Trial Information

Phase III Randomized Study of Cisplatin and Etoposide With or Without Epirubicin and Cyclophosphamide for Extensive Stage Small Cell Lung Cancer

OBJECTIVES: I. Compare the overall survival and survival without recurrence of patients with
extensive stage small cell lung cancer after receiving cisplatin and etoposide with or
without epirubicin and cyclophosphamide. II. Compare the relative dose and intensity of
cisplatin and etoposide between the two groups of patients. III. Compare the complete and
objective response rate and quality of life of these patients. IV. Compare the toxic effects
of these 2 regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
treatment arms. Arm I: Patients receive etoposide IV on days 1 and 3 and cisplatin IV on day
2. Arm II: Patients receive etoposide and cisplatin as in arm I, plus epirubicin IV on day 1
and cyclophosphamide IV on days 1 and 3. Treatment is repeated in both arms every 28 days
for up to 6 courses. Patients who achieve a partial or complete response receive cerebral
and/or thoracic radiotherapy. Patients with residual tumor may receive oral etoposide for 3
of every 4 weeks. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 216 patients will be accrued for this study within 2.5 years.