Phase III Study of Cyclophosphamide, Doxorubicin and Etoposide Compared to Carboplatin and Taxol in Patients With Extensive Disease Small Cell Lung Cancer
- Compare the effect of cyclophosphamide, doxorubicin, and etoposide with carboplatin and
paclitaxel on progression free survival in patients with extensive stage small cell
- Compare the overall survival, response rate, duration of response, and toxic effects of
these regimens in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to institute and
performance status (0-1 vs 2-3).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cyclophosphamide IV and doxorubicin IV on day 1, and etoposide
IV on days 1-3 every 3 weeks.
- Arm II: Patients receive carboplatin IV followed by paclitaxel IV over 3 hours on day 1
every 3 weeks.
Patients with stable or responding disease are treated for up to 5 courses.
Patients are followed every 4 weeks.
PROJECTED ACCRUAL: A total of 250 patients (125 per treatment arm) will be accrued within 24
months for this study.
Allocation: Randomized, Primary Purpose: Treatment
Egbert F. Smit, MD
Free University Medical Center
United States: Federal Government