks, and then every 3 months thereafter. PROJECTED ACCRUAL: Approximately 760 patients (380 per treatment arm) will be accrued for this study within 18 months.

Primary Outcomes

Not specified