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
- 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
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
- 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
PROJECTED ACCRUAL: Approximately 760 patients (380 per treatment arm) will be accrued for
this study within 18 months.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Nathan Levitan, MD
Case Comprehensive Cancer Center
United States: Federal Government
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|